Phase I study of META 10-19 in R/R B-cell ALL

Results from a single-arm, phase I study (NCT05747157), published by Xu et al. in The Lancet Hematology, assessed the safety and efficacy of META 10-19, an investigational chimeric antigen receptor (CAR) T-cell therapy expressing interleukin 10 (IL-10), in 12 Chinese patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). Patients received a single infusion of META 10-19 at either 0.1 × 10⁶ or 0.2 × 10⁶ CAR T cells/kg. The primary endpoints were safety and activity, and the median follow-up was 12.5 months.

Key data: Grade ≥3 adverse events (AEs) were predominantly hematological toxicities, experienced by 100% of patients, including neutropenia (100%), anemia (83%), and thrombocytopenia (83%). Grade 1–2 cytokine release syndrome (CRS) occurred in 92% of patients. No cases of immune effector cell-associated neurotoxicity syndrome (ICANS) or treatment-related deaths were reported. At 1 month, the overall response rate (ORR) was 100%, complete response (CR) was 33%, CR with incomplete or partial hematological recovery (CRi/CRh) was 42%, and the morphological leukemia-free state (MLFS) was 25%. 

Key learning: META 10-19 demonstrated tolerability and a manageable safety profile in patients with R/R B-ALL, supporting IL-10 engineering as a potential strategy to optimize CAR T-cell therapy.