Evaluating CM336 for treating autoimmune bullous disease in adults
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
This study is testing a new treatment called CM336 to see if it can help adults with moderate to severe autoimmune bullous disease feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shandong First Medical University Academic / other |
| Locations | 1 site (Jinan) |
| Trial ID | NCT06900010 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of CM336, a bispecific antibody targeting BCMA/CD3, in adults diagnosed with moderate to severe autoimmune bullous disease. Participants will receive injections of CM336 and will be monitored for their response to the treatment. The study includes both Phase 1 and Phase 2 evaluations to determine the optimal dosage and effectiveness of the intervention. Eligible participants must be at least 18 years old and provide informed consent to join the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of autoimmune bullous disease.
Not a fit: Patients with a history of significant diseases that may pose safety risks or those who have previously received BCMA therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from autoimmune bullous disease.
How similar studies have performed: While this approach is novel in the context of autoimmune bullous disease, similar bispecific antibody therapies have shown promise in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Jinan
- Dermatology Hospital Affiliated to Shandong First Medical University — Jinan, China (Recruiting)
Study contacts
- Principal investigator: Furen Zhang — Dermatology Hospital affiliated to Shandong First Medical University
- Study coordinator: Furen Zhang
- Email: splcsy@126.com
- Phone: 15854179852
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.