eligibility_summary
Adults 18–75 with IMWG-defined multiple myeloma after ≥3 prior lines, measurable disease, ECOG 0–2, >3‑month survival, recovered (<grade 2) toxicities, adequate organ function, and venous access for leukapheresis. Exclude: recent anticancer therapy, other malignancy, CNS involvement, POEMS/AL, active HBV/HCV/HIV/CMV/syphilis, severe allergy, major cardiac/organ disease, GVHD, neuro autoimmune/cerebrovascular disease, emergencies/infection, recent surgery/live vaccine, psych/substance issues, pregnancy, or other high risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05749133 is a single-center, open-label, Phase 1/2, single-arm trial in relapsed/refractory multiple myeloma testing Anti-GPRC5D CAR-T Cells Injection (autologous chimeric antigen receptor T-cell therapy). Mechanism: patient T cells are engineered to express a CAR that binds GPRC5D on myeloma cells, CAR signaling (CD3ζ with costimulation) triggers T-cell activation, cytokine release, and cytotoxic killing of GPRC5D+ malignant plasma cells. Preconditioning uses lymphodepleting chemotherapy (fludarabine, a purine analog, and cyclophosphamide, an alkylator) to enhance CAR-T expansion. Dose: 3.0–6.0×10^6 CAR-T cells/kg IV. Targets: GPRC5D antigen on plasma cells and T-cell effector pathways.