eligibility_summary
Eligibility: ≤75 yrs, B‑ALL, CD19+, ECOG ≤3, expected survival >3 mo, adequate organs (CrCl>30, EF≥40%, SpO2≥92%), labs: ALC ≥0.5×10^9/L, PLT>30×10^9/L, Hb>80, no CNS disease, uses contraception, consent. Exclude: pregnancy/lactation, HBV/HCV/HIV/syphilis/CMV+, other malignancy, prior anti‑CD19, auto‑HSCT <6 wks, active infection, allergy/autoimmune, GI bleed/ulcer, psych noncompliance, recent study drugs, ≥II GVHD, investigator decision.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06514768 (Early Phase 1, single-arm) tests JY231 Injection for CD19+ B‑cell acute lymphoblastic leukemia. Intervention: JY231 (biological, gene therapy/viral vector) dosed by transducing units and delivered IV, via splenic artery, or lymph node. Mechanism: in vivo transduction of patient immune cells to express an anti‑CD19 receptor (CAR-like), activating T‑cell signaling and cytotoxicity against CD19+ malignant B cells, potentially causing on‑target B‑cell aplasia. Preconditioning: fludarabine (purine analog lymphodepleter) and cyclophosphamide (alkylating agent) to reduce host lymphocytes and enhance expansion/persistence. Targets: CD19 on B cells, T‑cell activation pathways via CAR signaling.