Study of CM336 in Relapsed or Refractory Multiple Myeloma Patients

NCT ID: NCT07181239

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2030-04-30

Brief Summary

The purpose of this study is to compare the efficacy between CM336 and investigator's choice Standard of Care in relapsed or refractory multiple myeloma (RRMM) patients.

Conditions

Multiple Myeloma (MM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: CM336

Group Type: EXPERIMENTAL

CM336 Injection

Intervention Type: DRUG

Specified dose on specified days

Arm B: Standard of Care Regimens

Group Type: ACTIVE_COMPARATOR

Standard Of Care( SOC)

Intervention Type: DRUG

Specified dose on specified days

Interventions

CM336 Injection

Specified dose on specified days

Intervention Type: DRUG

Standard Of Care( SOC)

Specified dose on specified days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The subjects voluntarily sign the informed consent form (ICF) and agree to abide by the provisions of this protocol.
• Age ≥ 18 years old, gender is not limited.
• Eastern Cooperative Oncology Group performance status score (ECOG) 0-2 points.
• Patients with relapsed or refractory multiple myeloma who have received at least two lines of anti-myeloma treatment previously, and must include at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-Cluster of Differentiation 38(CD38) monoclonal antibody.
• The subject has evidence of disease progression or has not achieved remission after the last line of treatment, as determined by the investigator based on the International Myeloma Working Group (2016) criteria.
• The subject has measurable disease at the screening period, meeting at least one of the following criteria:

1. Serum M protein ≥ 5 g/L;

2. Urinary M protein ≥ 200 mg/24 h;

3. Serum free light chain (sFLC) ≥ 100 mg/L and abnormal κ/ λ ratio.

Exclusion Criteria

• Previous receipt of any treatment targeting B-cell maturation antigen (BCMA).
• Those who are intolerant to dexamethasone will be excluded.
• Within 3 months prior to the first administration, they have received chimeric antigen receptor T cells (CAR-T) /chimeric antigen receptor Nature killer cell (CAR-NK) therapy.
• Within 3 months prior to the first administration, they have received autologous stem cell transplantation; within 6 months prior to the first administration, they have received allogeneic stem cell transplantation (for subjects who have received allogeneic transplantation, they must have discontinued all immunosuppressants for ≥ 6 weeks and have no signs of graft-versus-host disease before being eligible for enrollment).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keymed Biosciences Co.Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lugui Qiu

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences

Gang An

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences

Locations

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Central Contacts

Qian Jia

Role: CONTACT

qianjia@keymedbio.com

86+028-88610620

Facility Contacts

Gang An

Role: primary

angang@ihcams.ac.cn

86+13502181109

Other Identifiers

CM336-021209

Identifier Type: -

Identifier Source: org_study_id