Manali Kamdar, MD, MBBS, discusses the efficacy and tolerability of a phase 1 clinical trial testing a novel anti-CD19 chimeric antigen receptor T-cell product in adults with relapsed/refractory B-cell lymphoma.
Manali Kamdar, MD, MBBS, assistant professor of medicine-hematology and clinical director of lymphoma services at the University of Colorado Medicine, discusses the efficacy and tolerability of a phase 1 clinical trial testing a novel anti-CD19 chimeric antigen receptor (CAR) T-cell product in adults with relapsed/refractory (R/R) B-cell lymphoma (BCL).
The phase 1 trial investigated a new CD19-targeted CAR-T cell therapy in multiple subtypes of BCL, including marginal zone lymphoma, follicular lymphoma, transformed lymphoma and diffuse large BCL. One of the 7 patients treated with CAR T cells required a second apheresis.
At 90 days, 6 out of 7 patients had a complete metabolic response, one of whom had progressive disease at 180 days, while 5 maintained remission for more than 12 months. Flow cytometry showed peak CAR T-cell expansion at days 5 to 15, and cell persistence continued for these 5 patients up to day 180.
Kamdar says toxicity was manageable for this CAR T cell product, with 2 patients experiencing grade 2 cytokine release syndrome (CRS) and 1 patient experiencing grade 2 neurotoxicity. However, no grade 3 or higher toxicities were reported. Overall, this therapy showed high efficacy and tolerability, and the trial continues to enroll patients.
0:08 |With respect to toxicity, the safety profile was very manageable. Two patients experienced grade 2 CRS; 1 patient experienced grade 2 neurotoxicity. There were no grade 4, no grade 3, or 5 CRS or neurotoxicity that was reported. There were no new safety signals that were even detected. Flow cytometry was utilized to measure CAR T-cell expansion and persistence in 5 patients. We noticed that peak CAR T-cell expansion range from day 5 to day 15. Cell persistence was detected [in] 4 to 5 patients through at least day 180.
0:45 | In conclusion, 7 patients diagnosed with 5 different B-cell non-Hodgkin lymphoma subtypes have so far been treated with this CD19 CAR T-cell product. Manufacturing was successful for all patients. There were no safety related out of specifications and no new post-infusion safety signals that were detected….To date, 6 out of 7 patients remain alive, with 5 patients in complete metabolic response. Clearly, this phase 1 study looks very promising with its efficacy as well as safety profile. It continues to enroll, so we hope to present follow-up data at later meetings.