A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia
NCT ID: NCT07175493
Last Updated: 2025-12-17
Study Results
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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RECRUITING
PHASE1/PHASE2
158 participants
INTERVENTIONAL
2025-11-18
2028-11-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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CM336 injection
CM336 Injection
subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol
Interventions
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CM336 Injection
subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years, male or female.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
* Confirmed diagnosis of immune thrombocytopenia (ITP), warm autoimmune hemolytic anemia (wAIHA), cold agglutinin disease (CAD), mixed autoimmune hemolytic anemia (mAIHA) or Evans Syndrome.
* Relapsed or refractory autoimmune hemolytic anemia.
Exclusion Criteria
* Other types of AIHA or other types of cytopenia
* History of critical diseases that, in the opinion of the investigator, may pose a risk to the safety of subjects or whose exacerbation during the study could compromise the efficacy or safety analysis of the results.
* Received any treatment of anti-B Cell Maturation Antigen(BCMA) antibody.
* Evaluated unsuitable to participant in this study by investigator.
18 Years
ALL
No
Sponsors
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Keymed Biosciences Co.Ltd
INDUSTRY
Responsible Party
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Locations
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Henan Cancer Hospital
Zhengzhou, Henan, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China
Blood Disease Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xuliang Shen Heping Hospital Affiliated to Changzhi Medical College
Role: primary
Other Identifiers
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CM336-125101
Identifier Type: -
Identifier Source: org_study_id