NCT06663943

A Randomized Study on Pemphigus Treatment With Humanized CD38 Antibody CM313.

A Prospective, Single-Center, Open-Label, Randomized Clinical Study on the Treatment of Pemphigus With a Novel Humanized CD38 Monoclonal Antibody (CM313)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Chao Ji · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Pemphigus is characterized by the presence of IgG antibodies that lead to the loss of keratinocyte adhesion, resulting in blister formation. The etiology of pemphigus antibodies is multifactorial, involving immune dysregulation, genetic predisposition, and potential viral triggers. CD38, a multifunctional transmembrane glycoprotein, plays a crucial role in B-cell maturation and function. CM313, a novel humanized monoclonal antibody targeting CD38, has shown promise in clinical trials for autoimmune diseases, including refractory/relapsed multiple myeloma (RRMM), systemic lupus erythematosus (SLE), and immune thrombocytopenia (ITP). By binding to CD38 on B cells, CM313 modulates B-cell activation, proliferation, and differentiation, potentially reducing the production of autoantibodies, such as those against desmogleins 1/3 in pemphigus. Preclinical studies have demonstrated that CM313 effectively inhibits CD38 enzymatic activity through antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), antibody-dependent cellular phagocytosis (ADCP), and Fc-mediated apoptosis. The long-term modulation of B-cell-mediated immune responses by CM313, through the depletion of both short-lived and long-lived plasma cells, suggests a novel therapeutic strategy for pemphigus by targeting the production of pathogenic autoantibodies.

Conditions

• Pemphigus Disease
• Pemphigus Vulgaris (PV)

Interventions

Type	Name	Description
DRUG	CM313 (SC)	CM313 is an anti-CD38 monoclonal antibody that can help pemphigus patients systematically treat rapid glucocorticoid reduction. It has been proven to have good safety in non-clinical studies and is suitable for human studies
DRUG	Glucocorticoids	Patients in the control group receive azathioprine in combination with steroid therapy.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-10-30
• Completion: 2026-11-01
• First posted: 2024-10-29
• Last updated: 2024-10-29