eligibility_summary
Eligible: ages 2–70 with relapsed/refractory B‑cell leukemia, KPS >60, life expectancy >3 mo, CD19+ (IHC >15% or flow >30%), failed ≥1 standard therapy, adequate heart (LVEF ≥40%), lungs (SpO2 >94%), kidneys (Cr ≤133 μmol/L), no serious mental/autoimmune/immunodef. disease or other cancers, prior allo‑SCT allowed if ≥100 d, no active GVHD, off immunosupp. ≥30 d. Exclude: KPS <50, cytokine allergy, active infection, GVHD, T‑cell inhibitors, pregnant/nursing, HIV/HBV/HCV, or otherwise unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase I, single-arm study of autologous anti-CD19 CAR T cells for relapsed/refractory CD19+ B‑cell leukemia. Intervention/type: Biological, gene‑modified cellular immunotherapy (CD19 CAR‑T) given after lymphodepleting chemotherapy, dose escalation. Mechanism of action: Patient T cells are engineered to express a chimeric antigen receptor that binds CD19, activating T cells independently of MHC to proliferate and kill targets via cytotoxic effector functions and cytokine release, leading to depletion of CD19+ malignant (and normal) B cells. Targets: CD19 antigen on B‑lineage cells, T‑cell activation pathways via CAR signaling.