to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Moderate to Severe Autoimmune Bullous Disease
This study will set up two cohorts, Cohort 1: Patients with pemphigus, and plan to enroll approximately 20 adults with pemphigus; and Cohort 2: patients with bullous pemphigoid, and plan to enroll approximately 10 adults with bullous pemphigoid. Cohort 1 is divided into Part 1 and Part 2: Part 1 is planned to enroll approximately 10 subjects with pemphigus who had an inadequate response to prior corticosteroid therapy or whose disease uncontrolled despite high-dose corticosteroids. Part 2 is planned to enroll approximately 10 subjects with pemphigus who had an inadequate response to anti-CD20 monoclonal antibody therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
subcutaneous CM336 administration
Dermatology Hospital Affiliated to Shandong First Medical University
Jinan, China
RECRUITINGTo evaluate the efficacy after CM336 treatment
Proportion of subjects in sustained complete remission
Time frame: Up to 52 weeks
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