RecruitingPhase 2NCT06900010
A Study to Evaluate CM336 in Adults With Autoimmune Bullous Disease
An Open-label, PhaseⅡ Study to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults With Moderate to Severe Autoimmune Bullous Disease
Sponsor
Shandong First Medical University
Enrollment
30 participants
Start Date
Apr 22, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Moderate to Severe Autoimmune Bullous Disease
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- \. Confirmed diagnosis of autoimmune bullous disease；
- \. Age ≥18 years, regardless of gender；
- \. Voluntarily signed informed consent form, with understanding of the study's nature, purpose, procedures, and willingness to comply with trial requirements.
Exclusion Criteria4
- \. History of clinically significant diseases that, in the investigator's judgment, may pose safety risks to the subject during participation；
- \. Prior treatment with anti-B-cell maturation antigen (BCMA) therapy；
- \. History of allergic reactions to humanized monoclonal antibodies or known allergy to any component of CM336；
- \. Any other condition deemed by the investigator to render the subject unsuitable for study participation.
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Interventions
BIOLOGICALCM336 Injection
subcutaneous CM336 administration
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06900010