An observational study evaluating the safety and efficacy of NexCAR19 (2nd generation Anti-CD19-4-1BB-CD3-zeta chimeric antigen receptor T-cell therapy) in adolescent and adult patients with relapsed/refractory B-cell malignancies

CAR T-cell therapy is a breakthrough innovation for relapsed/refractory B-cell malignancies and addresses an unmet medical need. Since these are rare diseases and the outcome in these conditions is dismal (median survival ~6 months) with conventional therapies, CAR T-cell therapies are approved via an accelerated approval pathway by the regulatory agencies globally. NexCAR19, the first indigenously developed CAR-T cell therapy for relapsed/refractory B-cell malignancies, received approval in India on October 12, 2023, based on our phase I/II data. Among the 53 patients evaluable at the time (38 with lymphoma, 15 with leukaemia) who underwent CAR-T cell infusion, the overall response rate was 70 % (37/53), with a 57% complete response (CR). In the lymphoma cohort, the response rate was 68% (26/38) with a 50 % CR (19/38), while in the leukaemia cohort, the overall response rate was 73% (11/15). Grade III CRS was seen in 5% of patients. Notably, none of the patients developed any grade of immune effector cell-associated neurotoxicity syndrome (ICANS).

We are conducting a study to assess the safety and efficacy of the product in the real-world population. Real world study is essential to comprehensively study the durability of the treatment response, as well as to monitor late-onset, uncommon, and unexpected adverse drug reactions in the real-world setting. Therefore, we plan to conduct a study to further elucidate the safety and efficacy profile of NexCAR19 in relapsed/refractory B-cell malignancies in a large cohort with a longer follow-up.