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

A Phase I/II, Multiple Center, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06126237

Enrollment

120

Registered

2023-11-13

Start date

2024-02-28

Completion date

2026-02-28

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

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.

Interventions

BIOLOGICALCM313 injection

CM313, subcutaneous injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Adverse event	up to 18 months	Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026