eligibility_summary
Eligibility: Consent, CD19+ relapsed/refractory B‑ALL (≥2 relapses, relapse ≥6 mo post‑allo‑HSCT, chemo‑refractory, Ph+ TKI‑failed, or marrow blasts ≥5%), ECOG 0–1, survival >12 wks, adequate renal/hepatic/pulmonary function, LVEF ≥45%, recovered from prior therapy, required drug washouts, contraception. Exclude: isolated EM relapse, Burkitt, CNS disease/prophylaxis, allo‑HSCT <6 mo, recent chemo/trial, active HBV/HCV/HIV/syphilis/infection, recent MI/unstable angina, pregnancy, neuroautoimmune, poor compliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Meta10-19, an autologous gene‑modified CD19 CAR‑T cell therapy (“metabolically armed”). Patients receive lymphodepletion with cyclophosphamide (DNA‑alkylating cross‑linker) and fludarabine (purine analog causing lymphocyte depletion) before a single Meta10‑19 infusion. Mechanism: CAR‑engineered T cells bind CD19 on B cells and trigger T‑cell activation and cytotoxic killing, the “metabolic arming” is intended to enhance CAR‑T metabolic fitness and persistence in vivo (reported elsewhere to include IL‑10 expression). Targets: CD19+ B‑ALL blasts (and normal CD19+ B cells), T‑cell activation/cytotoxic pathways (CAR/CD3ζ with costimulation, perforin–granzyme), and immunometabolic pathways supporting CAR‑T expansion and function.