Autoimmune Bullous DiseasePhase 2NCT06900010
A Study to Evaluate CM336 in Adults With Autoimmune Bullous Disease
A Phase 2 study testing CM336 Injection in people with Autoimmune Bullous Disease, run by Shandong First Medical University at 1 site in China.
Trial summary
to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Moderate to Severe Autoimmune Bullous Disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Bullous Disease
- What is being tested?
- CM336 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2025to 1 Jan 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Dermatology Hospital of Shandong First Medical University
Jinan
Furen Zhang, 15854179852
About this study
Official 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
to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Moderate to Severe Autoimmune Bullous Disease
Read the detailed description
This study will set up two cohorts, Cohort 1: Patients with pemphigus, and plan to enroll approximately 60 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 50 subjects with pemphigus who had an inadequate response to anti-CD20 monoclonal antibody therapy.
- Conditions
- Autoimmune Bullous Disease
- Being tested
- CM336 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM336 InjectionBiological
subcutaneous CM336 administration
| Study group | Role | What they receive |
|---|---|---|
| Intervention(CM336) | Experimental | Not described Receives: Biological: CM336 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy after CM336 treatment
Proportion of subjects in sustained complete remission
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start22 Apr 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Bullous DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong First Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Furen Zhang, Principal investigator, Dermatology Hospital of Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900010
- Sponsor's protocol ID
- CM336-IIS-PP01
- Status last verified
- Oct 2026
- First submitted
- 23 Mar 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No