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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Aged 12 years and above

• Meet the diagnosis of autoimmune encephalitis and the target antigen is a neuronal surface antigen

• Have received at least 3 days of 500-1000mg high-dose methylprednisolone impulse treatment and IVIG (0.4g/kg/d for 5 consecutive days) or at least 5 plasma exchange/immunoadsorption or at least 2 times of efgartigimod treatment

• mRS ≥ 3 points and neuropsychiatric manifestations inadequate to symptomatic treatment

• Informed consent or guardian signed informed consent

Locations
Other Locations
China
The First People's Hospital of Changzhou
RECRUITING
Changzhou
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Wei Xie
13706121930@163.com
+86051968872122
Time Frame
Start Date: 2024-11-08
Estimated Completion Date: 2027-11-08
Participants
Target number of participants: 200
Treatments
Experimental: B cell depleting agent(ofatumumab)combined with daratumumab treatment group
The group receiving B cell depletion plus daratumumab will receive daratumumab intravenously (on the second day of ofatumumab) in addition to ofatumumab, with a dose of 8 mg/kg at weeks 0, 1, 2, and 4, and a dose of 4 mg/kg at weeks 8, 12, 16, 20, and 24. The study will investigate the effect of up to 24 cycles of daratumumab
Active_comparator: Ofatumumab treatment group
Ofatumumab group received subcutaneous injection of ofatumumab at weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24
Active_comparator: Repeated intravenous immunoglobulin/plasma exchange therapy group
At least two cycles of intravenous immunoglobulin/plasma exchange therapy
Sponsors
Leads: The First People's Hospital of Changzhou

This content was sourced from clinicaltrials.gov