Phase 2 Study of Subcutaneous BCMACD3 Bispecific Antibody CM336 for Adults Newly Diagnosed with Systemic Light Chain AL Amyloidosis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a low-dose BCMACD3 bispecific antibody called CM336 in patients who have been newly diagnosed with systemic light chain AL amyloidosis. This is a phase 2, single-center, single-arm clinical study designed to understand how well CM336 works and its safety profile in this specific patient group. Participants will receive CM336 as a subcutaneous injection once a week for up to 12 cycles, with an initial step-up dosing during the first week 3 mg on Day 1, 20 mg on Day 4, and 40 mg weekly from Day 8 onward. If a patient achieves a very good partial response or better after 4 cycles, the dosing frequency may be reduced to every two weeks starting from the fifth cycle. The study focuses on treatment and includes follow-up to assess both hematologic and organ responses. Throughout the study, participants will be monitored for their blood and organ responses, as well as any adverse events. Key measurements include the rate of hematologic very good partial response at 4 months, time to first hematologic response, duration of response, and overall survival up to approximately 36 months. Safety is closely followed from the first dose through 30 days after the last dose, with long-term follow-up for up to about 24 months. The total participation duration may span multiple months to allow for comprehensive assessment of treatment effects and safety.

BCMA/CD3 Bispecific Antibody Treatment for Newly Diagnosed Amyloidosis