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

K

Keymed Biosciences

Status and phase

Not yet enrolling
Phase 2
Phase 1

Conditions

Multiple Myeloma

Treatments

Biological: CM313 injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT06126237
CM313-040101

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

120 participants in 2 patient groups

CM313
Experimental group
Description:
CM313 injection, subcutaneous
Treatment:
Biological: CM313 injection
CM313 + concomitant medication
Experimental group
Description:
CM313 injection, subcutaneous
Treatment:
Biological: CM313 injection

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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