A Study to Evaluate CM336 in Adults With Autoimmune Bullous Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CM336 Injection.
- Who it may be relevant to
- Registry conditions: Autoimmune Bullous Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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 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.
Interventions
- Biological CM336 Injection
subcutaneous CM336 administration
Primary outcome measures
- To evaluate the efficacy after CM336 treatment [Time frame: Up to 52 weeks]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Dermatology Hospital Affiliated to Shandong First Medical University — Jinan
Identifiers
NCT: NCT06900010 · CM336-IIS-PP01