When Will CAR T-Cell Therapy Be an Option for CLL Patients?

Experts responded to listener questions during our January 13, 2023 virtual town hall. Watch the full webinar here.

Transcript:

Jeff Folloder:  The first question comes from Esther. She would like to know when will CAR T be a viable option for CLL patients, if ever? I’m going too tee that one up to you, Dr. Wierda.

Dr. Wierda: So, I’m optimistic that CAR T will eventually be a viable option as a standard of care. We’re not quite there yet. The trial that we have done that has completed enrollment is the trial called TRANSCEND. That was where we studied two different dose levels of liso-cel (lisocabtagene maraleucel), or the CD19 CAR T-cell, for patients with CLL with or without ibrutinib (Imbruvica). So that trial has completed and that trial results I believe will be submitted to the FDA for review for accelerated approval. They will need to do subsequently a confirmatory trial  that demonstrates clearly activity with the combination. And that process of submission, review, and approval is probably going to take a year or so.

So, I believe it’s coming but it’s a slow process, and it’s a process that requires collection of all the data, doing the follow-up, reviewing the data with the FDA, and identifying and addressing any safety concerns that may arise in the trials.