CAR-T KITE-363's Safety Profile in R/R B-Cell Lymphoma

At the European Hematology Association (EHA) 2025 Congress, held June 12 to 15, both virtually and in Milan, Italy, data are being presented from a phase 1 clinical trial (NCT04989803) evaluating Kite's KITE-363, a dual CD19 and CD20-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of patients with relapsed/refractory (r/r) B-cell lymphoma. CGTLive®'s sister site, OncLive®, sat down with Saurabh Dahiya, MD, FACP, an associate professor of medicine at Stanford University School of Medicine and the clinical director of cancer cell therapy in the Division of Blood and Marrow Transplantation and Cell Therapy at Stanford Medicine, to learn more about the results.

Dahiya went over the key safety and efficacy findings presented. He noted that the study achieved its highest dose level without any dose-limiting toxicities (DLTs) and with regard to efficacy pointed out that a 78% complete remission rate was observed.

OncLive: Can you discuss the safety profile of KITE-363 in this trial?

Saurabh Dahiya, MD, FACP: The primary end point of this study was DLTs. We did not observe any DLT, and as such, we were able to reach the highest dose level. In terms of safety, at the highest dose level in CAR-naive patients, we did not see any grade 3, 4, or 5 cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome events in the intended patient population of large B-cell lymphoma that is r/r to first line or in third line setting.

Looking at efficacy, what kind of responses were seen in CAR-naive lymphoma?

At the highest dose level in CAR-naive patients, we observed an objective overall response rate of 87% and a complete remission rate of 78%.

What was the durability of responses like?

The durability of these responses appeared to be quite good, where the median duration of complete remission has not been reached just yet. The point estimate at 6 months was 72% in this high-risk patient population.

This transcript has been edited for clarity.

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