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Trial Title:
A Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma
NCT ID:
NCT06126237
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CM313 injection
Description:
CM313, subcutaneous injection
Arm group label:
CM313
Arm group label:
CM313 + concomitant medication
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
February 28, 2024
Completion date:
February 28, 2026
Lead sponsor:
Agency:
Keymed Biosciences Co.Ltd
Agency class:
Industry
Source:
Keymed Biosciences Co.Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06126237
