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NOT YET RECRUITING
NCT07830485
PHASE2

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

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

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.

Official title: A Prospective, Single-Arm, Single-Center, Phase II Study Evaluating the Safety and Efficacy of CM336 in Combination With Daratumumab and Lenalidomide in Transplant-Ineligible Newly Diagnosed Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-10-15

Completion Date

2031-04-30

Last Updated

2026-09-21

Healthy Volunteers

No

Interventions

DRUG

CM336 (BCMA/CD3 bispecific antibody)

CM336 is administered subcutaneously (SC) using a step-up dosing regimen of 3 mg on Day 1, 20 mg on Day 4, 80 mg on Day 7, and 160 mg on Day 10. The first administration of the target dose is considered Cycle 1 Day 1 of the target-dose phase. During Cycle 1, CM336 160 mg is administered once weekly. From Cycle 2 through Cycle 18, CM336 160 mg is administered every 4 weeks.

DRUG

Daratumumab

Daratumumab is administered subcutaneously at a dose of 1800 mg in 28-day treatment cycles. One dose is administered on Day 0 before initiation of the CM336 step-up dosing regimen. During the CM336 target-dose treatment phase, daratumumab is administered once weekly during Cycles 1-2, every 2 weeks during Cycles 3-6, and every 4 weeks during Cycles 7-18.

DRUG

Lenalidomide

Lenalidomide is administered orally at 25 mg once daily on Days 1-21 of each 28-day treatment cycle during Cycles 1-18. The starting dose may be adjusted for participants with renal impairment, frailty, or advanced age based on creatinine clearance and investigator judgment.

Locations (1)

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

Tianjin, Tianjin Municipality, China