Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05299424

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

Led by Keymed Biosciences Co.Ltd · Updated on 2024-10-15

48

Participants Needed

1

Research Sites

225 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2
  • Patients with relapsed or refractory multiple myeloma who failed or are intolerant to all therapies with known clinical benefit
  • Patients must have received at least 2 prior anti-myeloma therapies including at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 monoclonal antibody if available
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking University Third Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

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Research Team

Q

Qian Jia

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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