A Study of CM336 in Patients With Relapsed or Refractory Multiple Myeloma
ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKeymed Biosciences Co.Ltd
About this trial
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
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CM336_group 1
- CM336_group 2a
- CM336_group 2b
- CM336_group 3a
- CM336_group 3b
- CM336_group 4a
- CM336_group 4b
- CM336_group 5
- CM336_group 6a
- CM336_group 6b
- CM336_group 7
- CM336_group 8a
- CM336_group 8b
- CM336_group 9
- CM336_RP2D
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov