A Single-center Study of CM313 in Patients With Pemphigus
A Prospective, Single-Center, Single-Arm Clinical Study to Evaluate the Novel Humanized Cluster of Differentiation 38(CD38) Monoclonal Antibody (CM313) for the Treatment of Pemphigus
1 other identifier
interventional
20
1 country
1
Brief Summary
A prospective, single-center, single-arm clinical study aimed to explore the efficacy and safety of the anti-CD38 monoclonal antibody CM313 combined with low-dose glucocorticoids in patients with pemphigus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2025
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
March 25, 2025
CompletedFirst Posted
Study publicly available on registry
April 1, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
April 1, 2025
March 1, 2025
2.6 years
March 25, 2025
March 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy evaluation
The time to achieve disease control and consolidate the end
up to 52 weeks
Study Arms (1)
Group 1
EXPERIMENTALInterventions
600 mg (4 mL per vial), administer once at Week 0, 1, and 2, and then every 6 months thereafter or determined based on clinical assessment
Administer medium- or long-acting glucocorticoids 1-3 hours before injection
Eligibility Criteria
You may qualify if:
- Clinical manifestations:① Flaccid blisters and bullae on the skin that are prone to rupture.② Persistent erosions formed after the rupture of blisters and bullae.③ Blisters or erosions on the mucous membranes.④ Positive Nikolsky's sign.
- Adult patients aged between 18 and 80 years old.
- Moderate - to - severe pemphigus vulgaris/foliaceus: According to the Pemphigus Disease Area Index (PDAI) score, a score of 9 - 24 indicates moderate severity, and a score of ≥25 indicates severe severity.
You may not qualify if:
- Pregnant or lactating women and women planning to conceive.
- Patients with known positive serology for HIV, syphilis, tuberculosis, hepatitis B, or hepatitis C in the active stage of the disease.
- Patients who have received intravenous cyclophosphamide injection, plasma exchange, or immunoadsorption therapy within 8 weeks before screening and enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sichuan Provincial People's Hospital
Chengdu, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianing Yang
Sichuan Provincial People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Dermatology
Study Record Dates
First Submitted
March 25, 2025
First Posted
April 1, 2025
Study Start
April 1, 2025
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
April 1, 2025
Record last verified: 2025-03