BCMA/CD3 Bispecific Antibody Treatment for Newly Diagnosed Amyloidosis

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

August 27, 2025

Primary Completion Date

December 1, 2026

Study Completion Date

December 1, 2027

Conditions
Systemic Light Chain Amyloidosis
Interventions
DRUG

anti-BCMA/CD3 bispecific antibody

CM336 is a bispecific T-cell engager targeting B-cell maturation antigen (BCMA) and CD3. In this study, CM336 is administered subcutaneously with a step-up dosing strategy in Cycle 1 (3 mg Day 1, 20 mg Day 4, 40 mg Day 8 and onwards weekly). Patients who achieve ≥VGPR by Cycle 4 may switch to 80 mg every two weeks from Cycle 5. The total treatment duration is up to 12 cycles (28 days per cycle), with follow-up for safety and efficacy endpoints including hematologic and organ response.

Trial Locations (1)

300000

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences, Tianjin

All Listed Sponsors
lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER