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

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.

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.