Clinical Trial

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

Study acronym: RADIA
Recruiting Phase 3
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-03-05; most recent amendment 2026-06-05.
Status change: Active, Not Recruiting → Recruiting 2025-03-17
Trial Details
NCT Number NCT06867991
Lead Sponsor The First People's Hospital of Changzhou
Conditions Anti-N-Methyl-D-Aspartate Receptor Encephalitis
Enrollment 200 participants
Start Date 2024-11-08
Primary Completion 2026-11-08 (estimated)
Study Completion 2027-11-08 (estimated)
Updated on ClinicalTrials.gov 2026-06-09