eligibility_summary
Eligibility: ≤25y R/R CD19+ B‑ALL with BM blasts ≥5%, Ph+ after ≥2 TKIs or TKI-resistant/intolerant/contraindicated (t315i exempt). Adequate organ function, KPS≥70/Lansky≥50, apheresis access. Exclude: isolated extramedullary relapse, Burkitt, active CNS disease/leukemia, recent HSCT or GVHD, uncontrolled infection or active HBV/HCV/HIV/EBV/CMV, recent anticancer Rx/steroids/G‑CSF, prior CAR‑T, live vaccine, organ transplant, other active cancer, other trials, most genetic syndromes (Down ok).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CAR‑T‑19 cell injection, a gene‑modified cellular therapy using autologous T cells (or prior HSCT donor–derived T cells) engineered to express an anti‑CD19 chimeric antigen receptor. Mechanism: the CAR binds CD19 on B‑lineage cells and delivers activation/costimulatory (CD3ζ‑based) signals to drive T‑cell cytotoxicity (perforin/granzyme) and cytokine release, eradicating CD19+ leukemic blasts and inducing B‑cell aplasia. Pre‑infusion lymphodepletion with cyclophosphamide (alkylating DNA crosslinker) and fludarabine (purine analog) decreases host lymphocytes to enhance CAR‑T expansion. Targets: CD19 on B‑ALL, T‑cell effector pathways via CAR signaling.