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

NCT ID: NCT06126237

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-28

Study Completion Date

2026-02-28

Brief Summary

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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

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CM313

CM313 injection, subcutaneous

Group Type EXPERIMENTAL

CM313 injection

Intervention Type BIOLOGICAL

CM313, subcutaneous injection

CM313 + concomitant medication

CM313 injection, subcutaneous

Group Type EXPERIMENTAL

CM313 injection

Intervention Type BIOLOGICAL

CM313, subcutaneous injection

Interventions

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CM313 injection

CM313, subcutaneous injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keymed Biosciences Co.Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CM313-040101

Identifier Type: -

Identifier Source: org_study_id

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