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Selection Criteria for CAR T Therapy & Infusion Process

Insights From: Nilanjan Ghosh, MD, PhD, Levin Cancer Institute; David Maloney, MD, PhD Fred Hutchinson Cancer Research Center
Published: Sunday, Dec 02, 2018



Transcript: 

Nilanjan Ghosh, MD, PhD: At this time, most of the sites that are offering CAR T therapy are academic site, which do stem-cell transplantation. If we think of the future and look to expand to community sites, which will obviously increase the access to patients to get CAR T therapy, we have to be mindful about maintaining the same set of criteria and guidelines, which we have used so far, so that the quality of collection as well as administration and patient toxicity management remains the same, irrespective of the site. We obviously should have the same standards for academic and community settings, but I think that if community sites are able to—knowing the details of what is entailed in offering CAR T therapies—then it’s a significant investment, which can certainly be done.

The first step in offering CAR T therapy is to find if a patient is eligible or not. The way to do that is to ignore the disease that the patient has in the FDA-approved indication. Relapsed and refractory diffuse large B-cell lymphoma, transformed follicular lymphoma, or primary mediastinal B-cell lymphoma after failure of 2 prior therapies. The next part of the process is to see if they meet this criteria: Does the patient have comorbidities, organ function, or performance status, which will limit or not limit that patient from getting this therapy? If they get sick from cytokine release syndrome [CRS] or neurotoxicity, are they going to be able to get through it knowing that most of these side effects are reversible? The next set of criteria for screening and eligibility is to see if the patient is reliable, has a caregiver, can live close to the center where CAR T therapy is being offered, and is pretty gung-ho about this therapy, because it’s a significant investment and serious therapy. It would be very important to evaluate that. It’s important for the clinical team to not just work with the patient but also have a social worker, advanced providers, nurses, and nurse coordinators—a team approach to see not just if this person is eligible but if it is situationally feasible to do the CAR T therapy in them.

It’s also important to consider the disease status of the patient. This is a therapy for relapse and refractory disease. It’s important at the time of consolation to evaluate the pace of the disease. If someone is having a disease, which doesn’t appear to be controlled in the next few weeks—the time it takes to receive the CAR T therapy—then that person may not be feasible to get the CAR T therapy, as opposed to someone whose disease can be controlled with a bridging therapy between the time of consolation and application.

The timing for the CAR T infusion process depends on when the product is available. Once the product is available, most of the patients who are ready for the CAR T infusion process would have already finished lymphodepleting chemotherapy several days prior to receiving the CAR T product. At this point in time, the product from Kite Pharma, the axicabtagene ciloleucel [axi-cel] CTL019 [Kymriah], is infused at bedside. The product from Juno Therapeutics, which is currently on clinical trial, comes in vials. There are CD4 and CD8 vials. The correct amounts are drawn into syringes, and both of these products are individually administered to the patient after time. Those are the little differences between the lisocabtagene maraleucel CTL019 and axi-cel. What is most important is the outcome and the monitoring needed after CRS and neurotoxicity. How do you identify these toxicities early on? How do you intervene in order to prevent more severe toxicitie

Transcript Edited for Clarity 
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Transcript: 

Nilanjan Ghosh, MD, PhD: At this time, most of the sites that are offering CAR T therapy are academic site, which do stem-cell transplantation. If we think of the future and look to expand to community sites, which will obviously increase the access to patients to get CAR T therapy, we have to be mindful about maintaining the same set of criteria and guidelines, which we have used so far, so that the quality of collection as well as administration and patient toxicity management remains the same, irrespective of the site. We obviously should have the same standards for academic and community settings, but I think that if community sites are able to—knowing the details of what is entailed in offering CAR T therapies—then it’s a significant investment, which can certainly be done.

The first step in offering CAR T therapy is to find if a patient is eligible or not. The way to do that is to ignore the disease that the patient has in the FDA-approved indication. Relapsed and refractory diffuse large B-cell lymphoma, transformed follicular lymphoma, or primary mediastinal B-cell lymphoma after failure of 2 prior therapies. The next part of the process is to see if they meet this criteria: Does the patient have comorbidities, organ function, or performance status, which will limit or not limit that patient from getting this therapy? If they get sick from cytokine release syndrome [CRS] or neurotoxicity, are they going to be able to get through it knowing that most of these side effects are reversible? The next set of criteria for screening and eligibility is to see if the patient is reliable, has a caregiver, can live close to the center where CAR T therapy is being offered, and is pretty gung-ho about this therapy, because it’s a significant investment and serious therapy. It would be very important to evaluate that. It’s important for the clinical team to not just work with the patient but also have a social worker, advanced providers, nurses, and nurse coordinators—a team approach to see not just if this person is eligible but if it is situationally feasible to do the CAR T therapy in them.

It’s also important to consider the disease status of the patient. This is a therapy for relapse and refractory disease. It’s important at the time of consolation to evaluate the pace of the disease. If someone is having a disease, which doesn’t appear to be controlled in the next few weeks—the time it takes to receive the CAR T therapy—then that person may not be feasible to get the CAR T therapy, as opposed to someone whose disease can be controlled with a bridging therapy between the time of consolation and application.

The timing for the CAR T infusion process depends on when the product is available. Once the product is available, most of the patients who are ready for the CAR T infusion process would have already finished lymphodepleting chemotherapy several days prior to receiving the CAR T product. At this point in time, the product from Kite Pharma, the axicabtagene ciloleucel [axi-cel] CTL019 [Kymriah], is infused at bedside. The product from Juno Therapeutics, which is currently on clinical trial, comes in vials. There are CD4 and CD8 vials. The correct amounts are drawn into syringes, and both of these products are individually administered to the patient after time. Those are the little differences between the lisocabtagene maraleucel CTL019 and axi-cel. What is most important is the outcome and the monitoring needed after CRS and neurotoxicity. How do you identify these toxicities early on? How do you intervene in order to prevent more severe toxicitie

Transcript Edited for Clarity 
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