A Study to Evaluate CM336 in Adults With Autoimmune Bullous Disease
ConditionAutoimmune Bullous Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShandong First Medical University
About this trial
to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Moderate to Severe Autoimmune Bullous Disease
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Confirmed diagnosis of autoimmune bullous disease；
2. Age ≥18 years, regardless of gender；
3. Voluntarily signed informed consent form, with understanding of the study's nature, purpose, procedures, and willingness to comply with trial requirements.
Disqualifiers
1. History of clinically significant diseases that, in the investigator's judgment, may pose safety risks to the subject during participation；
2. Prior treatment with anti-B-cell maturation antigen (BCMA) therapy；
3. History of allergic reactions to humanized monoclonal antibodies or known allergy to any component of CM336；
4. Any other condition deemed by the investigator to render the subject unsuitable for study participation.
Trial design
Design model
Single group
Treatments tested in this trial
CM336 Injection
Biological/Vaccinesubcutaneous CM336 administration
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Intervention(CM336)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the efficacy after CM336 treatment
Proportion of subjects in sustained complete remission
Time frame
Up to 52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov