Nirav N. Shah, MD, discusses the safety of the lentiviral bispecific CAR T cells targeting CD20 and CD19 B-cell antigens, as well as future efforts from a phase 1/2 study of the product in patients with relapsed/refractory mantle cell lymphoma.
Nirav N. Shah, MD, associate professor, Medical College of Wisconsin, discusses the safety of the lentiviral bispecific CAR T cells targeting CD20 and CD19 B-cell antigens (LV20.19 CAR), as well as future efforts from a phase 1/2 study (NCT04186520) of the product in patients with relapsed/refractory mantle cell lymphoma (MCL).
At the 2023 Transplantation and Cellular Therapy Meetings, investigators presented data on the single-center, prospective study that examined 14 patients. The trial met its primary end point with an overall response rate (ORR) of 100% at day 28, including a 71% complete response (CR) rate. At day 90, the ORR remained at 100%, and the CR rate improved to 92%.
Regarding safety, findings for the use of LV20.19 CAR in patients with MCL have been in line with other histologies treated with the agent, Shah says. Thirteen of 14 patients (93%) experienced grade 1/2 cytokine release syndrome (CRS); however, there were no instances of grade 3/4 CRS. Two patients (14%) had grade 3/4 immune-effector cell-associated neurotoxicity syndrome (ICANS), and 1 patient (7%) had grade 1/2 ICANS.
Shah notes that no patients required intensive care unit–level care in the first 28 days; however, 1 non-relapse mortality was reported in a high-risk patient who previously received an allogeneic stem cell transplant for MCL, then subsequently relapsed and received CAR T-cell therapy, Shah explains. This patient died from gram-negative sepsis at day 46, Shah adds. Beyond the lone non-relapse mortality, LV20.19 CAR was well tolerated, and all patients remained alive at data cutoff, Shah continues.
The safety and efficacy profiles of this agent are favorable compared with currently available agents, Shah notes. Investigators next hope to evaluate LV20.19 CAR in patients with relapsed/refractory MCL in a multicenter setting, Shah concludes.