eligibility_summary
Eligible: adults 18–75 with relapsed/refractory multiple myeloma post bortezomib/lenalidomide failure, measurable disease, BCMA & GPRC5D+, ECOG 0–2, life expectancy ≥12 wks, apheresis-eligible, contraception/neg preg, no chemo <4 wks or antibodies <2 wks. Exclude: organ dysfunction, significant heart/lung/neuro disease, CNS involvement, infection, autoimmune/immunodef., anticoagulation, steroids/vaccines/trials, HIV/HBV/HCV/syphilis, prior allo-HSCT, plasma cell leukemia.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06644443 (Phase I/IIa, single-arm, recruiting, China) in relapsed/refractory multiple myeloma. Intervention: Autologous dual-target BCMA-GPRC5D CAR-T cells (biological, gene-engineered T‑cell therapy), dosed at 2–5×10^6 CAR-T/kg. Mechanism of action: Patient T cells are engineered to express chimeric antigen receptors that bind BCMA (TNFRSF17) and GPRC5D on myeloma cells. Antigen engagement triggers CAR signaling (CD3ζ with costimulatory domains), activating T-cell cytotoxicity (perforin/granzyme) and cytokine release to kill malignant plasma cells. Rationale: Dual targeting aims to prevent antigen escape/relapse seen with BCMA-only CAR-T in BCMA-low/negative disease. Targets: Myeloma plasma cells in bone marrow expressing BCMA and GPRC5D, immune effector pathways include CAR-mediated T-cell activation and cytolytic granule pathways. Primary focus: Safety and efficacy in RRMM.