eligibility_summary
Key eligibility: Adults 18–75 with ECOG 0–1, B-cell NHL expressing CD19 and/or CD20, ≥1 evaluable lesion (Lugano 2014), primary refractory or relapsed/refractory after ≥2 therapy lines, or LBCL/grade 3B FL/t‑iNHL relapsing ≤12 mo after first-line CR or after auto‑HSCT, life expectancy ≥3 mo, adequate labs, consent required. Exclude: inadequate washout, prior non‑CD19 autologous CAR‑T or gene therapy, any allogeneic therapy/HSCT, HBV/HCV/HIV+, severe DMSO/LUCAR‑G39D allergy, pregnant/lactating.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06395870: Phase I, open-label, single-arm trial of LUCAR-G39D, an autologous, gene-modified CAR-T cell therapy (biological) that dual-targets CD19 and CD20 in adults with relapsed/refractory B-cell non-Hodgkin lymphoma. Mechanism: patient T cells are engineered to express CARs recognizing CD19/CD20, leading to antigen-dependent T-cell activation, proliferation, cytokine release, and cytotoxic elimination of malignant B cells (with expected on-target B-cell aplasia). Single-dose infusion after lymphodepleting chemotherapy (cyclophosphamide—alkylating agent, fludarabine—purine analog) to reduce host lymphocytes and enhance CAR-T expansion. Targets/pathways: CD19 and CD20 on B cells, CAR-mediated T-cell activation pathways.