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CAR T-Cell Program Feasibility in the Community Setting

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:
Here in Seattle at the Bezos Family Immunotherapy Clinic, which was one of the first clinics set up for cellular immunotherapy, we have a wide range of clinical trials available for patients, as well as both of the commercial products. The exact mix is tricky because it depends on when cells can be potentially available, the histologies and the diagnoses of the patients, and then insurance coverage. Many times, these dictate whether patients are going on clinical trials or getting commercial agents. I think the commercial agents are picking up over time, but right now the minority of the patients have been on commercial agents and the majority, on clinical trials.

There are many challenges associated with the delivery of CAR T-cell therapy—and right now we have a limited number of centers that are approved to be able to give the treatment. For this to be more widely accepted, there are several things that have to happen. One is more centers have to be set up that can safely do this treatment. Secondly, the companies have to be better at product delivery in shorter time frames, so patients can survive long enough to get through the therapy.

I’m not aware of any community centers that are functioning as CAR T-cell approved centers at this time. There are a number of major hurdles that have to be overcome for this. The first factor is accreditation: I believe that most insurers will eventually require that centers be factor credited in the new immune-effector-cell criteria; most transplant programs are already doing this. That’s why most of these programs have been associated with large academic programs such as transplant centers, since it is a challenge to become factor credited. The major issues are not just taking care of the patient but ensuring that there’s a chain of identification between the collection of cells and the delivery of those cells to and from the manufacturing center, and then administration back to the patient.

There are many challenges again to outpatient delivery of CAR T-cell therapy. Here in Seattle we have extensive experience in being able to do that, but that’s because we have a very robust transplant program that developed outpatient allogeneic stem-cell transplant. Because of that, we can ensure that we have 24-7 triage available for patients, who are required to live very close to the center—within 20 minutes—so they can be directly admitted to the hospital in the middle of the night, or anytime of the day, for the occurrence of symptoms consistent with cytokine release syndrome or neurological toxicity. Centers have to be able to address these issues.


Transcript Edited for Clarity
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Transcript: 

David Maloney, MD, PhD:
Here in Seattle at the Bezos Family Immunotherapy Clinic, which was one of the first clinics set up for cellular immunotherapy, we have a wide range of clinical trials available for patients, as well as both of the commercial products. The exact mix is tricky because it depends on when cells can be potentially available, the histologies and the diagnoses of the patients, and then insurance coverage. Many times, these dictate whether patients are going on clinical trials or getting commercial agents. I think the commercial agents are picking up over time, but right now the minority of the patients have been on commercial agents and the majority, on clinical trials.

There are many challenges associated with the delivery of CAR T-cell therapy—and right now we have a limited number of centers that are approved to be able to give the treatment. For this to be more widely accepted, there are several things that have to happen. One is more centers have to be set up that can safely do this treatment. Secondly, the companies have to be better at product delivery in shorter time frames, so patients can survive long enough to get through the therapy.

I’m not aware of any community centers that are functioning as CAR T-cell approved centers at this time. There are a number of major hurdles that have to be overcome for this. The first factor is accreditation: I believe that most insurers will eventually require that centers be factor credited in the new immune-effector-cell criteria; most transplant programs are already doing this. That’s why most of these programs have been associated with large academic programs such as transplant centers, since it is a challenge to become factor credited. The major issues are not just taking care of the patient but ensuring that there’s a chain of identification between the collection of cells and the delivery of those cells to and from the manufacturing center, and then administration back to the patient.

There are many challenges again to outpatient delivery of CAR T-cell therapy. Here in Seattle we have extensive experience in being able to do that, but that’s because we have a very robust transplant program that developed outpatient allogeneic stem-cell transplant. Because of that, we can ensure that we have 24-7 triage available for patients, who are required to live very close to the center—within 20 minutes—so they can be directly admitted to the hospital in the middle of the night, or anytime of the day, for the occurrence of symptoms consistent with cytokine release syndrome or neurological toxicity. Centers have to be able to address these issues.


Transcript Edited for Clarity
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