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

Phase 1

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: CM336_group 1; Drug: CM336_RP2D; Drug: CM336_group 2a; Drug: CM336_group 2b; Drug: CM336_group 3a; Drug: CM336_group 3b; Drug: CM336_group 4a; Drug: CM336_group 4b; Drug: CM336_group 5; Drug: CM336_group 6a; Drug: CM336_group 6b; Drug: CM336_group 7; Drug: CM336_group 8a; Drug: CM336_group 8b; Drug: CM336_group 9

• Registration Number: NCT05299424
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-17
• Study First Submitted QC: 2022-03-18
• Study First Posted: 2022-03-29
• Study Start: 2022-08-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-15
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1, Dose escalation	CM336_group 1	There are 14 dose groups in dose escalation part ( Phase 1 study).
Phase 1, Dose escalation	CM336_group 2a	There are 14 dose groups in dose escalation part ( Phase 1 study).
Phase 1, Dose escalation	CM336_group 2b	There are 14 dose groups in dose escalation part ( Phase 1 study).
Phase 1, Dose escalation	CM336_group 3a	There are 14 dose groups in dose escalation part ( Phase 1 study).
Phase 1, Dose escalation	CM336_group 3b	There are 14 dose groups in dose escalation part ( Phase 1 study).
Phase 1, Dose escalation	CM336_group 4a	There are 14 dose groups in dose escalation part ( Phase 1 study).
Phase 1, Dose escalation	CM336_group 4b	There are 14 dose groups in dose escalation part ( Phase 1 study).
Phase 1, Dose escalation	CM336_group 5	There are 14 dose groups in dose escalation part ( Phase 1 study).
Phase 1, Dose escalation	CM336_group 6a	There are 14 dose groups in dose escalation part ( Phase 1 study).
Phase 1, Dose escalation	CM336_group 6b	There are 14 dose groups in dose escalation part ( Phase 1 study).
Phase 1, Dose escalation	CM336_group 7	There are 14 dose groups in dose escalation part ( Phase 1 study).
Phase 1, Dose escalation	CM336_group 8a	There are 14 dose groups in dose escalation part ( Phase 1 study).
Phase 1, Dose escalation	CM336_group 8b	There are 14 dose groups in dose escalation part ( Phase 1 study).
Phase 1, Dose escalation	CM336_group 9	There are 14 dose groups in dose escalation part ( Phase 1 study).
Phase 2, Dose expansion	CM336_RP2D	Based on the data of phase 1, the dose level recommended for the phase 2 study (RP2D) will be evaluated.

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicities (DLTs)	21 days after the first dose	Dose-limiting toxicities (DLTs)
Adverse events (AEs)	Up to 4.5 years	Adverse events (AEs), including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Overall Response Rate (ORR)	up to 4.5 years	Assessed according to International Myeloma Working Group (IMWG) response criteria.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China