eligibility_summary
Adults >=18 with relapsed/refractory CD19+ B-cell NHL (DLBCL incl. variants, HGBCL incl. double/triple-hit, PMBCL, THRLBCL, transformed DLBCL, FL3b) after prior CD20 mAb+anthracycline (unless intolerant), ECOG 0-1, measurable disease, adequate organ function, life >=12 wks. Exclude active/primary CNS disease, prior CAR-T/allo-HSCT, recent chemo/radiation, active infections incl. HBV/HCV/HIV/CMV/syphilis, major cardiac or recent CVA/seizure/VTE, uncontrolled HTN, autoimmune/ILD, other cancers, recent live vaccine/other trials, pregnancy, contraception for 1 yr.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: MC-1-50, an autologous CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy (biological, gene-modified cellular therapy) made via the PrimeCAR platform (~3-day manufacturing) with a high T-naive cell fraction. Mechanism: patient T cells are engineered to express a CAR that binds CD19 on B cells, triggering antigen-dependent T-cell activation (via CD3ζ), proliferation, cytokine release, and perforin/granzyme-mediated cytotoxic killing, single IV infusion after lymphodepletion. Trial: Phase I, single-arm, dose-escalation (1–10×10^5 CAR+ cells/kg) in relapsed/refractory CD19+ B-cell NHL. Targets: CD19-expressing malignant B cells, on-target B-cell depletion, engagement of T-cell effector pathways and in vivo expansion/persistence.