Anbalcabtagene autoleucel (PD-1 and TIGIT knockdown CD19 CAR T-cell therapy) for relapsed or refractory LBCL: the CRC01-01 trial.
Won Seog Kim, Seok Jin Kim, Dok Hyun Yoon et al.
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In 30 seconds
The multicenter phase 1/2 CRC01-01 trial evaluated anbalcabtagene autoleucel, a CD19 CAR T-cell therapy with PD-1 and TIGIT knockdown, in patients with relapsed or refractory large B-cell lymphoma. In phase 2, 79 patients received treatment and efficacy was assessed in 73. The complete response rate was 67.1%, with a further 8.2% achieving partial response. Median progression-free survival was 6.04 months (95% confidence interval, 4.34-16.46). Grade ≥3 adverse events occurred in 97.5% of patients.
Key findings
- Among 73 patients assessed for efficacy, 67.1% achieved complete response and 8.2% partial response.
- Median progression-free survival was 6.04 months (95% confidence interval, 4.34-16.46); median overall survival was not reached.
- Grade ≥3 adverse events occurred in 97.5%; serious infections occurred in 25.3%, including grade 5 infection in 3 patients.
- Cytokine release syndrome occurred in 57.0%, with grade 3 events in 8.9% and no grade 4 events reported.
Why it matters
The response findings indicate substantial antitumor activity in this relapsed or refractory lymphoma population, while the high frequency of severe adverse events and serious infections underscores the treatment burden. The reported survival outcomes and response durability measures provide useful context for assessing this investigational CAR T-cell approach, but the abstract does not establish comparative benefit over other therapies.
What to keep in mind
The abstract reports a phase 1/2 study without a comparator, and efficacy was evaluated in 73 of the 79 phase 2 patients who received treatment.