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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06900010
- Acronym / sponsor ID
- CM336-IIS-PP01
- Conditions
- Autoimmune Bullous Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shandong First Medical UniversityUniversity, hospital or other
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention(CM336) | Experimental | Biological: CM336 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM336 Injectionsubcutaneous CM336 administration | Biological | Intervention(CM336) |
Primary outcome
To evaluate the efficacy after CM336 treatment
Time frame: Up to 52 weeks
Proportion of subjects in sustained complete remission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
Related trials for Autoimmune Bullous Disease
RecruitingPhase 1
Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Enrolling by invitationPhase 1
Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Active, not recruitingObservational study
Association Between Disease Severity and Clinical, Histopathological, and Eosinophilic Markers in Patients With Bullous Pemphigoid (BP-EPIC)
Bullous Pemphigoid (BP)
RecruitingObservational study
Identification of Cutaneous and Blood Biomarkers Predictive of Response to Systemic Treatments During Chronic Inflammatory Skin Diseases
Atopic Dermatitis, Psoriasis
RecruitingObservational study
Coagulopathy of Immunodermatologic Diseases
Autoimmune Bullous Dermatosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Furen Zhang principal investigator
Dermatology Hospital of Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CM336 Injection in people with Autoimmune Bullous Disease, run by Shandong First Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Furen Zhang (15854179852, splcsy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy after CM336 treatment (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.