A Study of CM336 in Patients With Relapsed or Refractory Multiple Myeloma

Last updated: October 14, 2024
Sponsor: Keymed Biosciences Co.Ltd
Overall Status: Active - Recruiting

Phase

1/2

Condition

Bone Neoplasm

Leukemia

Lymphoproliferative Disorders

Treatment

CM336_group 4b

CM336_RP2D

CM336_group 9

Clinical Study ID

NCT05299424
CM336-021001
  • Ages > 18
  • All Genders

Study Summary

This is a multi-center, open-label, Phase 1/2 study in China to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of CM336 in patients with relapsed or refractory multiple myeloma.

This study consists of a dose escalation part (Phase 1) and a dose extension part (Phase 2 ).

The safety and tolerability of CM336 will be evaluated in Phase 1 study, as well as the maximum tolerated dose (MTD) and the recommended dose level for Phase 2 study will be determined.

The efficacy of CM336 will be evaluated in Phase 2 study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.

  • Patients with relapsed or refractory MM who have failed or are intolerant to alltherapies with known clinical benefit; patients must have received at least 2 prioranti-myeloma therapies which must contain at least one proteasome inhibitor (PI),one immunomodulatory drug (IMiD), and one anti-CD38 monoclonal antibody (ifavailable).

Exclusion

Exclusion Criteria:

  • Patients who had received BCMA-targeted therapy.

  • Patients who had received CAR-T therapy.

  • Patients who had received anti-tumor therapy within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of CM336.

Study Design

Total Participants: 48
Treatment Group(s): 15
Primary Treatment: CM336_group 4b
Phase: 1/2
Study Start date:
August 09, 2022
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Peking University Third Hospital

    Beijing, Beijing
    China

    Active - Recruiting

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