A Randomized Study on Pemphigus Treatment With Humanized CD38 Antibody CM313. (NCT06663943) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Randomized Study on Pemphigus Treatment With Humanized CD38 Antibody CM313.
100 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Patients who meet the diagnostic criteria for pemphigus, including:
✓. Adult patients aged between 18 and 80 years.
✓. Patients with moderate to severe generalized or vegetans pemphigus, as determined by a Pemphigus Disease Area Index (PDAI) score of 9-24 for moderate and ≥25 for severe.
✓. Patients receiving CM313 treatment for the first time, including those with inadequate response to prior rituximab or other treatments.
✓. Patients who have provided informed consent, agree to the treatment plan, and are willing to participate in follow-up assessments.
Exclusion criteria
✕. Patients diagnosed with proliferative pemphigus, paraneoplastic pemphigus, or other autoimmune bullous diseases.
✕. Patients who have received intravenous cyclophosphamide, plasmapheresis, or immunoadsorption treatment within 8 weeks prior to randomization.
✕. Patients who have undergone rituximab or other B-cell targeted therapies within 3 months prior to randomization.