A Study to Evaluate CM336 in Adults with Autoimmune Bullous Disease

Phase 1

Recruiting

• Conditions: Autoimmune Bullous Disease
• Interventions: Biological: CM336 Injection

• Registration Number: NCT06900010
• Lead Sponsor: Shandong First Medical University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-23
• Study First Submitted QC: 2025-03-23
• Last Update Submitted: 2025-03-23
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-03-28
• Study Start: 2025-04-01
• Primary Completion: 2026-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention(CM336)	CM336 Injection	-

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy after CM336 treatment	Up to 52 weeks	Proportion of subjects in remission

Trial Locations

Locations (1)

Dermatology Hospital Affiliated to Shandong First Medical University; 🇨🇳 Jinan, China