Miguel’s Journey: Embracing CAR T-cell Therapy as a Latinx Myeloma Survivor
Miguel’s Journey: Embracing CAR T-cell Therapy as a Latinx Myeloma Survivor from Patient Empowerment Network on Vimeo.
Myeloma survivor Miguel wasn’t experiencing any symptoms when he received his shocking diagnosis. Watch as he shares his experience as a Latinx myeloma patient dealing with testing, multiple lines of treatment, and CAR T-cell therapy – and how to stay [ACT]IVATED in your care.
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Transcript:
Being ACTIVATED in CAR T-cell therapy care is critical for patients and families. My name is Miguel and I want to share my story as a myeloma survivor and Latinx man. Even though CAR T-cell therapy has improved survival rates for myeloma patients, some disparities to treatment access still persist.
I was 52 when I was diagnosed with smoldering myeloma, and my diagnosis came as a complete shock. I wasn’t experiencing any symptoms, and my doctor only discovered my condition after noticing that something looked abnormal in my blood work. After ordering further testing, my diagnosis was confirmed with a bone marrow biopsy. That was just the start of my long journey. My hematologist informed me that several rounds of chemotherapy would be best for my first line of treatment.
After I finished my rounds of chemo, my hematologist continued to monitor my tests closely for signs of recurrence. When my tests reached concerning levels, my doctor then recommended that I move forward with an autologous stem cell transplant – taken from my own stem cells.
Those were just my first two lines of therapy. My third line of therapy was an immunotherapy as part of combination therapy that worked for nearly two years. An allogeneic stem cell transplant – with stem cells taken from a donor – was recommended next. That second stem cell transplant kept my myeloma at bay for about two years. It was a nice break, and I was able to qualify for a CAR T-cell therapy when it came time to act on my fifth line of treatment. I had learned from my myeloma support group that patients need to have a lot of support to qualify for CAR T.
Patients need to have a care partner to support them, and I was fortunate enough to have my sister stay with me to help me with my appointments and recovery. CAR T-cell therapy has made the future brighter for so many myeloma patients.
There have been a lot of recent advancements in CAR T-cell therapy for myeloma. I hope that sharing my story will make a difference for other myeloma patients who may have some mistrust of doctors. Remember, become empowered and stay [ACT]IVATED with these tips.
[ACT]IVATION tips for CAR T patients:
- Ask your care team questions to learn about the status of your myeloma, treatment options, and what to expect during and after treatment.
- Inquire if a clinical trial may be a potential treatment option for your myeloma.
- Join a patient support group to offer and receive emotional support.
- Stay updated about myeloma treatment options and research advancements.
Being proactive is an essential step in your myeloma journey. Stay [ACT]IVATED by being informed, empowered, and engaged in your care.
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Enhancing Access and [ACT]IVATION in CAR T-cell Therapy
Patient Empowerment Network (PEN) has a strong commitment to providing educational content and to empowering patients and care partners in CAR T information. CAR T-cell therapy has unique eligibility and care requirements, and it’s essential for patients and families to inform themselves about the full CAR T-cell therapy process. With these objectives in mind, PEN initiated the [ACT]IVATED CAR T program, which aims to inform, empower, and engage patients to stay well-informed about CAR T therapy.
CAR T-cell therapy can be a powerful treatment option for many myeloma patients, but there are barriers to access and treatment refinements that need to be addressed for some patient populations. One key disparity is the fact that African American patients make up about 20 percent of the U.S. myeloma population but comprise less than 5 percent of myeloma clinical trial participation. PEN remains steadfast in helping to decrease disparities by offering resources on CAR T-cell therapy to aid in advocacy and awareness efforts.
Cancer survivor Lisa Hatfield interviewed experts Dr. Sikander Ailawadhi from the Mayo Clinic and Dr. Krina Patel from The University of Texas MD Anderson Cancer Center as part of [ACT]IVATED CAR T.
CAR T-Cell Therapy Eligibility Requirements
Though some myeloma patients may think eligibility to CAR T is more difficult than stem cell transplant, Dr. Krina Patel stated this is not the case. Dr. Patel also shared the success that she’s seen in patients over time. “…I have so many patients that are over a year, two years out without any therapy now. And they’re doing fantastically.
And, and again, my patients with comorbidities and my older patients, they’re the ones who benefit when we’re not on any therapy because continuous therapy ends up causing more toxicity for them. And so I think it’s really, really important to speak up to your doctor and just say, this is something I’d really be interested in.”
Dr. Patel continued to explain a key difference in inpatient versus outpatient CAR T-cell therapy eligibility requirements. Though patients who stay in the hospital for their CAR T-cell therapy don’t need a care partner with them, this isn’t the case for outpatients since a care partner is needed to monitor the patient’s symptoms. “…if you’re going to do it with outpatient, then yes, because again, when things go wrong, they can go wrong pretty fast, especially with the ICANS, neurotoxicity. So ICANS, most patients just have a little bit of trouble writing or they might have a little bit of trouble with confusion, but if that happens, you might not remember or know who to call if you’re not feeling well, right.”
CAR T-Cell Therapy Disparities
Some CAR T-cell therapy patient groups and patient types have shown different responses to therapy. One study concluded that African American patients were more likely to experience side effects from CAR T. Dr. Sikander Ailawadhi discussed research efforts that are working toward improvements. “What we are trying to do to mitigate some of these side effects, there are now studies which are giving either some low doses of steroids as a prophylaxis before, right around the time of CAR T, so that side effects may not happen. Studies that are giving a low dose or even standard dose of what’s called tocilizumab (Actemra), toci, or tocilizumab.”
African American patients in general have inflammatory disorders at a higher rate, and inflammation can impact CAR T-cell therapy side effects. Dr. Ailawadhi shares how patient monitoring is increased for African American patients at the Mayo Clinic. “…CRS, which is an immune system mediated inflammatory response, I can imagine that some of it might be higher in African Americans.
So, in our clinics, what we are doing is when we are monitoring the patients, every patient is getting monitored the same way, but when it’s an African American patient, we are putting a little bit more focus on those inflammatory markers that can sometimes start showing up even before the CRS happens.”
Side effect prevention also helps with reducing other barriers to CAR T as a treatment option. Dr. Ailawadhi shared, “…by preventing the side effects, we are being able to give the treatment in a way that the patients may have lesser side effects and can get it done closer to home or at home sometimes, and their time to stay in the hospital is lesser. You can imagine that some of these barriers are being further mitigated.”
Solutions to Overcome CAR T Disparity Gaps
Some myeloma patient groups may face barriers to or disparities in CAR T-cell therapy, but some efforts to solutions are underway. Dr. Ailawadhi discussed some roadblocks to CAR T care for Black and Latinx patients. “A lot of times they are sociodemographic, patients need to take time away from work. They have to have a caregiver, they have to have appropriate insurance approvals for certain things. They have to be able to go to a center that may be close to them.
These centers are hopefully going to be able to bring some other resources like social workers, navigators, et cetera, to help that patient get onto the trial. And then there is sometimes lack of awareness of CAR T, lack of awareness of clinical trials per se, clinical, and there are fears, anxiety, scares around getting on clinical research.”
Myeloma patients who live in rural areas may now have options to access CAR T-cell therapy through the use of telemedicine and remote monitoring. Dr. Ailawadhi painted a detailed picture of how his care of an international patient has been handled from her introduction through the care she’s receiving today. “She had some family members and some means that she could actually come here, so she came to the U.S., did a consult, we did a visit, we took over her treatment, she got CAR T, but then a month or so after that she was doing fine and she wanted to go back home.
She was here with some family members living in a foreign country, not speaking the language, et cetera. Her children were very supportive and spoke English. So, she went back and I still continue to do video visits with her just to see how she’s doing, monitor her disease, she sends me records through the electronic medical system portal, I can see her labs, and I think it gives me peace of mind that I’m keeping an eye on it, it gives her peace of mind.”
Additional barriers to CAR T access include language and cultural barriers. Dr. Ailawadhi discussed how Spanish language versions of CAR T educational materials are being introduced. And he shared the idea that patients are often more receptive to healthcare providers who look and speak like them. “…we have African American, Hispanic, Asian clinical research coordinators in our teams, and we have noticed a clear difference in the patient’s understanding their ability to ask questions, their willingness to ask questions and clear out their barriers if it is given to them in a culturally sensitive, culturally appropriate manner.”
[ACT]IVATED CAR T Program Resources
The [ACT]IVATED CAR T program series takes a three-part approach to inform, empower, and engage myeloma patients and patient groups who experience health disparities. The series includes the following resources:
- [ACT]IVATED Expert Interviews
- [ACT]IVATED Patient Vignette
- [ACT]IVATED Toolkit
- [ACT]IVATED CAR T Resources
Though there are some special eligibility requirements for CAR T-cell therapy and some care and treatment disparities exist, CAR T can be a powerful treatment option for many patients and continues to increase with equity and access improvement efforts. We hope you can take advantage of these valuable resources to assist in building knowledge about CAR T-cell therapy for yourself or for your loved one and to help expand awareness around CAR T.
[ACT]IVATED CAR T-Cell Therapy Patient Plan
Thank you for taking this assessment. By answering the questions below, a custom patient plan featuring a collection of vetted resources will be emailed to you within 5 minutes. If you don’t see it, please be sure to check your spam. Stay [ACT]IVATED.
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CAR T-Cell Therapy Patient Eligibility | What Patients Should Know
CAR T-Cell Therapy Patient Eligibility | What Patients Should Know from Patient Empowerment Network on Vimeo.
What should CAR T-cell therapy patients know about patient eligibility? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center discusses transplant eligibility factors, why the factors are examined, and proactive advice for patients.
[ACT[IVATION TIP
“…tell your doctor, “I’m interested in CAR T. I want to go talk to a CAR T center.” And that’s where they can tell you if something is possible or not.”
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Related Resources:
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What Is the Impact of CAR T-Cell Therapy Access Barriers on Patients? |
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CAR T-Cell Therapy Follow-Up Monitoring | What Patients Can Expect |
Transcript:
Lisa Hatfield:
Dr. Patel, what challenges exist in navigating the complexities of patient eligibility criteria for CAR T therapy, particularly in the context of comorbidities and prior treatments and how can these challenges be navigated more effectively?
Dr. Krina Patel:
Yeah, I think it’s, people compare it to stem cell transplant all the time, and that’s my biggest activation tip. Transplant eligibility is not the same as CAR T eligibility. CAR T eligibility is much easier. So the absolute contraindication I would say for CAR T, is probably my patients with dementia, right? Because some of the chemo that we give prior to the CAR T can worsen that. And things like ICANS, this neurotoxicity can worsen some of those symptoms and we don’t want that.
That’s where I would use a bispecific instead where we’ve seen some great responses, but everybody else, again, even if you’re on dialysis and you have kidney failure, we can change the dosing of that chemo and patients do really well with CAR T. We work with the nephrologist, to make sure we don’t cause volume overload or anything else that they’re doing dialysis on time. We’re changing things up, etcetera. Patients with cardiomyopathy, so heart failure, again, we don’t want to go in when you have active heart failure, but just because you have a history of heart failure, we can do things to make sure that you don’t get, again, volume overload or, too much pressure on your heart.
Even patients with history of strokes, in the clinical trials that wasn’t allowed, but in the real world, again, as long as you’re not needing active therapy for your stroke, meaning, blood thinners, things like that yet anymore, then we can actually still potentially get you through CAR T. We have patients who aren’t able to speak.
They have expressive aphasia from history of stroke, but we actually have charts where we can figure out what their ICE scores are for ICANS. And we can make sure we, that they’re not having neurotoxicity. So we have other means by making sure that things are going well during that CAR T therapy that I think it’s really up to them. If they’re interested in it, my activation tip here is tell your doctor, “I’m interested in CAR T. I want to go talk to a CAR T center.” And that’s where they can tell you if something is possible or not. And I will say for the most part, most of my patients can get through CAR T. Again, we’ll talk about the different products. We’ll talk about how we would do it, how we would change it potentially.
But again, I have so many patients that are over a year, two years out without any therapy now. And they’re doing fantastically. And, and again, my patients with comorbidities and my older patients, they’re the ones who benefit when we’re not on any therapy because continuous therapy ends up causing more toxicity for them. And so I think it’s really, really important to speak up to your doctor and just say, this is something I’d really be interested in. And, any one of our centers would be happy to explain what we would do differently as well as, which product is the best one for you based on that risk comorbidity and the risk-benefit ratio.
Lisa Hatfield:
That again is great information. I’m glad you addressed the kidney dysfunction issue because we have several people in our support group who worry that they won’t be eligible for CAR T therapy because they have kidney dysfunction. So they’re all seeing specialists, which is the way to go for patients, to always see a specialist. So thank you so much, Dr. Patel.
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What CAR T Research Is Ongoing to Improve Treatment Response?
What CAR T Research Is Ongoing to Improve Treatment Response? from Patient Empowerment Network on Vimeo.
How can CAR T treatment response be improved with research? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center discusses the CARTITUDE, KARMMA-9, and LEGEND studies and proactive patient advice about bispecific therapy and CAR T.
[ACT[IVATION TIP
“…before you start bispecific therapy, talk to your doctor about CAR T. And the reason I say that is that when you get a bispecific therapy, and currently that is not a fixed duration therapy, it is a continuous therapy. So patients are on it until they relapse. And the problem is that once you relapse on that T-cell therapy, your risk of losing BCMA, losing the antigen is much higher. There are mutations that we’re seeing that most patients get.”
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Transcript:
Lisa Hatfield:
So, Dr. Patel, given the risk of relapse following initial CAR T therapy, what approaches are being investigated to enhance the persistence and durability of CAR T-cell responses in patients? I know there are a lot of theories out there saying things like antigen loss might be an issue, the loss of the target BCMA, T-cell exhaustion, the environment of the bone marrow, what of those theories are being investigated or looked at?
Dr. Krina Patel:
Yeah, I think without causing too many issues with why we think CAR T is so great, where it’s a one-and-done, right? That gives people this wonderful time off. In the relapsed/refractory setting, I think our goal is can we use CAR T to cure, right? That is the ultimate question. And, again, with cilta-cel (ciltacabtagene autoleucel) [Carvykti], with the original data from the LEGEND study, which was the original study in China, those patients had a little bit less therapy than CARTITUDE. However, there are about 15 percent of patients that are six years out from their CAR T still in remission, right?
And so that gives us a little bit of hope that maybe we’ll have a small tail and a small number of patients that are cured from our current CAR T approaches. But the question is, how do we now increase that tail and make it more like lymphoma? And then hopefully, 90, 100 percent of patients eventually, how can we, how can you get everyone cured? And so I think it comes down to myeloma is not the same for everybody, right? So you have our high-risk patients versus our standard-risk patients. And I think the strategies are going to be different for those two patient populations.
They already are in the way we treat patients with even induction therapy and maintenance and consolidation. We tend to be much more aggressive with folks who have high-risk disease versus those who don’t. And so, I think the biggest studies right now that are looking at this are really the combination studies. And so looking at CAR T followed by some type of maintenance, but fixed duration maintenance. So CARTITUDE 5 and 6 and KarMMa-9, these are all the studies of the BCMA CAR Ts in frontline. All of them will have maintenance afterwards, but it seems to be that they’re going to be two years of LEN maintenance and that’s it, nothing after that.
So LEN, lenalidomide (Revlimid), we know that it activates T cells. It activates other immune cells like NK cells in the body, even B cells. And so when you get cytokine release syndrome from the CAR T, you’re already making more of these immune cells and activating them. And now you’re going to have lenalidomide in there to kind of keep that going, right? And so that could help with this, not persistence of the CAR T itself, but persistence of better immune cells that can actually keep your myeloma down, right? So I think that’s one way.
The other way is some of the new therapies like CELMoDs. So these are sort of the newer version of lenalidomide and pomalidomide. They tend to have more immune effect than the other two drugs. So there’s studies looking at other CAR Ts, so a different target, right? So we talked about antigen loss. If you’ve lost BCMA, then what do we do?
Well, there’s other targets like GPRC5D. So a couple of the studies are looking at GPRC5D-CAR-T plus mezigdomide, which is one of the CELMoDs, or another arm is iberdomide, which is the other CELMoD, and looking at different doses without causing too many side effects, but still helping the T cell keep going, all kinds of things going on there. So those are some interesting studies.
And one of the cohorts, it’s actually using a GPRC5D-CAR-T with a BCMA bispecific after, that’s combinations. So now you’re targeting two different antigens and you’re using T cells in two different ways, right? And again, it’s fixed duration so that it’s not forever, but after a certain period, hopefully, we fix the bone marrow and we’ve killed enough myeloma that hopefully it won’t come back.
And so I think all of those are different strategies for the T-cell exhaustion to help with that, to hopefully keep from getting antigen loss, or if someone does have antigen loss, figuring out a way to go around it. And then the microenvironment I think is the biggest one, is how do we find cytokines and other things that can give us a bone marrow microenvironment that makes it really inhospitable for that myeloma to ever come back again.
So there are early Phase I studies looking at some of this, but I think down the line, that’s really what it will be, that once people go into their stringent CRs, MRD undetectable, now what can we do to keep that bone marrow from ever letting it grow again? And I think those are some interesting studies in the future.
Lisa Hatfield:
Okay. Thank you. So some patients are asked questions about the sequencing, and you’d mentioned different therapies. So I’ll ask this really quickly as follow-up, do you have any recommended or are there recommended sequencing of these different therapies like CAR T, then bispecifics, then CELMoDs, not all of them are FDA-approved at this point, but what are your thoughts on sequencing of those therapies?
Dr. Krina Patel:
So my activation tip here is that before you start bispecific therapy, talk to your doctor about CAR T. And the reason I say that is that when you get a bispecific therapy, and currently that is not a fixed duration therapy, it is a continuous therapy. So patients are on it until they relapse. And the problem is that once you relapse on that T-cell therapy, your risk of losing BCMA, losing the antigen is much higher. There are mutations that we’re seeing that most patients get.
So that means the next time we try to use a different BCMA therapy, there’s a big chance it’s not going to work. And we have small studies that show that, that people who get a bispecific, and then we try to go to CAR T for both CAR Ts that the response rates go down and the progression-free survival. So the months that patients get without, needing other therapy goes down for cilta-cel (ciltacabtagene autoleucel) [Carvykti], 33 months in CARTITUDE. It goes down to six months in CARTITUDE-2 where they did CAR T after prior BCMA therapy. That’s a huge drop.
In ide-cel, the real-world data, we saw that after bispecifics, you only get 2.8 months. If you get a CAR T, even though the response rates were still 70, 80 percent, it obviously there are clones that that BCMA isn’t there anymore that we can’t kill. And then it just grows back, right? The other way around, we actually see still a really good response because CAR T is a one-and-done, most of the time, you’re not going to lose BCMA.
So that let’s say a few years later, the myeloma was coming back. It usually has the same BCMA on there. So now I can use a bispecific. And yes, the PFS is still shorter than what you would see if you never had any BCMA therapy. It’s still in the realm of, almost a year, PFS though. So it’s much closer to what we see in the real world for bispecifics than the other way around for CAR T, it’s much, much lower. So we try to do CAR T first then bispecific, if possible. The other part is a T cell. So if you try to make T cells right after someone’s coming off of a bispecific, it is really hard to get T cells that are functional that then we can actually put a CAR into and make it work. So again, why, doing a CAR T first, and then a bispecific makes the most sense for the majority of our patients if they can do it that way.
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CAR T-Cell Therapy Follow-Up Monitoring | What Patients Can Expect
CAR T-Cell Therapy Follow-Up Monitoring | What Patients Can Expect from Patient Empowerment Network on Vimeo.
What can CAR T-cell therapy patients expect for follow-up monitoring? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center discusses how long follow-up monitoring is typically carried out, issues that are monitored for, and proactive advice for patients to help ensure optimal care.
[ACT[IVATION TIP
“…for long-term side effects really is infections, number one, because even after I just saw a patient last week whose IgG level’s still less than 100 even a year after CAR T. We’ve just knocked out the good and the bad, and so it was just a higher risk of infection, so we try to prevent by giving IVIG regularly, and so again, any time you get an infection, just talk to your doctors, don’t say, ‘This is just a cold,’ just make sure that someone’s following.”
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Related Resources:
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What Is the Impact of CAR T-Cell Therapy Access Barriers on Patients? |
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Transcript:
Lisa Hatfield:
Dr. Patel, if a patient is or has been part of a clinical trial involving CAR T, how long will that patient be followed under the clinical trial protocol for long-term effects, and this is especially important for people who see community oncologists and are wondering about any latent effects that they might experience, how long were those clinical trials follow those patients?
Dr. Krina Patel:
That’s a great question. So most trials will follow for at least two years just for toxicity, efficacy, now, most trials will follow until you’re relapsing, so that’s the point, is that we want to make sure this is working, that you don’t have any long-term toxicity, and when you relapse, we call that the progression-free survival, which is what most of the trials are looking at, and once you relapse, usually they’ll say, Okay, you’re coming off a trial because now you need other therapy and that could take years.
And however, for all CAR T products, because these are genetically modified, the FDA requires that you go into a long-term protocol where we’re monitoring for potential leukemias or lymphomas that T cells can cause, theoretically. So that is for 15 years, total. So everyone then is supposed to go on to that, now we can’t force you to go on to those, but it is something important because it’s come up recently that maybe some of these T-cell products are leading to leukemia or lymphoma, because we’re modifying those T cells could they themselves turn into a cell that causes cancer.
The theoretical risk has always been there, I will tell you that in reality, yes, there have been probably a handful of patients out of all the lymphoma and myeloma and leukemia patients who’ve been treated with CAR T where maybe it came from the T cell itself, the actual CAR T. The majority of other cases that have been reported, it’s been a low risk, it’s less than what we usually see in the general population of patients with blood cancers that get other blood cancers.
But when we see it, most of the time, it’s not in the T cell where the CAR was in, but again, a handful have been, and that is really why as a group, we have to be really careful and make sure that some of the different. The way we make CAR T is very different amongst the products, and to make sure that one product versus another isn’t more likely to cause T-cell leukemias or lymphomas. So that’s the main reason why that 15-year protocol exists.
Lisa Hatfield:
And do you have any tips for patients who maybe have undergone CAR T therapy, are several years out and working with our community oncologist, what should they be watching for in terms of any late in side effects or long-term side effects?
Dr. Krina Patel:
So I think the activation tip here for long-term side effects really is infections, number one, because even after I just saw a patient last week whose IgG level’s still less than 100 even a year after CAR T. We’ve just knocked out the good and the bad, and so it was just a higher risk of infection, so we try to prevent by giving IVIG regularly, and so again, any time you get an infection, just talk to your doctors, don’t say, “This is just a cold,” just make sure that someone’s following.
And the other big thing is your blood count, so if your blood counts start doing something crazy, your white count’s getting high or too low, you’re not on any therapy, your hemoglobin is getting really low, your platelets are getting low, that’s where we want to make sure there’s not a secondary cancer, a secondary blood cancer involved. Again, T-cell leukemia myeloma was really rare, but we have seen 10 percent patients with MDS or AML in the relapse refractory population, so that is something else we would still want to watch out for and make sure we don’t miss that.
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What Are CAR T-Cell Therapy Requirements for Care Partners?
What Are CAR T-Cell Therapy Requirements for Care Partners? from Patient Empowerment Network on Vimeo.
What requirements do CAR T-cell therapy care partners need to meet? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center discusses CAR T-cell therapy care partner requirements, the reasoning for the requirements, and specific side effect conditions they need to be on the lookout for.
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Related Resources:
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What Is the Impact of CAR T-Cell Therapy Access Barriers on Patients? |
CAR T-Cell Therapy Follow-Up Monitoring | What Patients Can Expect |
What CAR T Research Is Ongoing to Improve Treatment Response? |
Transcript:
Lisa Hatfield:
With their caregiver eligibility requirements, does a patient have to have a caregiver with them during the initial part of the CAR-T therapy?
Dr. Krina Patel:
Yeah. So, unfortunately, if you’re going to do it with outpatient, then yes, because again, when things go wrong, they can go wrong pretty fast, especially with the ICANS, neurotoxicity. So ICANS, most patients just have a little bit of trouble writing or they might have a little bit of trouble with confusion, but if that happens, you might not remember or know who to call if you’re not feeling well, right.
Now when you’re in hospital, we actually say, No, you don’t need a caregiver with you, it’s nice to have somebody because we could pick up on things a lot faster, so if someone calls somebody the wrong name, it happens once in a while but they’re doing it consistently. I might not recognized that, but my patient’s caregiver will recognize it, they repeatedly, they called me this name instead of this name.
So little things like that, but at the same time, you don’t have to have a caregiver when you’re in the hospital because we’re watching you 24/7. So for that period that sometimes our patients stay for about a week or so, you don’t need somebody, but after that when you are outpatient, at least until you get home and you’re out of that period of ICANS and CRS, we do need somebody with you just to make sure if something bad doesn’t happen, and that if something is happening, they can call 911 or at least get you to the hospital relatively quickly. And that’s why there’s time limits, you can’t be farther than, for some trials, 30 minutes outside the hospital where you’re getting your CAR T.
So say two hours. Again, for us, we usually say 30 minutes is probably the longest, just because Houston, the traffic is so crazy too sometimes, that we want to make sure that you can get to the hospital quickly, even though it’s a lot less likely chance of getting high grade ICANS it’s less than 5 percent, but if you are that patient, we want to be able to get you into the hospital quickly and reverse it quickly.
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What Is the Impact of CAR T-Cell Therapy Access Barriers on Patients?
What Is the Impact of CAR T-Cell Therapy Access Barriers on Patients? from Patient Empowerment Network on Vimeo.
How do CAR T-cell therapy access barriers impact patients? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center discusses factors that create CAR T-cell therapy access barriers and the impacts of FACT accreditation and the REMS program.
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Related Resources:
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CAR T-Cell Therapy Patient Eligibility | What Patients Should Know |
What CAR T Research Is Ongoing to Improve Treatment Response? |
Transcript:
Lisa Hatfield:
Dr. Patel, how do you perceive the impact of patient access barriers, such as geographical constraints and caregiver requirements on the widespread adoption of CAR T therapies for myeloma patients?
Dr. Krina Patel:
Yeah, so this is a huge, huge problem. I think I’m such a big CAR T fan because again, it works so well, it gives people this amazing quality of life, so once they can get it, it’s phenomenal, and people want it again, if they can get it again down the road. But you have to get there, and so the biggest barriers, I will say is insurance coverage, making sure your insurance, now most people who have insurance it will cover, but some people with Medicare, if they don’t have a secondary, that 20 percent that you have to cover is insane. I don’t think most people would not be able to do that. So that’s number one.
Number two is location. And again, if you can’t come somewhere, there’s about 200 centers in the U.S. that are FACT-accredited, and you have to be…it’s an acronym basically for anyone that does cell therapy, and you have to be accredited to be able to give CAR T, so unlike other therapies like bispecifics that are not under that jurisdiction, for CAR T, you have to have that designation, so there are quite a few centers around the country that have that.
But again, access to myeloma CAR Ts is still limited to a certain degree, and so finding a place that’s nearby and having a caregiver, these are all really, really important, but we’re hoping that in the future with better CAR Ts, we won’t have to worry about staying in the vicinity for 30 days. We’re actually trying to push already to say that a lot of our patients, the majority do really well, that after two weeks, they should be able to go back home, and we can work with their local oncologist, their local doctors to make sure everything’s okay.
I think the original CAR Ts were in lymphoma and there were some pretty significant side effects we saw, so even that can’t drive for eight weeks and all these other things that we all have to do, all our patients have to do now came from that, even though most of our patients don’t get neurotoxicity, right, in myeloma, we don’t see those things. So again, we’re trying to find novel ways to push back and say to the FDA, do we really need these patients to stay here this long when our data looks so much different and better than it does for other diseases?
So I think that’s part of it as well. Through some of our newer trials, we’re trying to see if we can decrease those recommendations that once they get approved, it won’t be a part of the REMS program and all these things that. If once it becomes part of the REMS program, we have to do it and it’s hard to reverse that. But I know a lot of the companies are, and myeloma groups are trying to get together to decrease some of that burden, because it might be a little bit too much for the majority of our patients where they don’t need it medically and I know it would help them get access to the drugs, but coming back to the novel CAR Ts, there are ways to make the CAR T in less than 48 hours now that people are testing, and if we can do that, that can really decrease your time of even having to come get your cells collected, then go back home for bridging therapy, then come back for the actual CAR T treatment.
And if we can give it to you faster and we can decrease that toxicity, then hopefully again, it could be two weeks and then we get you back home. So I think that’s the ultimate goal. I just don’t know when that will happen.
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A Look at Promising Strategies to Improve CAR T-Cell Therapy Access
A Look at Promising Strategies to Improve CAR T-Cell Therapy Access from Patient Empowerment Network on Vimeo.
How can CAR T-cell therapy access be improved? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center explains strategies that have increased CAR T access, monitoring of CAR T patients, and advice for patients to access support.
[ACT]IVATION TIP
“…talk to your teams, if it’s not the doctor, at least the nurse practitioner or the nurses about resources, because through the pharmaceutical companies as well as things like LLS and other places, they actually have funds for people going through trials or CAR T therapies, etcetera, that we can help. My nurse knows all these things that she knows how to start working in our social worker and our case managers, they all know all these things so that they can get you the resources you need…”
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What Patient Types Are Good Candidates for CAR T-Cell Therapy? |
Are There Myeloma Trials Investigating CAR T for Frontline Therapy? |
Transcript:
Lisa Hatfield:
Dr. Patel, given the exacerbation of existing barriers during the COVID-19 pandemic, what strategies do you believe are most promising for enhancing patient access to CAR T therapy, particularly in terms of innovative clinical trial designs and stakeholder collaboration? And one of the questions that comes up a lot is during COVID I was able to participate in a clinical trial, but I could do some things closer to home where we don’t have a big center. Are those strategies still in play? So patients might be able to travel, maybe once a month or once every two months for a CAR T trial and then go home for a little while. Can you talk about that a little bit?
Dr. Krina Patel:
Yeah, I think COVID did help us learn how to use telehealth much more, where when it was allowed, I think the good news when we had it, we could do it for all 50 states. It was amazing. All my patients I could talk to through virtual visits, etcetera, use their local labs. Clinical trials are a little harder because you have to have labs that are certified and making sure that they’re able to do those intricate labs that you need.
For instance, certain things are central labs for where they have to look at your T cells and how they’re expanding over time while you’re getting CAR Ts. So we call those central labs because those are labs we draw and send to the company, to whatever lab they’re using to help with that stuff. Things like CBC, your blood counts, your kidneys, liver. Yes, those things are easy to get anywhere. There are multiple labs like Quest and Labcorp, etcetera, that can do those.
So I think those are things that we can help with. It’s the first 30 days of any CAR T study that for safety reasons right now, we still say you have to be at the center where you’re getting the CAR T on trial or even off a standard of care. And that’s more for if you get one of these toxicities like the delayed neurotox or an infection, that we can get you back into the hospital if needed or at least get you diagnosed really quickly and treated quickly.
But yes, after those 30 days, at least most of our CAR T studies really try to limit how often you have to come in. So once a month is pretty typical and then once every three months after the first couple of years, and then once a year if that. I hope that with the FDA and with our sponsors, our pharmaceutical companies that run these trials, that they can really help get these things, the logistics figured out, because that’s what it ends up being. Once you’re done with your first at least three months of CAR T, we know patients are going to do well. And it’s really about whatever labs and visits we need to do, how can we do them virtually? And again, if my sponsors and the FDA would allow that, we’d be really happy to.
And I know the FDA is all for it. They are trying to help increase access as well. And so some of the bigger centers like us, and I think Sloan Kettering and City of Hope and Mayo, we also have other centers that are outside of the main campus. So MD Anderson doesn’t have other hospitals the way Mayo does. So Mayo has Arizona, has Rochester, and Florida. MD Anderson has a sister network.
And so we’re hoping to tap into that one day, because there are places everywhere. And if we can do that, that would actually help get access to a lot of these novel therapies a lot faster to our patients. And within Houston, just being such a big city, we have four other centers out in the outskirts and we are trying to actually increase our abilities to do therapies there as well, including CAR T and bispecific therapies.
Lisa Hatfield:
Thank you for that, Dr. Patel. So one question, I have a follow-up question. If a patient has to travel, maybe they live in an area where there is no academic center, they’d have to travel for a clinical trial. And you mentioned the first 30 days. Are patients usually, one of the big challenges is financial, is a financial challenge. Are patients sometimes feeling well enough during that 30 days if they can work remotely? Can they work remotely while they’re at your institution for 30 days? Is that pretty typical or is that something you don’t see very often?
Dr. Krina Patel:
Yeah, no, that’s a great question. So we are trying to make the whole thing outpatient soon, and a lot of our trials are allowing for CAR T outpatient, and only if you get a fever, then we admit, most people do get admitted because most people get fevers from the CAR T, but for the most part patients still feel well, it’s not that they’re having this horrible nausea, vomiting, diarrhea, things that we think about with auto transplant, where people really can’t work because they’re just exhausted. The majority of our patients are bored in the hospital, it really is that we’re just there just in case the fever turns into something worse. So a lot of my patients who are still working actually do work remotely, I can think of a few just this past week that talked about the fact that they were able to do this.
And I think the other piece we have so many resources. And again, the big activation tip here is talk to your teams, if it’s not the doctor, at least the nurse practitioner or the nurses about resources, because through the pharmaceutical companies as well as things like LLS and other places, they actually have funds for people going through trials or CAR T therapies, etcetera, that we can help.
My nurse knows all these things that she knows how to start working and our social worker and our case managers, they all know all these things so that they can get you the resources you need and some of the centers, our academic centers have resources as well. We have housing for free, you have to sign up for it in advance, but you might be able to get housing for free for that whole 30 days, and so there’s a lot of different resources that you just have to ask about, and then again, through our social worker, case manager, nurses, and sponsors. We can actually get some of that for you too.
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Are There Myeloma Trials Investigating CAR T for Frontline Therapy?
Are There Myeloma Trials Investigating CAR T for Frontline Therapy? from Patient Empowerment Network on Vimeo.
Is it possible for CAR T-cell therapy to be used as a frontline therapy? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center sits down with her patient, Lisa Hatfield to discuss CAR T-cell clinical trials, including CARTITUDE-4, KarMMa-2, and KarMMA-9, and trials currently under study.
[ACT]IVATION TIP
“…talking to a myeloma specialist about different options that are out there for trials because different centers will have different trials that are open and you need someone to help you navigate with that. Which ones are the best ones for you? And then I would say talking to your patient advocacy groups, because that’s really where a lot of my patients hear the information. And then they come to me and say, ‘Listen, I heard this, what does it mean?’ And I think that really helps you kind of even know where to start from.”
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Related Resources:
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|
What Patient Types Are Good Candidates for CAR T-Cell Therapy? |
A Look at Promising Strategies to Improve CAR T-Cell Therapy Access |
Transcript:
Lisa Hatfield:
So, Dr. Patel, for this next question, I’m going to preface it by saying that anybody that I have ever talked to in my advocacy work about myeloma and how to get care for myeloma, I’m a huge advocate for seeing a myeloma specialist. And I will tell everybody out there that Dr. Patel at MD Anderson is my myeloma specialist, and I’ve been with her since I was diagnosed in 2018. I live in an area where we don’t have any myeloma specialists. And so I’m an advocate for that. And anybody listening, I hope that they know that they can seek out the care of a specialist even for initial consult or even once throughout their journey.
Having said all that, I know Dr. Patel, because you’ve talked to me about them before, that you’re involved in some clinical trials for CAR T therapy. Can you talk a little bit about your trials that you’re doing right now that offer CAR T in earlier lines of therapy, including frontline therapy, and what this could mean for patients?
Dr. Krina Patel:
Yeah, no, I think the CAR T trials are what allowed us to even get to second and third line. The KarMMa-3 and CARTITUDE-4 were the two trials that brought ide-cel (idecabtagene vicleucel) [Abecma] and cilta-cel (ciltacabtagene autoleucel) [Carvykti] forward, which is fantastic. And I think now it’s how can we improve even further? So some of our clinical trials are even earlier line, like you said, frontline. So we have one called KarMMa-9 that is for patients who have less than a VGPR, meaning that they didn’t get all their myeloma gone after their initial transplant, if they went to transplant, you can do consolidation with CAR T. And we’ve had a few patients that we did on a smaller study called KarMMa-2 that are doing really well after they were on that cohort for that study.
So that’s sort of why they’re doing a bigger study for FDA approval now. And then CAR T 2-5 and 6, we don’t have that at MD Anderson, but a lot of centers do. But that is now trying to see if cilta-cel can actually beat stem cell transplant, which again, a lot of us are really excited about, but we need to do the trial to make sure it’s just as safe and hopefully more efficacious. So I think those are really, really important. Auto-transplant, I was a transplanter when I first became faculty at MD Anderson.
And so I do think it has a role, but it’s high-dose chemo and there are secondary potential side effects that can happen. And people really have to kind of stop their lives for at least two, three months, if not longer, to go through that. Where in CAR T, I think it’s that quality of life piece. Again, it’s one and done. It doesn’t take as long to recover for the majority of patients. And it really is using immune therapy instead of chemo to kill that myeloma, right? So it is very different.
And we’ve seen some amazing depth of response for CAR T compared to what we see with the normal chemotherapy. So the other piece is how we have other trials that are doing earlier lines. So there’s new CAR Ts that are coming out, hopefully in the near future as a standard of care. So there’s one called ddBCMA. It’s a study by Arcellx. And the big news was that Kite, which is one of the big lymphoma CAR T companies, just took over to do their big Phase III study.
So hopefully we’ll have FDA approval for this in the next year with our Phase II study. But the Phase III will be in second line forward just like the CAR T 2-4 was. And this CAR T, it’s different in the way it’s built. And we really don’t see any of the neurotoxicity at all so far, which has been pretty impressive. But we see the same efficacy that we saw with cilta-cel. So this could be sort of best of both worlds, knock on wood. But so far we’ve seen some really great responses. And I think that trial being offered earlier will be great as well for a lot of our patients to get something that might be better than what we have already. The other trials are with other targets.
So we do have some studies that are looking at different targets instead of BCMA. So now we have patients who have already had CAR T with BCMA and over time, years, for the most part, they’re relapsing. And so now we have GPRC5D CAR Ts that are actually being combined with different things to then be able to give them a little bit earlier rather than waiting till after BCMA or fifth line, etcetera. So we have lots of trials looking at all different ways to combine CAR Ts or newer versions of the BCMA CAR Ts that I think are really, really exciting. And I think it’s really hard to keep up with this.
So my activation tip here is really talking to a myeloma specialist about different options that are out there for trials because different centers will have different trials that are open and you need someone to help you navigate with that. Which ones are the best ones for you? And then I would say talking to your patient advocacy groups, because that’s really where a lot of my patients hear the information. And then they come to me and say, “Listen, I heard this, what does it mean?” And I think that really helps you kind of even know where to start from.
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How Can Variable Patient Groups Be Addressed in CAR T?
How Can Variable Patient Groups Be Addressed in CAR T? from Patient Empowerment Network on Vimeo.
Can CAR T-cell therapy address variable patient groups? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center discusses variances in different myeloma patient groups, the KarMMa-3 study, and proactive advice for patients.
[ACT]IVATION TIP
“…if you are in a area, let’s say rural America where you don’t have access or you are in a minority population, African American, Hispanic, etcetera, or older, frail patients who are older that are considered vulnerable as well, absolutely make sure to talk to your doctors about these novel therapies because you still can get them safely and they will work. They can work. You just have to go to a center where they know how to adjust those types of therapies to make sure you get the best options out there as well.”
Download Guide | Descargar Guía
See More from [ACT]IVATED CAR T
Related Resources:
|
What Patient Types Are Good Candidates for CAR T-Cell Therapy? |
Are There Myeloma Trials Investigating CAR T for Frontline Therapy? |
A Look at Promising Strategies to Improve CAR T-Cell Therapy Access |
Transcript:
Lisa Hatfield:
Dr. Patel, how might the heterogeneity of patient populations impact the standardization and reproducibility of CAR T therapy outcomes across different clinical settings, and what initiatives are in place to address this variability?
Dr. Krina Patel:
Yeah, I think that’s a great question because again, this is a personalized therapy. So it depends on what your myeloma is like, the genomics, the genetics of your myeloma, how aggressive is it, plus your T cells, right? And so everybody’s genetic ancestry, etcetera, is very different. So the idea of a personalized medicine, more than just even across groups of people, it’s at the individual level. And I think when you talk about different races or ethnicities, we have seen some differences in our real-world data, in very relapsed/refractory patients, where people can get great response rates still.
So, for instance, Caucasian patients versus African American patients, our response rates are still high in the 80s and 90 percent, but the toxicity is a little bit higher in our African American patients. It’s still not high grade. It’s not anything that makes me say, I’m not going to give this, but the baseline inflammatory markers are a little bit higher. And so once we get the CAR T, our patients tend to get a little bit more CRS.
They end up in the hospital a little bit longer. Now, again, this is a multivariate analysis and we couldn’t find any other difference, but when we look at KarMMa-3, which is one of our big studies that led to ide-cel (idecabtagene vicleucel) [Abecma] being approved early, we actually had an outcomes of African American patients only that we looked at and that we presented just this past TCT, and response rates were actually a little bit better.
Again, you can’t compare them because the numbers aren’t there to power that to compare, but numerically the numbers were better in terms of response rate, in terms of progression-free survival, it was actually more months that it beat the standard of care and we didn’t see more toxicity.
And so I think we do need to look at these things and make sure there’s not one group of patients has a lower efficacy for some reason, and why is that and how can we improve that? And so far, we don’t really see that. And the other is the toxicity piece, to make sure that these therapies that do cause some strange toxicities that we’re watching and seeing who might be more vulnerable to those toxicities, who do we need to maybe even prevent, do prevention strategies for, but so far we haven’t seen it.
And then I think coming back to the individual, right?So again, all of us have these different T cells that have different mutations in them, and some folks, for some reason, even with less myeloma, their T cells just expand really fast and other folks, they don’t. And so in the future to get best outcomes, we need to see how we can turn the volume lower for those folks who have really sensitive T cells.
And for those who don’t, how do we, what else can we add in combination to actually increase those T cells so that they’re actually doing a better job at killing the myeloma, right? And including the microenvironment too. So I think there’s a lot of translational work as well as the epidemiology side of things to say, okay, how do we first diagnose the problem, find the problems, and then how do we figure out how to intervene to then improve outcomes for all our patients? I think the activation tip here is that if you are in a area, let’s say rural America where you don’t have access or you are in a minority population, African American, Hispanic, etcetera, or older, frail patients who are older that are considered vulnerable as well, absolutely make sure to talk to your doctors about these novel therapies because you still can get them safely and they will work. They can work. You just have to go to a center where they know how to adjust those types of therapies to make sure you get the best options out there as well.
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