Tandem Meetings 2023 | Interim analysis of Phase II study of zamto-cel in R/R DLBCL

One of the oral presentations at the TCT meeting scheduled for later today is going to be looking at zamtocabtagene autoleucel. This is a bispecific CAR T-cell product targeting both CD19 and CD20. This is based upon the work that our group did at the Medical College of Wisconsin, which has now become a larger Phase II multi-center study. It uses the Prodigy CliniMACS, which is the same system that we used, but now using a homogenous population. So we’re looking specifically at third-line diffuse large B-cell lymphoma.

What’s unique about this program, however, is that we are specifically doing a fresh infusion, and so the T cells are collected at a local site, they’re shipped to a third-party manufacturing site, patients start lymphodepletion during the manufacturing process to facilitate a fresh infusion. We’re going to present a pre-specified interim analysis after 22 patients were treated. Basically, that shows that we met our threshold to continue the study.

The overall response rate for all of the patients was 78% versus 82% looking by the different sort of groups evaluating whether it’s [inaudible], so very nice response rate. And the six-month progression-free survival was above 60%, whether we looked at the evaluable set or all treated patients. From a toxicity standpoint, there was no grade 3 to 4 CRS and there was limited grade 3 ICANS, all of which was reversible.

This is the interim analysis. I think the data look exciting. Obviously the trial needs to complete its accrual and we need to get the final results with longer follow up, but I think this is the first study of a bispecific CAR as a multi-center trial in the United States for relapsed/refractory large cell lymphoma, and we’ve demonstrated the ability to manufacture it, to safely infuse it, and to do it using a fresh-in, fresh-out manufacturing paradigm.