NCT05299424

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

A Multi-center, Open-label, Phase 1/2 Clinical Study of CM336 Injection in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Keymed Biosciences Co.Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	CM336_group 1	CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 0.04mg of CM336 on the first day of first cycle (C1D1), 0.04mg on C1D8, 0.04mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUG	CM336_group 2a	CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 0.04mg of CM336 on the first day of first cycle (C1D1), 0.2mg on C1D8, 1.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUG	CM336_group 2b	CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 0.2mg of CM336 on the first day of first cycle (C1D1), 0.2mg on C1D8, 0.2mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUG	CM336_group 3a	CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 0.2mg of CM336 on the first day of first cycle (C1D1), 1.0mg on C1D8, 5.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUG	CM336_group 3b	CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 1.0mg of CM336 on the first day of first cycle (C1D1), 1.0mg on C1D8, 1.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUG	CM336_group 4a	CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 1.0mg of CM336 on the first day of first cycle (C1D1), 5.0mg on C1D8, 15.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUG	CM336_group 4b	CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 2.0mg of CM336 on the first day of first cycle (C1D1), 2.0mg on C1D8, 2.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUG	CM336_group 5	CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 2.0mg of CM336 on the first day of first cycle (C1D1), 8.0mg on C1D8, 24.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUG	CM336_group 6a	CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 2.0mg of CM336 on the first day of first cycle (C1D1), 10.0mg on C1D8, 40.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUG	CM336_group 6b	CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 3.0mg of CM336 on the first day of first cycle (C1D1), 3.0mg on C1D8, 3.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUG	CM336_group 7	CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 3.0mg of CM336 on the first day of first cycle (C1D1), 15.0mg on C1D8, 60.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUG	CM336_group 8a	CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 3.0mg of CM336 on the first day of first cycle (C1D1), 15.0mg on C1D8, 75.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUG	CM336_group 8b	CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 4.0mg of CM336 on the first day of first cycle (C1D1), 4.0mg on C1D8, 4.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUG	CM336_group 9	CM336 will be administered subcutaneously (SC) once a week (QW). Patients will take 4.0mg of CM336 on the first day of first cycle (C1D1), 20.0mg on C1D8, 90.0mg on C1D15 and subsequent treatment cycles until there is evidence of disease progression, unacceptable toxicity or other reasons for treatment discontinuation.
DRUG	CM336_RP2D	CM336 will be administered subcutaneously (SC) once a week (QW). Individual subjects may continue study treatment until disease progression/relapse, unacceptable toxicity, withdrawal of consent, receipt of other anti-MM therapies, death, loss to follow-up, or the end of study.

Timeline

• Start date: 2022-08-09
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-03-29
• Last updated: 2024-10-15

Locations

1 site across 1 country: China