A Study to Evaluate CM336 in Adults with Autoimmune Bullous Disease

NCT ID: NCT06900010

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2027-01-01

Brief Summary

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

Detailed Description

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Conditions

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Autoimmune Bullous Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention(CM336)

Group Type EXPERIMENTAL

CM336 Injection

Intervention Type BIOLOGICAL

subcutaneous CM336 administration

Interventions

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CM336 Injection

subcutaneous CM336 administration

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong First Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Furen Zhang

Role: PRINCIPAL_INVESTIGATOR

Dermatology Hospital affiliated to Shandong First Medical University

Locations

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Dermatology Hospital Affiliated to Shandong First Medical University

Jinan, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Furen Zhang

Role: CONTACT

15854179852

Facility Contacts

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Furen Zhang

Role: primary

15854179852

Other Identifiers

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CM336-IIS-PP01

Identifier Type: -

Identifier Source: org_study_id

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