eligibility_summary
Eligible: CD19+ B‑ALL relapse—post‑alloHSCT or R/R after frontline + ≥2 rescues incl CD19/CD22 mAb—with matched related donor, CD19+ ≥50/µL or MRD ≥10^-4, consent, KPS/Lansky ≥60, contraception, negative pregnancy test. Exclude: pregnancy/lactation, uncontrolled infection, HIV/active HBV/HCV, life expectancy <6 wks, major liver/renal/cardiac/resp dysfunction, CHF/arrhythmia/noncompliance, active grade 2–4 GVHD, relapse <60 d post‑alloHSCT, recent steroids/chemo/IS/ATG/Alemtuzumab/radiation/investigational tx (IT chemo ok, physiologic steroids ok). Donors: standard allogeneic.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CD19-CAR_Lenti_ALLO—fresh, donor-derived, second-generation CD19-directed CAR T cells (gene-modified cellular immunotherapy, lentiviral-transduced). Mechanism: engineered T cells express a CAR with CD3ζ plus a costimulatory domain to recognize CD19 on B cells, triggering T-cell activation, proliferation, and cytotoxic killing, expected on‑target B‑cell aplasia. Conditioning: fludarabine (antimetabolite, lymphodepleting) and cyclophosphamide (alkylating agent) given pre-infusion to deplete host lymphocytes and enhance CAR T expansion. Targets: CD19 antigen on malignant B-cell precursor ALL blasts (and normal B cells), pathways engaged include CAR-mediated CD3ζ/T-cell activation with costimulation, lymphodepletion targets proliferating lymphocytes.