eligibility_summary
Adults ≥18, ECOG 0–2 with R/R measurable NHL. Eligible: FL1–3a/MZL after ≥2 lines, DLBCL/PMBCL/HGBCL/FL3b after ≥2 lines or post‑auto‑SCT relapse/ineligible, MCL with progression/refractory and prior anthracycline/bendamustine, anti‑CD20, BTKi. Adequate marrow/organ function, contraception. To treat: no uncontrolled infection, no new therapy after apheresis. Exclude: recent therapy, chronic immunosuppression/GVHD, active CNS disease, major cardiac/vascular disease, pregnancy/lactation, Part B.2: prior CD19‑cell therapy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, single-arm, first-in-human study of autologous bivalent CD79b-19 CAR T cells for relapsed/refractory B-cell non-Hodgkin lymphomas (DLBCL, FL, MZL, PMBCL, HGBCL, MCL). Interventions: 1) CD79b-19 CAR T cells (cellular gene therapy). Patient T cells are engineered to express a CAR that binds CD79b (Igβ component of the B-cell receptor complex) and CD19, activating T-cell cytotoxicity and cytokine release to kill malignant B cells, dual targeting aims to limit antigen escape. Single IV infusion after leukapheresis. 2) Lymphodepletion with fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) to reduce host lymphocytes and enhance CAR T expansion/persistence. Targets: CD19 and CD79b on malignant B cells, B-cell receptor-associated antigen expression on tumor cells, CAR-mediated T-cell activation pathways.