Dr. Ciara Freeman, a myeloma specialist from Moffitt Cancer Center, helps patients and care partners understand the day-to-day reality of CAR T-cell therapy. Dr. Freeman provides an overview of what happens on the day of the infusion, reviews side effects to watch for after the process, and explains how patients are monitored in the days and weeks following CAR T-cell therapy.
Dr. Ciara Freeman is an Associate Member and Clinical Research Medical Director in the Department of Blood and Marrow Transplant and Cellular Immunotherapy at Moffitt Cancer Center in Tampa, FL. Learn more about Dr. Freeman.
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Transcript
Laura Beth Ezzell:
Let’s help our viewers better understand what to expect when they’re actually undergoing therapy. First of all, how long does the process take?
Dr. Ciara Freeman:
So, once we get the product back, usually we’ll see them fairly quickly. We tend to plan anticipating when we’ll get the product back. So, we’ll usually get a heads up from whoever’s making the cells. This is when we’re most likely going to get the cells back, and we’ll plan for the patient to come accordingly.
As I said, we have a fully outpatient program. So, we don’t admit patients unless there’s a mandate as part of their clinical trial that we have to admit them. And so, they’ll come. They’ll see their primary team, make sure everything’s going okay, and that they’ve had a good response to their bridging therapy, and that they’re well.
And then, basically, we start seeing them as an outpatient. So, basically, we see them every day. So, they’ll be seen the day before they start. And then, they have their three days of chemotherapy, which prepares them for the CAR T to go in.
That three days of chemotherapy is fairly standard across all the products and trials, where the cells are the patient’s own cells that get sent off and are put back in the patient’s body. And then, the cell infusion happens two days later. The infusion itself is brief, and sort of some patients will consider it to be somewhat of an anti-climax. It’s a very small amount of product that goes in, for something that seems like such a big deal.
Oftentimes, nothing happens for an initial period of time. So, the products vary in terms of when they will cause what’s called cytokine release. So, that’s where the cells meet the tumor, and they get all jazzed up, and they release these chemicals called cytokines; and that can cause a flu-like syndrome in the patient.
That’s called cytokine release syndrome. When that happens, the first fever, we will admit the patient for observation. And we bring them in, make sure that they’re doing okay, make sure that there isn’t an infection that we’re missing, and keep a close eye on them and monitor them very closely.
The FDA recently changed their guidance about how long a time the patient has to remain near a major center like Moffitt for monitoring. And so, we’re evaluating how long it is before patients can reasonably be allowed to go home. So, there was a period of time where patients were told they couldn’t drive for eight weeks. And then, we did a lot of work with the consortium, showing that patients really didn’t have any neurological issues that persisted beyond the first month.
And so, that mandate was lifted, that patients could drive sooner than that. So, usually sometime between three and four weeks after the cells go in, the patients are able to go home and basically sort of recuperate from the process.
We’ll monitor them quite closely. And obviously, if anything happens at home, they’ll call us, let us know, and then we’ll decide whether we bring them back for an evaluation if they’ve got an infection brewing, or there’s something else that we’re worried about. And then, we see them periodically for disease assessment, response assessments, and vaccines.
So, we revaccinate our patients after CAR T. So, that’s the general overview, but what patients really love is, in the overwhelming majority, after the CAR T goes in, they’re on no treatment directed towards myeloma for the first time in a really long time, and they really love that. They love being off therapy.
Laura Beth Ezzell:
Okay. So, there’s nothing extra that they’re doing in between this time.
Dr. Ciara Freeman:
No, it’s more just about keeping an eye on things. So, some patients will have sometimes a low immunity, and so, we’ll support them with pooled antibody therapy.
So, that’s something that we do often do once a month for the first period, just to keep them well, and sort of reduce their risk of especially chest or sinus infections while the immune system is recalibrating. Some patients have some minor fatigue or other issues, but most of those are temporary; but close monitoring allows for us to have early intervention, which is key.