eligibility_summary
Eligible: Patients with IMWG-defined multiple myeloma, ≥3 prior regimens including a PI and an IMiD, progression during/within 12 months of last therapy, measurable disease, ECOG 0–1, life expectancy ≥12 weeks, and GPRC5D+ marrow plasma cells. Exclude: GVHD/immunosuppression, ASCT/allo-HSCT within 12 weeks, systemic steroids in prior 7 days/need long-term, uncontrolled hypertension (≥140/90), prior GPRC5D therapy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 1, single-arm, open-label (withdrawn) in relapsed/refractory multiple myeloma. Intervention: ICI201, a cellular immunotherapy (autologous, genetically modified CAR-T cell product). Mechanism of action: Patient T cells are engineered to express a chimeric antigen receptor with an anti-GPRC5D scFv, CAR engagement of GPRC5D triggers CD3ζ/co-stimulatory signaling, leading to T-cell activation, proliferation, cytokine release, and perforin/granzyme-mediated cytotoxic killing of target cells. Targets: GPRC5D-expressing malignant plasma cells, pathways involve CAR-mediated T-cell activation.