A Single-center Study of CM313 in Patients With Pemphigus
NCT06904040 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-04-01
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.
Conditions
- 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
-
Administer medium- or long-acting glucocorticoids 1-3 hours before injection
Sponsors & Collaborators
-
Sichuan Provincial People's Hospital
lead OTHER
Principal Investigators
-
Jianing Yang · Sichuan Provincial People's Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-01
- Primary Completion
- 2027-10-31
- Completion
- 2028-04-01
Countries
- China
Study Locations
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