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

Sponsor
Keymed Biosciences Co.Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06126237
Collaborator
(none)
120
Enrollment
2
Arms
24
Anticipated Duration (Months)

Study Details

Study Description

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
  • Biological: CM313 injection
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Feb 28, 2024
Anticipated Primary Completion Date :
Feb 28, 2026
Anticipated Study Completion Date :
Feb 28, 2026

Arms and Interventions

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

Primary Outcome Measures

  1. Adverse event [up to 18 months]

    Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Keymed Biosciences Co.Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Keymed Biosciences Co.Ltd
ClinicalTrials.gov Identifier:
NCT06126237
Other Study ID Numbers:
  • CM313-040101
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell

Study Results

No Results Posted as of Nov 13, 2023