NCT06745687

BCMA/CD3 BsAb in the Treatment of High-risk Smoldering Multiple Myeloma

A Prospective, Multi-center, Single-arm Clinical Trial of BCMA/CD3 BsAb in the Treatment of High-risk Smoldering Multiple Myeloma

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of CM-336, which is a BCMA/CD3 BiTE, in the treatment of high risk smoldering multiple myeloma.

Detailed description

The purpose of this study is to evaluate the safety and efficacy of CM-336, which is a BCMA/CD3 BiTE, in the treatment of high risk smoldering multiple myeloma. High-risk SMM has a high risk of transforming to MM, and there is no unified treatment plan in clinical practice at present. Studies have proved that early treatment can help prevent end organ damage caused by disease progression and improve patient prognosis. The treatment of high-risk SMM needs to be further explored. BCMA/CD3 BITE in the treatment of RRMM shows a high remission rate and low toxicity and side effects, and it is expected to become a potential treatment choice for high-risk SMM patients

Conditions

• High Risk Smoldering Multiple Myeloma

Interventions

Type	Name	Description
DRUG	CM336	Patients received subcutaneous CM-336 80 mg once weekly in 28-d cycles after two step-up priming doses of 3 mg and 20 mg given on day 1 and day 4 of cycle 1 and cycle2. Then patients will be given 160mg every 2 weeks from cycle 3 to cycle 6. The dosing interval is adjusted according to the evaluation of efficacy every 6 cycles from cycle 7 to cycle 24.

Timeline

• Start date: 2024-12-30
• Primary completion: 2026-08-01
• Completion: 2028-08-01
• First posted: 2024-12-20
• Last updated: 2024-12-20

Locations

1 site across 1 country: China