A Single-center Study of CM313 in Patients With Pemphigus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CM313 injection, glucocorticoids.
- Who it may be relevant to
- Registry conditions: Pemphigus. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Biological 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 - Biological glucocorticoids
Administer medium- or long-acting glucocorticoids 1-3 hours before injection
Primary outcome measures
- Efficacy evaluation [Time frame: up to 52 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sichuan Provincial People's Hospital — Chengdu
Identifiers
NCT: NCT06904040 · CM313-IIS-PP01