eligibility_summary
Eligible: ≥14 yrs, WHO-diagnosed B-ALL, relapsed/refractory (not isolated extramedullary), CD19+, ECOG ≤2, survival >3 mo, adequate organs (LVEF ≥50%, normal O2 sat, TBil/AST/ALT ≤3×ULN, creat ≤1.5×ULN), negative pregnancy test, contraception for 1 yr, consent, no hereditary disease. Exclude: severe autoimmune/immunodeficiency, serious CNS or unstable CV disease/events, active GVHD, anti‑FMC63/positive DSA, recent CAR‑T/DLI, other active malignancy, uncontrolled comorbidities/infections, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: QH10304-BAL-01, an allogeneic CD19-directed CAR-γδ T cell therapy (cellular immunotherapy). Mechanism: γδ T cells are engineered with a CD19 CAR (FMC63 scFv) to recognize CD19 on B-lineage blasts, CAR signaling drives antigen-specific, largely MHC-independent cytotoxicity (perforin/granzyme) and cytokine release against CD19+ leukemia. Conditioning drugs: fludarabine (antimetabolite, purine analog) and cyclophosphamide (alkylating agent) for lymphodepletion to reduce host immunity and support CAR expansion/persistence. Targets: CD19 antigen on malignant B cells in relapsed/refractory B-ALL, lymphodepletion targets host lymphocytes. Early Phase 1, dose-escalation (3+3).