eligibility_summary
Eligibility: Age 1-17 with relapsed/refractory CD19+ ALL or lymphoma after ≥2 lines, PS ≥50 (Karnofsky/Lansky), adequate organs (bili ≤3×ULN, AST/ALT ≤5×, creat ≤2×), Hb >8 g/dL, ALC >0.1×10^9/L, platelets >50×10^9/L, ≥2 weeks or 5 half-lives since last therapy, consent. Exclude: autotransplant <6 wks, prior nonprotocol CAR-T, active CNS disease, other active cancer, HIV, uncontrolled illness, pregnancy/breastfeeding, myelodysplasia, active hep B/C.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06866873 tests CHXCART01, an autologous CD19-directed CAR-T cell therapy (biological, gene‑modified cell therapy) in children with relapsed/refractory CD19+ ALL or B‑cell lymphoma. Intervention: single intravenous infusion of CAR‑T cells (0.2–2 million cells/kg) after lymphodepleting chemotherapy to promote CAR‑T expansion. Mechanism of action: patient T cells are engineered to express a chimeric antigen receptor that binds CD19 on B cells, triggering T‑cell activation, proliferation, and cytotoxic killing of CD19+ malignant cells, with expected on‑target B‑cell aplasia. Targets: CD19 on B‑lineage cells (normal and malignant), engages T‑cell effector pathways via CAR signaling to eradicate B‑cell leukemic/lymphoma cells.