Multicenter phase 1 studies of allogeneic CAR T cell products ALLO-501 or cema-cel for relapsed or refractory large B-cell lymphoma

Cemacabtagene ansegedleucel (cema-cel) and its predecessor ALLO-501 are off-the-shelf, allogeneic CD19 CAR T cell products derived from healthy donors. The multicenter phase 1 ALPHA2 and ALPHA trials in the USA evaluated cema-cel/ALLO-501 for CD19 CAR T-naïve patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) after a median of 3 prior therapies. After 3 days of lymphodepletion, patients received cema-cel/ALLO-501. CAR T cell expansion was observed following infusion, with persistence observed up to 4 monts. Overall and complete response rates were 58% and 42%, respectively. Median duration of response in patients with a complete response was 23.1 months. There were no cases of graft-versus-host disease, immune effector cell-associated neurotoxicity syndrome, or grade ≥ 3 cytokine release syndrome. The authors conclude that allogeneic CD19 CAR T cells demonstrated promising overall and durable complete response rates with a manageable safety profile in CD19 CAR T-naïve patients with R/R LBCL.