eligibility_summary
Inclusion: R/R multiple myeloma (IMWG), ECOG 0–2, survival >12 wks, marrow GPRC5D >20%, measurable disease (M‑protein/sFLC criteria or ≥5% clonal plasma cells), and ≥3 prior lines incl IMiD, PI, anti‑CD38 with failure/relapse. Exclusion: smoldering or extramedullary‑only MM, plasma cell leukemia, amyloidosis, CNS disease, active HBV/HCV/HIV/syphilis/CMV, hypersensitivity, prior GPRC5D therapy, ASCT <8 wks, allogeneic SCT, major surgery <28 d, uncontrolled infection, pregnancy/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: OriCAR-017, an autologous GPRC5D-directed chimeric antigen receptor T-cell (CAR-T) therapy (biological, gene-modified cell therapy). Mechanism: patient T cells are engineered to express a CAR that recognizes GPRC5D on myeloma cells, CAR engagement activates T-cell signaling domains to drive T-cell activation, proliferation, cytokine release, and cytotoxic killing of target cells. Targets: GPRC5D on malignant plasma cells in relapsed/refractory multiple myeloma (requires ≥20% GPRC5D expression in bone marrow plasma cells). Study: Phase I/II, open-label, single-arm dose escalation/expansion to establish RP2D and assess safety, pharmacokinetics, and efficacy.