eligibility_summary
Eligibility: Adults ≥18 with documented multiple myeloma (IMWG) and measurable disease (serum M-protein ≥1 g/dL, or urine M-protein ≥200 mg/24h, or involved serum free light chain ≥10 mg/dL with abnormal ratio), able and willing to follow study procedures. Exclusions: hypersensitivity to study drug, active plasma cell leukemia or systemic AL amyloidosis, or severe mental/medical conditions affecting compliance/consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1 single-arm study in relapsed/refractory multiple myeloma testing QLS32015, a humanized IgG1 bispecific antibody targeting GPRC5D and CD3. Administered subcutaneously in 21-day cycles with dose escalation/expansion. Mechanism: engages CD3 on T cells and GPRC5D on myeloma/plasma cells to form an immune synapse, activating T cells and redirecting cytotoxicity to kill GPRC5D-expressing malignant plasma cells. Primary aims: assess safety, tolerability, PK, immunogenicity, preliminary efficacy, and determine RP2D. Targets: CD3+ T cells and GPRC5D on myeloma cells, pathway: T-cell activation and tumor cell lysis.