drugset / Trial / NCT06867991

Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis

NCT06867991

Phase 3 Recruiting 200 enrolled The First People's Hospital of Changzhou
RandomizedParallel-groupSingle-blindTreatment

Summary

Autoimmune encephalitis is an autoimmune disease of the central nervous system that targets neuronal autoantigens. Anti-neuronal autoantibodies are produced in patients, with anti-NMDAR antibody being the most common.Anti-NMDAR encephalitis can be severe and life-threatening. Anti-NMDAR autoantibodies against neurons are pathogenic and are mainly produced by autoreactive B cells and plasma cells. Therefore, early elimination of these abnormal immune cells is crucial for rapid improvement of the patient's condition. This study aims to explore the efficacy and safety of B cell depletion therapy (ofatumumab) followed by plasma cell depletion therapy (daratumumab) in the treatment of severe anti-NMDAR autoimmune encephalitis.

Timeline

Start
2024-11-08
Primary completion
2026-11-08
Completion
2027-11-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumumab Monoclonal antibody 4 mg/kg
Comparator Immune Globulin Intravenous (Human) Protein / enzyme biologic Intravenous
Subject Ofatumumab Monoclonal antibody Subcutaneous