NCT06904040

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sichuan Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-10-31
• Completion: 2028-04-01
• First posted: 2025-04-01
• Last updated: 2025-04-01

Locations

1 site across 1 country: China