Study of CM336 in Relapsed or Refractory Multiple Myeloma Patients

NCT07181239 | Not Yet Recruiting Phase 3

• 1 other identifier: CM336-021209
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• PFS

  The progression-free survival (PFS) evaluated by Blinded Independent Central Review (BICR)

  Up to 4 years

Study Arms (2)

Arm A: CM336

EXPERIMENTAL

Drug: CM336 Injection

Arm B: Standard of Care Regimens

ACTIVE COMPARATOR

Drug: Standard Of Care( SOC)

Interventions

CM336 Injection DRUG

Specified dose on specified days

Arm A: CM336

Standard Of Care( SOC) DRUG

Specified dose on specified days

Arm B: Standard of Care Regimens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Serum M protein ≥ 5 g/L;
• Urinary M protein ≥ 200 mg/24 h;
• Serum free light chain (sFLC) ≥ 100 mg/L and abnormal κ/ λ ratio.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lugui Qiu

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Gang An

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Jia

CONTACT

86+028-88610620; qianjia@keymedbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): April 1, 2030
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

CN (1)