eligibility_summary
Eligibility: 18–75, consent, MM (IMWG), BM GPRC5D >10%, refractory to ≥3 MOAs or relapsed ≤6 mo, measurable M‑protein or FLC, prior tox <Gr2, ECOG 0–2, survival >3 mo, adequate organs (ALT/AST ≤3×ULN, bili ≤1.5×, Cr ≤1.5× or CrCl ≥60, SpO2 ≥92%, LVEF ≥45%, no signif effusions), venous access. Exclude: other cancers, recent therapy, CNS MM, PCL/WM/POEMS/AL, HBV/HCV/HIV/CMV/syphilis, severe allergy, major cardiac/systemic disease, GVHD, neuro‑autoimmune/PRES, tumor emergencies, infection, recent surgery/live vaccine, severe psych, substance abuse, pregnancy/plan <2 y, investigator risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Early Phase 1, single-arm study in relapsed/refractory multiple myeloma testing anti-GPRC5D-CD19 CAR-T cells. Intervention/type: Biological cellular therapy—genetically engineered CAR-T cells infused IV at 1.0, 3.0, or 6.0×10^6 cells/kg after lymphodepletion with fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent). Mechanism of action: CAR-T cells are redirected to recognize GPRC5D and CD19, antigen engagement activates T-cell signaling, cytokine release, and perforin/granzyme-mediated cytotoxicity. Dual targeting is intended to improve tumor eradication and limit antigen escape by hitting GPRC5D+ plasma cells and CD19+ myeloma/precursor B-lineage cells. Targets/cells/pathways: GPRC5D on malignant plasma cells, CD19 on B cells/myeloma subclones, immune effector (CAR) signaling leading to tumor cell lysis.