Anbal-cel shows responses in phase 2 trial for relapsed or refractory LBCL

Anbalcabtagene autoleucel (anbal-cel) is an investigational CD19-directed CAR T-cell therapy designed with PD-1 and TIGIT knockdown. The phase 1/2 CRC01-01 trial studied the treatment in patients with relapsed or refractory large B-cell lymphoma. In phase 2, 79 patients received anbal-cel, and efficacy was evaluated in 73.

The complete response rate was 67.1%, and the partial response rate was 8.2%. Median progression-free survival was 6.04 months (95% CI, 4.34–16.46); progression-free survival rates at 6, 12 and 18 months were 50.9%, 41.1% and 35.2%. Median overall survival was not reached; 12- and 18-month overall survival rates were 66.6% and 57.3%.

Grade 3 or higher adverse events occurred in 97.5% of patients, most commonly neutropenia (93.7%). Cytokine release syndrome occurred in 57.0%, including grade 3 events in 8.9%; 13.9% had neurological events, with grade 3 or higher events in 3.8%. Serious infections occurred in 25.3%, including three grade 5 infections. These phase 2 findings are from an investigational therapy and do not establish comparative benefit; the reported response and survival results should be considered alongside the substantial toxicity burden.