eligibility_summary
Includes: informed consent, relapsed/refractory B-ALL with CD19/CD22 expression, adequate liver/kidney/lung/heart, life expectancy >3 months, contraception and no egg/sperm donation for 1 year after B019. Excludes: active CNS disease, isolated extramedullary relapse, recent >= grade 2 acute or moderate-severe chronic GVHD, prior CAR-T or prohibited therapy before PBMC/B019, other malignancy within 5 years, positive HBV/HCV/HIV/EBV/CMV/HTLV, investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 1, single-arm study in relapsed/refractory B‑cell acute lymphoblastic leukemia (China). Intervention: B019 injection — a biological cell therapy (CAR T cells) given IV at 1.0×10^6–10.0×10^6 CAR T cells/kg. Mechanism of action: Genetically engineered T cells expressing chimeric antigen receptors that recognize B‑cell antigens CD19 and CD22 (dual‑target). Upon antigen binding, CAR signaling activates T cells to proliferate and mediate cytotoxic killing of leukemic cells, aiming to reduce antigen‑escape seen with single‑antigen CARs. Targets (cells/pathways): Malignant B‑ALL blasts expressing CD19 and/or CD22, engages CAR signaling pathways (CD3ζ with costimulation) leading to T‑cell activation, cytokine release, and apoptosis of target B cells.