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

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

Study Overview

• Status: Recruiting
• Conditions: Autoimmune Bullous Disease
• Intervention / Treatment: Biological: CM336 Injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Furen Zhang; Phone Number: 15854179852; Email: splcsy@126.com

Study Locations

• China
  • Jinan, China
    • Recruiting
    • Dermatology Hospital Affiliated to Shandong First Medical University
    • Contact: Furen Zhang; Phone Number: 15854179852

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention(CM336)	Biological: CM336 Injection; subcutaneous CM336 administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy after CM336 treatment	Proportion of subjects in sustained complete remission	Up to 52 weeks

Collaborators and Investigators

• Sponsor: Shandong First Medical University
• Investigators: Principal Investigator: Furen Zhang, Dermatology Hospital Affiliated to Shandong First Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: March 23, 2025
• First Submitted That Met QC Criteria: March 23, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CM336-IIS-PP01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No