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CAR T-Cell Program Requirements

Insights From: Nilanjan Ghosh, MD, PhD, Levin Cancer Institute; David Maloney, MD, PhD Fred Hutchinson Cancer Research Center
Published: Friday, Dec 14, 2018



Transcript: 

David Maloney, MD, PhD:
A big part of any program is identifying patients who can receive this therapy. This can come from within your own group or from referrals from the outside. If patients are referred from the outside, then the program has to be able to identify whether these patients are indeed eligible for the treatment: Does their current insurance and medical necessity fit the criteria? They must determine, additionally, if the operation can even be performed.

This does require the setting up of a robust process to be able to handle everything from insurance referrals and contract negotiations with a wide variety of insurers—so that the medical team can actually evaluate these patients and move on—to the collection of cells and treatment.

One of the major issues that we’re facing is that patients can’t wait weeks to receive therapy. Those patients with, for example, diffused large B-cell lymphoma that’s refractory prior to therapy may have only weeks or months to live; time is of the essence. It’s critically important that we ty to get through these stages and steps as quickly as possible.

Once you have identified a patient who is appropriate for CAR T-cell therapy, we collect the cells by apheresis or leukopoiesis. This depends on which manufacturer you’re going to because they have different requirements for shipping cells, either fresh or cryopreserved. This requires careful coordination between your intake group and the scheduling group. The manufacturer usually requires 3 to 5 days in advance to get the products.

Once the cells are collected, you need to make sure there is an appropriate vein-to-vein collection, or it may require a central catheter. This obviously requires thinking in advance to get the line placed and manage the collection. Once the cells are collected, your cell-collection facility will ship them directly to the manufacturer or cryopreserve them. The chain of identification and custody is absolutely critical so that the procedures flow to ensure sampling returns to the same patient are timely. These are patient-specific treatments. Once the cells are collected and shipped off, we then have to monitor the patients until the anticipated date of return. It’s critically dependent on how fast the manufacturers can make the cells.

While waiting for the cells, we’re often faced with the dilemma of trying to control the lymphoma or the disease. This depends on how quick the manufacturer can make the cells and the aggressiveness of the disease. Most of these patients have relapsed or refractory disease and are in desperate need of therapy. Unlike in clinical trials, where bridging therapy is not allowed, we often are faced with having to administer bridging therapy to keep the patient alive and symptom-free.

Once the cells are received, we can schedule lymphodepletion chemotherapy and move on. Many patients will require bridging therapy—at least at this stage of the new development of these drugs, because patients are often referred after nothing else is successful. I’m hopeful that we’ll be moving  CAR T-cell therapy to earlier stages of treatment, when patients will have less disease burden.


Transcript Edited for Clarity
 
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Transcript: 

David Maloney, MD, PhD:
A big part of any program is identifying patients who can receive this therapy. This can come from within your own group or from referrals from the outside. If patients are referred from the outside, then the program has to be able to identify whether these patients are indeed eligible for the treatment: Does their current insurance and medical necessity fit the criteria? They must determine, additionally, if the operation can even be performed.

This does require the setting up of a robust process to be able to handle everything from insurance referrals and contract negotiations with a wide variety of insurers—so that the medical team can actually evaluate these patients and move on—to the collection of cells and treatment.

One of the major issues that we’re facing is that patients can’t wait weeks to receive therapy. Those patients with, for example, diffused large B-cell lymphoma that’s refractory prior to therapy may have only weeks or months to live; time is of the essence. It’s critically important that we ty to get through these stages and steps as quickly as possible.

Once you have identified a patient who is appropriate for CAR T-cell therapy, we collect the cells by apheresis or leukopoiesis. This depends on which manufacturer you’re going to because they have different requirements for shipping cells, either fresh or cryopreserved. This requires careful coordination between your intake group and the scheduling group. The manufacturer usually requires 3 to 5 days in advance to get the products.

Once the cells are collected, you need to make sure there is an appropriate vein-to-vein collection, or it may require a central catheter. This obviously requires thinking in advance to get the line placed and manage the collection. Once the cells are collected, your cell-collection facility will ship them directly to the manufacturer or cryopreserve them. The chain of identification and custody is absolutely critical so that the procedures flow to ensure sampling returns to the same patient are timely. These are patient-specific treatments. Once the cells are collected and shipped off, we then have to monitor the patients until the anticipated date of return. It’s critically dependent on how fast the manufacturers can make the cells.

While waiting for the cells, we’re often faced with the dilemma of trying to control the lymphoma or the disease. This depends on how quick the manufacturer can make the cells and the aggressiveness of the disease. Most of these patients have relapsed or refractory disease and are in desperate need of therapy. Unlike in clinical trials, where bridging therapy is not allowed, we often are faced with having to administer bridging therapy to keep the patient alive and symptom-free.

Once the cells are received, we can schedule lymphodepletion chemotherapy and move on. Many patients will require bridging therapy—at least at this stage of the new development of these drugs, because patients are often referred after nothing else is successful. I’m hopeful that we’ll be moving  CAR T-cell therapy to earlier stages of treatment, when patients will have less disease burden.


Transcript Edited for Clarity
 
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