eligibility_summary
Adults with measurable multiple myeloma. Part A: ≥3 prior lines, relapsed/refractory/intolerant, prior anti-GPRC5D/anti-BCMA allowed. Part B: ≥3 lines and R/R or intolerant to IMiD, PI, anti‑CD38 mAb, and anti‑BCMA, prior anti‑GPRC5D not allowed. Key exclusions: ECOG ≥2, AL amyloidosis, POEMS, active plasma cell leukemia, CNS/meningeal MM, systemic therapy <14 d, NK‑engager <90 d, inadequate organ/marrow, major comorbidities. Contraception per local rules.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: First-in-human, Phase 1, subcutaneous SAR446523 in relapsed/refractory multiple myeloma. Drug/intervention and mechanism: SAR446523 is an ADCC-enhanced monoclonal antibody (likely IgG) targeting GPRC5D, Fc engineering boosts engagement of Fcγ receptors (e.g., CD16) on effector cells to drive antibody-dependent cellular cytotoxicity. Cells/pathways targeted: GPRC5D on malignant plasma cells, activation of NK cells (primary) via FcγRIIIa signaling to mediate cytotoxicity, potential contribution from other FcγR-expressing innate cells (e.g., macrophages).