eligibility_summary
Adults ≥18 with high‑risk smoldering multiple myeloma per Mayo 2018, IMWG 2020 (score ≥9), or evolving pattern, SMM per IMWG with BMPC 10–60%, M‑protein/FLC criteria, no MM‑related CRAB or lytic disease (≤1 MRI lesion), ECOG ≤2, adequate counts, liver/renal function, contraception required. Excludes symptomatic MM, other active cancers, prior BCMA therapy, recent SMM therapy, major cardiovascular/cerebrovascular disease, HIV, active HBV/HCV, pregnancy/lactation, GI issues, recent surgery/live vaccine.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Prospective, single-arm study in high‑risk smoldering multiple myeloma testing CM‑336, a subcutaneous BCMA/CD3 bispecific T‑cell engager (BiTE) antibody. Mechanism: CM‑336 binds BCMA (TNFRSF17) on malignant plasma cells and CD3 on endogenous T cells, creating an immunologic synapse that activates T‑cell cytotoxicity (perforin/granzyme) and cytokine release to eliminate BCMA+ plasma cells. Targets: BCMA‑expressing clonal plasma cells, CD3/TCR signaling on T cells. Dosing uses step‑up priming, then weekly/biweekly dosing with interval adjustments. Aim: evaluate safety and efficacy to prevent progression to symptomatic MM.