A Single-center Study of CM313 in Patients With Pemphigus

Sichuan Provincial People's Hospital

Status

Not yet enrolling

Conditions

Pemphigus

Treatments

Biological: CM313 injection

Biological: glucocorticoids

Study type

Interventional

Funder types

Other

Identifiers

NCT06904040

CM313-IIS-PP01

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.