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

Keymed Biosciences Co.Ltd0 sites120 target enrollmentFebruary 28, 2024

ConditionsMultiple Myeloma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Multiple Myeloma
Sponsor: Keymed Biosciences Co.Ltd
Enrollment: 120
Primary Endpoint: Adverse event
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 28, 2024

End Date

February 28, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Keymed Biosciences Co.Ltd

Responsible Party

Sponsor

Eligibility 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.