Status:
NOT_YET_RECRUITING
A Single-center Study of CM313 in Patients With Pemphigus
Lead Sponsor:
Sichuan Provincial People's Hospital
Conditions:
Pemphigus
Eligibility:
All Genders
18-80 years
Phase:
NA
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 pemp...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06904040
Start Date
April 1 2025
End Date
April 1 2028
Last Update
April 1 2025
Active Locations (1)
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1
Sichuan Provincial People's Hospital
Chengdu, China