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NCT Number: NCT06791824

Study of CM313(SC) Injection in Subjects With Relapsed/Refractory Aplastic Anemia

This is a randomized, open-label, phase IB/II clinical study to evaluate the safety, tolerability and preliminary efficacy of CM313(SC) injection in patients with relapsed/refractory aplastic anemia

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Key information

Conditions

Aplastic Anemia Anemia Anemia, Aplastic Bone Marrow Diseases Bone Marrow Failure Disorders Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Location contact

Jun Shi

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of idiopathic aplastic anemia.
  • Patients must meet the requirements of relapsed/refractory aplastic anemia defined in the protocol.
  • Male or female, age≥18 years.
  • The Eastern Cooperative Oncology Group (ECOG) physical status score ≤2.
  • Willing and able to comply with the requirements for this study and written informed consent.

Exclusion criteria

  • The inherited bone marrow failure syndromes.
  • Previously treated with the anti-CD38 monoclonal antibody.
  • Have an allergy to humanized monoclonal antibody or any part of CM313.
  • Pregnant or breastfeeding females, or females planning to become pregnant during the study.
  • Any condition considered to be ineligible for the study by the investigator.

Treatment and study plan

CM313(SC) injection

Biological

Phase IB: CM313(SC) administered at low dose according to the protocol. Phase II: CM313(SC) administered at different doses based on Phase IB's results.

Primary outcomes

  1. Adverse events (AE)

    Time frame: Up to 52 weeks

    Assess the safety and tolerability

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Jia

CONTACT

[email protected]

028-88610620

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

A Phase IB/II Clinical Study to Assess the Safety, Tolerability and Preliminary Efficacy of CM313(SC) Injection in Subjects With Relapsed/Refractory Aplastic Anemia

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 24, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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