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NCT06126237 Clinical Trial

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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06126237
Other study ID # CM313-040101
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date February 28, 2024
Est. completion date February 28, 2026

Study information
Verified date October 2023
Source Keymed Biosciences Co.Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date February 28, 2026
Est. primary completion date February 28, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• CM313 injection
CM313, subcutaneous injection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Keymed Biosciences Co.Ltd

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse event Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) up to 18 months
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