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NCT Number: NCT06900010

A Study to Evaluate CM336 in Adults With Autoimmune Bullous Disease

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermatology Hospital Affiliated to Shandong First Medical University

Jinan, China

Location status: Recruiting

Location contact

Furen Zhang

CONTACT

15854179852

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CM336 Injection

Biological

subcutaneous CM336 administration

Primary outcomes

  1. To evaluate the efficacy after CM336 treatment

    Time frame: Up to 52 weeks

    Proportion of subjects in sustained complete remission

Study contacts

Contact information is provided by the study sponsor or research team.

Furen Zhang

CONTACT

[email protected]

15854179852

Sponsors and collaborators

Lead sponsor

Shandong First Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 28, 2025
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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