A Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma
Phase 1
Not yet recruiting
- Conditions
- Multiple Myeloma
- Interventions
- Biological: CM313 injection
- Registration Number
- NCT06126237
- Lead Sponsor
- Keymed Biosciences Co.Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 120
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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description CM313 CM313 injection CM313 injection, subcutaneous CM313 + concomitant medication CM313 injection CM313 injection, subcutaneous
- Primary Outcome Measures
Name Time Method Adverse event up to 18 months Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
- Secondary Outcome Measures
Name Time Method