Nirav N. Shah, MD, discusses findings from a phase 1/2 study of lentiviral bispecific CAR T cells targeting CD20 and CD19 B-cell antigens in patients with relapsed or refractory mantle cell lymphoma.
Nirav N. Shah, MD, associate professor, Medical College of Wisconsin, discusses findings from a phase 1/2 study (NCT04186520) of lentiviral bispecific CAR T cells targeting CD20 and CD19 B-cell antigens (LV20.19 CAR) in patients with relapsed or refractory mantle cell lymphoma (MCL).
This single-center, prospective study was designed as a 14-patient, single-stage, phase 2 trial, with a target 3-month complete response (CR) rate of 50% based on the CR rate seen with ibrutinib (Imbruvica) in patients with relapsed/refractory MCL in the phase 2 PCYC-1104-CA trial (NCT01236391), Shah says. In PCYC-1104-CA, the overall response rate (ORR) was 68% with a CR rate of 21% in patients who received ibrutinib. This phase 1/2 study of LV20.19 CAR was designed to be positive if 6 or more patients achieved a CR by 90 days, Shah explains.
Patients enrolled to this trial had a median age of 63 years and a median of 5 prior lines of therapy. All patients had received a prior BTK inhibitor, and 11 patients had progressed on this therapy. Five patients had also progressed on the non-covalent BTK inhibitor pirtobrutinib (Jaypirca), which they received in a previous clinical trial.
The trial met its primary end point. At day 28, the ORR was 100%, with 71% of patients achieving a CR and 29% of patients achieving a partial response (PR), Shah emphasizes. In addition, of the 12 patients assessed for minimal residual disease (MRD), 9 were MRD negative between days 28 and 65 post-CAR T-cell therapy. At day 90, the ORR remained at 100%, with some patients converting from a PR to a CR, bringing the CR rate up to 92%, Shah says. In the phase 2 cohort, 8 patients have achieved a 90-day CR so far, Shah notes.
Additionally, at a median follow-up of 22 months, of the 14 patients treated with LV20.19 CAR, 1 patient had relapsed, Shah concludes.