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Are There Myeloma Trials Investigating CAR T for Frontline Therapy?

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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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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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Myeloma Research | CAR T-Cell Therapy Clinical Trials

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Myeloma Research | CAR T-Cell Therapy Clinical Trials from Patient Empowerment Network on Vimeo.

What new CAR T-cell therapies are being studied in clinical trials? Dr. Adriana Rossi shares an overview of alternatives to CAR T-cell therapy, information about the latest CAR T clinical trials, and advice for patients that may be interested in participating in a trial.

Dr. Adriana Rossi is co-director of the CAR T and stem cell transplant program at the Center for Excellence for Multiple Myeloma at Mount Sinai Health System in New York City. Learn more about Dr. Rossi.

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Transcript:

Katherine Banwell:

What are the alternatives if a patient decides CAR T is not right for them?  

Dr. Adriana Rossi:

I would say as part of this newest revolution and fairly comparable in novelty and method of action would be the bispecific antibodies. So, these are molecules.  

They are not cells. And they activate the patient’s own T cells and bring the T cells to the myeloma, causing very similar side effect profile and very similar effectiveness. The rates are a little bit lower but they are administered as mostly a subcutaneous injection that has to be dosed weekly or every other week. The contrast is it’s a continuous therapy, but it does allow us to adjust as we go, which the cellular therapy doesn’t.  

Katherine Banwell:

While there are approved CAR T-cell therapies for myeloma currently, there are also many others that are in clinical trials. Would you talk about some of the ongoing research in this area?  

Dr. Adriana Rossi:

Absolutely. Again, while we celebrate the tremendous changes that these two CAR Ts have made to the field, they are both autologous, meaning we use the patient’s own T cells for manufacturing. They both target BCMA.  

And they are both what we call second generation T cells. So, other areas are to change the target. So, instead of just targeting BCMA, there are studies specifically targeting GPRC5D, which are coming down fairly soon. Rather than using the patient’s own T cells there are a number of products that use a healthy donor’s T cells, which are available immediately.  

So, we don’t need to go through the bridging therapy, and we don’t have to wait for the cells to be ready. And lastly, there are different manufacturing processes. As I mentioned, the ones we currently have may take up to eight weeks for manufacturing. There are some studies now where cells are basically manufactured, engineered, in 48 hours –  

Katherine Banwell:

Oh, wow.  

Dr. Adriana Rossi:

– and are ready to be infused so that they actually grow in the patient rather than in a Petri dish. So, lots of areas of exploration and I look forward to, in five years, being able to look back and see again how the field has changed.  

Katherine Banwell:

And I’m sure it will, by the sounds of it. Are there any trials introducing CAR T-cell therapy as an earlier line of myeloma treatment?  

Dr. Adriana Rossi:

There are. So, both the products that are now commercially available for the fourth line are being studied in earlier and earlier lines. We actually just this year got results of the CARTITUDE-4 study, which was in one to three prior lines, and expect that that will lead to an earlier approval in the very near future.  

And we have a number of studies, again, with both products looking at patients who have either high risk disease or don’t respond as well as we would like to their frontline therapy, and actually being used as part of that first line.  

Katherine Banwell:

Dr. Rossi, what advice do you have for patients who may be hesitant to participate in a clinical trial?  

Dr. Adriana Rossi:

Education. More than anything, understand what they are. Clinical trials come in all shapes and sizes. We have these exciting molecules that have to go into a first human at some point but we also have tried and true therapies that we know – for example, the CAR T – that is approved in these later lines. That same product is being now offered earlier. So, that has to be within a clinical trial because it’s not the approved indication.  

But it is a product that we know to be safe. We know that it works in advanced disease and are actually expecting that it will work even better in earlier lines. So, clinical trials is a very broad term. Understanding what the patient may be eligible for – meaning, what the study’s looking for – and then comparing that to what the patient is looking for. So, sometimes it’s even modes of therapy. So, if you’re specifically looking for an oral agent, there may be studies that don’t require injections or that many visits. So, really looking widely, speaking to your healthcare physician, and understanding what the options are.   

Katherine Banwell:

And if a patient is interested in possibly participating in a clinical trial, what sorts of questions should they ask?  

Dr. Adriana Rossi:

Very, very good question. First, understanding what clinical trial. Each center will have their own combination. Some studies are available in multiple locations. Some studies are very institution specific. So, meeting with the research team and understanding what are the required testings, what is the required treatments, and what is the required follow-up, I think, is the first part.   

Clinical trials, in order for them to give us the power to generalize and learn lessons are very strict in trying to keep to the schedule just as specified and everything is much more contained. So, making sure that they again understand what they’re signing up for and what they’ll get out of it.