eligibility_summary
Eligibility: Adults (>=18) with large B-cell lymphoma, relapsed/refractory after >=2 lines incl auto-HSCT and anthracycline+anti-CD20, PET+ and measurable disease, ECOG 0-1, adequate organs and leukapheresis access, CD19+ if prior anti-CD19, contraception for 1 year post Relma-cel. Exclude: primary CNS lymphoma, other active cancer, HBV/HCV/HIV/syphilis, active DVT/PE, uncontrolled infection, GVHD, serious CV/CNS disease, pregnant/nursing, recent therapy (no washout), prior CAR-T/GM T cells.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
- Intervention: Relmacabtagene autoleucel (relma‑cel, JWCAR029) — an autologous, gene‑modified cellular therapy (CD19‑directed CAR‑T). Single fixed dose: 1×10^8 CAR+ T cells. - Mechanism of action: Patient T cells are engineered ex vivo to express a chimeric antigen receptor that binds CD19 on B cells, CAR engagement triggers T‑cell activation, proliferation, cytokine release, and cytotoxic killing of CD19+ lymphoma cells, expected on‑target class effect includes B‑cell aplasia. - Cells/pathways targeted: CD19‑positive malignant B cells in large B‑cell lymphoma, targets the CD19 surface antigen, activates T‑cell effector signaling via the CAR (immune synapse/TCR‑like activation pathways). - Study context: Open‑label, single‑arm Phase 2 in R/R LBCL in China evaluating efficacy, safety, and PK.