Two-center phase 1 trial of C-CAR066 after failure of anti-CD19 CAR-T therapy for relapsed or refractory large B-cell lympoma
Managing large B-cell lymphoma (LBCL) that is refractory to or relapses after CAR-T therapy remains a significant challenge. A phase 1 trial at two centers in China evaluated the autologous anti-CD20 CAR-T C-CAR066 for relapsed or refractory LBCL after failure of anti-CD19 CAR-T therapy. Patients received a single intravenous infusion of C-CAR066 at a target dose of 2.0 x 106 or 3.0 x 106 C-CAR066 cells per kg. The primary endpoint was the incidence of adverse events (AEs). The most common AEs of grade 3 or higher were hematologic toxicities. Cytokine release syndrome was seen in 12 of 14 patients (grade 4 in one). No patients experienced ICANS. The overall response rate was 92.9%, with complete response in 57.1%. The median progression-free survival was 9,4 months (95% CI 2.0-NA) and the median overall survival was 34.8 months (7.5-NA). The authors conclude that C-CAR066 demonstrated a manageable safety profile and promising efficacy in R/R LBCL after failure of anti-CD19 CAR-T therapy.