NCT06900010

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
8mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Apr 2025Jan 2027

First Submitted

Initial submission to the registry

March 23, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

March 23, 2025

Last Update Submit

March 23, 2025

Conditions

Autoimmune Bullous Disease

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy after CM336 treatment

    Proportion of subjects in remission

    Up to 52 weeks

Study Arms (1)

Intervention(CM336)

EXPERIMENTAL
Biological: CM336 Injection

Interventions

CM336 InjectionBIOLOGICAL

subcutaneous CM336 administration

Intervention(CM336)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Confirmed diagnosis of autoimmune bullous disease；
  • \. Age ≥18 years, regardless of gender；
  • \. Voluntarily signed informed consent form, with understanding of the study's nature, purpose, procedures, and willingness to comply with trial requirements.

You may not qualify if:

  • \. History of clinically significant diseases that, in the investigator's judgment, may pose safety risks to the subject during participation；
  • \. Prior treatment with anti-B-cell maturation antigen (BCMA) therapy；
  • \. History of allergic reactions to humanized monoclonal antibodies or known allergy to any component of CM336；
  • \. Any other condition deemed by the investigator to render the subject unsuitable for study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology Hospital Affiliated to Shandong First Medical University

Jinan, China

RECRUITING

Study Officials

  • Furen Zhang

    Dermatology Hospital affiliated to Shandong First Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Furen Zhang

CONTACT

15854179852splcsy@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2025

First Posted

March 28, 2025

Study Start

April 1, 2025

Primary Completion

January 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations

CN(1)