CM336 Plus Daratumumab and Lenalidomide in Transplant-Ineligible Newly Diagnosed Multiple Myeloma

Summary

The goal of this clinical trial is to evaluate whether CM336, a BCMA/CD3 bispecific antibody, in combination with daratumumab and lenalidomide can induce deep and durable responses in adults with transplant-ineligible newly diagnosed multiple myeloma (NDMM). The study will also evaluate the safety of this treatment combination. The main questions it aims to answer are: * How many participants achieve minimal residual disease (MRD) negativity after 6 treatment cycles? * What side effects occur during treatment with CM336 combined with daratumumab and lenalidomide? * How many participants respond to treatment and how deep are these responses? * How long does MRD negativity and treatment response last? * How long do participants remain free from disease progression? All participants will receive the study treatment. There is no comparison group in this study. Participants will: * Receive CM336 by subcutaneous injection together with subcutaneous daratumumab and oral lenalidomide in 28-day treatment cycles. * Undergo regular blood tests, bone marrow examinations, MRD assessments, and disease assessments to monitor treatment response and safety. * Be monitored throughout the study for treatment-related adverse events.

Timeline

Start

2026-10-15

Primary completion

2029-04-15

Completion

2031-04-30

Drugs

Indications