eligibility_summary
Inclusion: 18–75, CD19+ relapsed/refractory B‑cell lymphoma (FL, MZL, DLBCL, PMBCL, TFL, TCRBCL) or B‑ALL (blasts >5%), measurable disease, ECOG 0–1, >12‑wk survival, adequate organ/bone marrow, no HSCT <6 mo, washouts for steroids, immunosuppressants, CD20, CNS prophylaxis, contraception. Exclusion: CNS involvement, recent study drugs/RT, prior anti‑CD19/CD3 or gene/CAR‑T, active HBV/HCV/HIV/syphilis, uncontrolled infection, MI/unstable angina, other cancer, arrhythmia, anticoagulation, neuro‑autoimmune, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests JY231 Injection, an in vivo CAR-T gene therapy vector (IV). Mechanism: the vector transduces the patient’s own T cells in vivo to express a CD19‑targeted chimeric antigen receptor, generating autologous CAR-T cells that recognize CD19 on malignant B cells, activate CAR signaling, and mediate cytotoxic killing and in vivo expansion. Target cells/pathways: CD19 antigen on B-cell malignancies (B-ALL, B-NHL) is the tumor target, autologous T lymphocytes are the transduction/effector cells, pathway involves CAR engagement (CD3ζ/costim-dependent activation) independent of native TCR. Preconditioning (supportive, not investigational): fludarabine (purine analog) and cyclophosphamide (alkylator) for lymphodepletion to enhance CAR-T expansion. Dose expressed in transduction units/kg.