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

Keymed Biosciences Co.Ltd120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Multiple Myeloma

Interventions

CM313 injectionBIOLOGICAL

CM313, subcutaneous injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Adverse event

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

Time frame: up to 18 months

Data from ClinicalTrials.gov

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