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A Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06126237
Recruitment Status : Not yet recruiting
First Posted : November 13, 2023
Last Update Posted : November 13, 2023
Sponsor:
Information provided by (Responsible Party):
Keymed Biosciences Co.Ltd

Study Description
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Brief Summary:
This is a multi-center, open-label, Phase 1/2 study to evaluate the safety, tolerability, Pharmacokinetics, pharmacodynamics and Preliminary Efficacy of CM313 in Subjects with Relapsed or Refractory Multiple Myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: CM313 injection Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Multiple Center, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma
Estimated Study Start Date : February 28, 2024
Estimated Primary Completion Date : February 28, 2026
Estimated Study Completion Date : February 28, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: CM313
CM313 injection, subcutaneous
 Biological: CM313 injection
CM313, subcutaneous injection
Experimental: CM313 + concomitant medication
CM313 injection, subcutaneous
 Biological: CM313 injection
CM313, subcutaneous injection


Outcome Measures
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Primary Outcome Measures :
  1. Adverse event [ Time Frame: up to 18 months ]
    Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects age ≥ 18 years.
  • Subjects diagnosed with multiple myeloma.
  • Subjects with measurable lesions.
  • Women of childbearing potential with negative pregnancy testing.
  • Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.

Exclusion Criteria:

  • Previous treatment with any anti-CD38 therapy.
  • Vaccinated with live, attenuated vaccine within 4 weeks prior to the first dose.
  • Positive for human immunodeficiency virus (HIV) antibodies.
  • Syphilis antibody positive.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Keymed Biosciences Co.Ltd
ClinicalTrials.gov Identifier: NCT06126237    
Other Study ID Numbers: CM313-040101
First Posted: November 13, 2023    Key Record Dates
Last Update Posted: November 13, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases