eligibility_summary
Ages 2–18 with relapsed/refractory CD19+ B-ALL and bone marrow disease, able to undergo apheresis, life expectancy >12 wks, Lansky/Karnofsky >50%, ≥7 days since chemo/steroids, consent, potential transplant donor. Excludes: other active cancer, chloroma/CNS infiltration or neuro symptoms, any CNS disorder, active GVHD, RT <14 d, prior anti-CD19/20, DLI/other cell therapy <30 d, severe infection, organ dysfunction.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: anti‑CD19 CAR T‑cell therapy (biological, autologous gene‑modified cell therapy). Mechanism: apheresis‑derived patient T cells are engineered to express a chimeric antigen receptor that binds CD19 on B cells, CAR engagement triggers T‑cell activation, expansion, cytokine release, and perforin/granzyme‑mediated cytotoxic killing of CD19+ cells, often leading to on‑target B‑cell aplasia. Targets: CD19 antigen on malignant B‑cell precursors in r/r B‑ALL, effector pathway is activated cytotoxic T‑lymphocyte signaling. Population: pediatric (2–18) r/r B‑ALL. Phase I/II single‑arm assessing safety/ORR, EFS, OS.