A Study to Evaluate CM336 in Adults with Autoimmune Bullous Disease

Shandong First Medical University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Autoimmune Bullous Disease

Treatments: Biological: CM336 Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06900010

CM336-IIS-PP01

Details and patient eligibility

About

to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Moderate to Severe Autoimmune Bullous Disease

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Intervention(CM336)

Experimental group

Treatment:

Biological: CM336 Injection