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

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)

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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