eligibility_summary
Eligibility: Adults 18–75 with relapsed/refractory MM or plasma cell leukemia after ≥3 prior lines incl PI and IMiD, GPRC5D+ tumor, measurable disease (M‑protein/sFLC/marrow≥10% or extramedullary ≥2 cm), ECOG 0–2, life ≥12 wks, adequate blood, liver, renal, coagulation, SpO2>91%, LVEF≥50%, contraception, consent. Exclude: GVHD/immunosuppression, recent therapy/high‑dose steroids, uncontrolled HTN, serious cardiac/organ disease, other cancers, transplant, recent surgery/trial, active infection, HBV/HCV/HIV/CMV/syphilis+, pregnancy, CNS/psychiatric disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05759793 tests CAR-GPRC5D (RD118), an individualized, gene‑modified autologous CAR‑T cell therapy for relapsed/refractory multiple myeloma or plasma cell leukemia. Patient T cells are lentivirally engineered to express a CAR with a fully human single‑domain antibody (VHH) targeting GPRC5D and 4‑1BB (costimulatory) plus CD3ζ (activation) signaling domains. Mechanism: CAR‑T cells bind GPRC5D, become activated, expand, and kill GPRC5D‑expressing cells. Conditioning uses fludarabine and cyclophosphamide before a single infusion (1.0, 2.0, or 3.0×10^6 CAR‑T/kg). Targets: malignant plasma cells expressing GPRC5D (and potentially normal GPRC5D+ cells). Pathways: GPRC5D antigen recognition, T‑cell activation via 4‑1BB/CD3ζ.