eligibility_summary
Inclusion: adults 18-75 with MM (IMWG), relapsed/refractory after >=3 prior mechanisms, measurable M-protein or FLC criteria, ECOG 0-2, >3-mo survival, adequate organ function, recovered prior toxicities, consent/compliance. Exclusion: other aggressive cancers, recent therapy (<14 d/5 half-lives), CNS MM/disease, active HBV/HCV/HIV/syphilis, pregnancy, severe infection/bleeding, recent/planned ASCT, unstable cardiac/systemic disease, drug allergy, serious mental illness, substance abuse, GVHD, investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Anti‑GPRC5D CAR‑T cell therapy (autologous, gene‑modified T lymphocytes expressing a chimeric antigen receptor targeting GPRC5D), given after lymphodepleting chemotherapy (fludarabine + cyclophosphamide). Phase I/II, single‑arm, 3+3 dose escalation (3.0×10^6/kg, 6.0×10^6/kg, 1.0×10^7/kg). Mechanism of action: CAR binding to GPRC5D on myeloma cells activates T‑cell signaling, expansion, and cytotoxic killing (perforin/granzyme and cytokine‑mediated). Targets: GPRC5D antigen on malignant plasma cells in relapsed/refractory multiple myeloma, uses patient T cells as effectors, lymphodepletion reduces host lymphocytes to support CAR‑T expansion.