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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention(CM336) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM336 Injection | Biological | subcutaneous CM336 administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy after CM336 treatment | Proportion of subjects in sustained complete remission | Up to 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Furen Zhang | Contact | 15854179852 | splcsy@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Furen Zhang | Dermatology Hospital affiliated to Shandong First Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Hospital Affiliated to Shandong First Medical University | Recruiting | Jinan | China |
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