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

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

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 all therapies with known clinical benefit; patients must have received at least 2 prior anti-myeloma therapies which must contain at least one proteasome inhibitor (PI), one immunomodulatory drug (IMiD), and one anti-CD38 monoclonal antibody (if available).

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.

Conditions2

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