A Single-center Study of CM313 in Patients With Pemphigus

Not Applicable

Not yet recruiting

• Conditions: Pemphigus
• Interventions: Biological: CM313 injection; Biological: glucocorticoids

• Registration Number: NCT06904040
• Lead Sponsor: Sichuan Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Study Start: 2025-04-01
• Study First Posted: 2025-04-01
• Last Update Posted: 2025-04-01
• Primary Completion: 2027-10-31
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1	CM313 injection	-
Group 1	glucocorticoids	-

Primary Outcome Measures

Name	Time	Method
Efficacy evaluation	up to 52 weeks	The time to achieve disease control and consolidate the end

Trial Locations

Locations (1)

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, China