Inaticabtagene Autoleucel (CNCT19) in adult relapsed or refractory B-cell acute lymphoblastic leukemia

• Inati-cel can induce high and durable responses in r/r B-ALL patients with best ORR achieving 85.4% and median DOR being 20.7 months.

• At the median follow-up of 23.7 months, Inati-cel shown a manageable long-term safety profile and no new safety signal finding.

Prior to November 2023, CD19 CAR-T therapies had not been approved in China for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), leaving a significant unmet need. In response, Inaticabtagene Autoleucel (Inati-cel), a novel CD19 CAR-T therapy with a distinct scFv (HI19α), was developed and showed promising efficacy in preliminary clinical research. We conducted a phase 2, single-arm, multicenter study of Inati-cel in adult CD19+ r/r B-ALL in China. The primary endpoint was the overall remission rate (ORR) at the end of Month 3. Forty-eight patients who underwent Inati-cel infusion were evaluated for both efficacy and safety. Among them, thirty-four patients achieved and maintained remission beyond 3 months, with 3-month ORR of 70.8% (95%CI, 55.9-83.1). The best ORR was 85.4% with all responders reaching minimal residual disease (MRD) negativity. With median follow-up of 23.7 months, the median DOR was 20.7 months (95%CI, 6.4-not reached), and the median OS was not reached (95%CI, 13.0 months-not reached). Additionally, grade 3 or higher cytokine release syndrome and neurologic events occurred in 12.5% and 6.2% of patients respectively. The 2-year follow-up data suggest that Inati-cel demonstrated an encouraging and durable responses with manageable safety profiles in r/r B-ALL. Based on the data from this pivotal trial, Inati-cel was approved as the first CAR-T therapy for adult r/r B-ALL in China and underscores its potential therapeutic benefits for this patient population. NCT04684147