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NCT Number: NCT07181239

Study of CM336 in Relapsed or Refractory Multiple Myeloma Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Location contact

Gang An

CONTACT

[email protected]

86+13502181109

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

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).

Treatment and study plan

CM336 Injection

Drug

Specified dose on specified days

Standard Of Care( SOC)

Drug

Specified dose on specified days

Primary outcomes

  1. PFS

    Time frame: Up to 4 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Jia

CONTACT

[email protected]

86+028-88610620

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

A Phase III, Randomized, Open-Label, Multicenter Study Comparing CM336 Monotherapy vs. Investigators Selected Standard of Care in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received ≥2 Prior Lines of Therapy

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Sep 18, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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