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

Primary Purpose

Multiple Myeloma

Status

Not yet recruiting

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-1.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Phase 1, Dose escalation

Phase 2, Dose expansion

Arm Description

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

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

Outcomes

Primary Outcome Measures

Dose-limiting toxicities (DLTs)

Adverse events (AEs)

Adverse events (AEs), including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

Overall Response Rate (ORR)

Assessed according to International Myeloma Working Group (IMWG) response criteria.

Secondary Outcome Measures

Full Information

NCT ID

NCT05299424

First Posted

February 17, 2022

Last Updated

March 18, 2022

Sponsor

Keymed Biosciences Co.Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05299424

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 15, 2022 (Anticipated)

Primary Completion Date

December 2026 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Keymed Biosciences Co.Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Phase 1, Dose escalation

Arm Type

Experimental

Arm Description

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

Arm Title

Phase 2, Dose expansion

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

CM336_group 1

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CM336_group 2a

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CM336_group 2b

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CM336_group 3a

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CM336_group 3b

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CM336_group 4a

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CM336_group 4b

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CM336_group 5

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CM336_group 6a

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CM336_group 6b

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CM336_group 7

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CM336_group 8a

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CM336_group 8b

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CM336_group 9

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CM336_RP2D

Intervention Description

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.

Primary Outcome Measure Information:

Title

Dose-limiting toxicities (DLTs)

Description

Dose-limiting toxicities (DLTs)

Time Frame

21 days after the first dose

Title

Adverse events (AEs)

Description

Adverse events (AEs), including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

Time Frame

Up to 4.5 years

Title

Overall Response Rate (ORR)

Description

Assessed according to International Myeloma Working Group (IMWG) response criteria.

Time Frame

up to 4.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-1. 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.

12. IPD Sharing Statement

Learn more about this trial

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

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