eligibility_summary
Eligible: adults 18–70 with refractory/relapsed multiple myeloma lacking effective options, KPS>50%, life expectancy >12 weeks, adequate liver function (ALT/AST<3× ULN, bilirubin<2 mg/dL), no serious heart/liver/kidney disease, relapse or failure after HSCT/cell therapy or transplant-ineligible, leukapheresis feasible, consented. Exclude: pregnancy, HIV/TB, active HBV/HCV, poor T-cell transfection/amplification, unstable vitals/psychiatric, severe allergy (incl. IL-2), serious infection, severe autoimmune disease, or other concerns.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: APRIL-BAFF-Bicephali CAR-T cells—an autologous, lentiviral-engineered, ligand-based dual-target chimeric antigen receptor T-cell therapy. Mechanism: Patient CD3+ T cells are modified to express a bicephalic binding domain composed of APRIL and BAFF ligands, enabling simultaneous recognition of receptors in the APRIL/BAFF axis on myeloma cells. Engagement triggers T-cell activation and cytotoxicity, aiming to reduce antigen escape versus single-target CARs. Targets (cells/pathways): Malignant plasma cells expressing TNF receptor family members—primarily BCMA (TNFRSF17) and TACI (TNFRSF13B), with possible BAFF-R—key mediators of APRIL/BAFF-driven survival (NF-κB signaling). Lymphodepletion (fludarabine/cyclophosphamide) is used to enhance CAR-T expansion.