NCT06900010

A Study to Evaluate CM336 in Adults With Autoimmune Bullous Disease

An Open-label, PhaseⅡ Study to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults With Moderate to Severe Autoimmune Bullous Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shandong First Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Autoimmune Bullous Disease

Interventions

Type	Name	Description
BIOLOGICAL	CM336 Injection	subcutaneous CM336 administration

Timeline

• Start date: 2025-04-22
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2025-03-28
• Last updated: 2026-04-06

Locations

1 site across 1 country: China