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

Keymed Biosciences

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: CM336_group 8a; Drug: CM336_group 6a; Drug: CM336_group 3b; Drug: CM336_group 5; Drug: CM336_group 8b; Drug: CM336_group 3a; Drug: CM336_group 6b; Drug: CM336_group 1; Drug: CM336_group 2b; Drug: CM336_RP2D; Drug: CM336_group 9; Drug: CM336_group 4a; Drug: CM336_group 7; Drug: CM336_group 4b; Drug: CM336_group 2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT05299424

CM336-021001

Details and patient eligibility

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Phase 1, Dose escalation

Experimental group

Description:

There are 14 dose groups in dose escalation part ( Phase 1 study).

Treatment:

Drug: CM336_group 2a

Drug: CM336_group 4b

Drug: CM336_group 7

Drug: CM336_group 4a

Drug: CM336_group 9

Drug: CM336_group 2b

Drug: CM336_group 6b

Drug: CM336_group 1

Drug: CM336_group 3a

Drug: CM336_group 8b

Drug: CM336_group 5

Drug: CM336_group 3b

Drug: CM336_group 6a

Drug: CM336_group 8a

Phase 2, Dose expansion

Experimental group

Description:

Based on the data of phase 1, the dose level recommended for the phase 2 study (RP2D) will be evaluated.

Treatment:

Drug: CM336_RP2D