How did you become involved with cell therapy?
Dr. Frigault (MF): I started working with cell therapy back in medical school. I fell in love with the concept of a Frankenstein immune system that could do good. I continued this work throughout residency, fellowship and my postdoctoral training. I was ultimately hired to grow a cell therapy program here at MGH as all this was starting to emerge. The program has grown bigger every year. We’ve added all different types of patients.
How are you working with rheumatologists?
MF: Oncology took a lot from rheumatology (e.g., checkpoint inhibitors), and now it’s going in the reverse direction. Cell therapy is complicated from a regulatory and infrastructure standpoint. So when I saw the use of cell therapy in ARDs coming, I made a pitch to start doing cell therapy studies in collaboration with non-oncology primary investigators. Oncology is in a really good position to run multiple, highly complex studies with lots of patients. We are used to doing that. So if we can bring efficiencies to rheumatologists interested in running cell therapy trials too, I’m on board. I want to get them excited and invested, and I want to provide the support safety net they need to do this work. I’ve tried to make it like pushing an easy button.
Are you running any cell therapy trials in patients with autoimmune disease right now?
MF: Yes. We are currently running cell therapy trials for SLE, rheumatoid arthritis, multiple sclerosis, myasthenia gravis and pan-autoimmune conditions.
What kind of patients are good candidates for cell therapy? Are there any frank contraindications?
MF: The only real contraindication is renal failure (CrCl <30 mL/min), and even that is somewhat relative. This is due to the need to use fludarabine for lymphodepletion, and it’s renally cleared with the potential risk of neurotoxicity. Relative contraindications include active infections and chronic long-term steroid use (due to negative effects on the immune system). We try to get the steroid dose down as low as possible for a period of time because there’s some thought that they might impact overall efficacy from a cancer standpoint. Otherwise, patient optimization is key.
Can you walk us through the patient’s experience from start to finish? What’s involved in the process?
MF: The patient has a consult to fully understand the risks and benefits. There’s a teaching session with a nurse. A social worker speaks with the patient and their family to identify areas of need. Then, we file the paperwork for insurance approval. Once approved, some CAR-T cell therapies require the patient to stay within the area for a set amount of time. Accordingly, some insurance companies have also started to offer housing support for patients meeting certain criteria.
