CM313 injection: 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
glucocorticoids: Administer medium- or long-acting glucocorticoids 1-3 hours before injection
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Efficacy evaluation — up to 52 weeks The time to achieve disease control and consolidate the end
Trial sites (1)
Facility
City
Region
Status
Sichuan Provincial People's Hospital
Chengdu
China
More Sichuan Provincial People's Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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