eligibility_summary
Eligibility: Age 0–60 with CD19+ B‑ALL (relapsed/refractory, post‑allo ≥3 mo and off IS allowed) or refractory B‑cell lymphoma (DLBCL/PMBCL/tFL/other) after ≥2 prior regimens incl. intensive, or relapse ≤12 mo after auto‑SCT. ECOG ≤2 (>16) or Lansky >50 (≤16), adequate organ function, negative pregnancy test. Exclude: active infection, GVHD/on IS, DLI <6 wks, autoimmune/CNS disease, HBV/HCV/HIV, poor pulmonary/cardiac/renal/liver function, rapidly progressive disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CUCART19, an autologous anti-CD19 CAR-T cell therapy (cellular gene therapy, adoptive immunotherapy). T cells are collected by leukapheresis, activated via CD3/CD28, and transduced with a self-inactivating lentiviral vector to express a CD19-specific chimeric antigen receptor, manufactured in a closed CliniMACS Prodigy system and infused after lymphodepleting chemotherapy. Mechanism of action: CAR binds CD19 on B-lineage cells, triggering T-cell activation and cytotoxicity (immune synapse formation, cytokine release, perforin/granzyme-mediated killing), eliminating CD19+ malignant cells and causing expected on-target B-cell aplasia. Targets: CD19 antigen on B-cell ALL and B-cell NHL (including DLBCL, PMBCL, transformed FL), pathways: T-cell receptor–independent CAR signaling (CD3ζ/co-stimulation), effector cytotoxic pathways.