THE CLINICAL TRIAL
High-risk large B-cell lymphoma (LBCL) has poor outcomes with standard first-line chemoimmunotherapy. This phase 2, multicenter, single-arm clinical study we evaluated axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, as part of first-line treatment in 40 patients with high-risk LBCL. The primary objective was evaluate complete response rate (CRR). Secondary objectives were to evaluate objective response rate (ORR), duration of response (DOR), event-free survival (EFS), progression-free survival (PFS), overall survival (OS), assessment of safety, central nervous system (CNS) relapse and blood levels of CAR T cells and cytokines.