Actively Recruiting
Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis
Led by The First People's Hospital of Changzhou · Updated on 2025-07-15
200
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 12 years and above
- Diagnosis of autoimmune encephalitis with a neuronal surface antigen target
- Received at least 3 days of 500-1000 mg high-dose methylprednisolone and intravenous immunoglobulin (0.4 g/kg/day for 5 days), or at least 5 plasma exchange/immunoadsorption treatments, or at least 2 treatments of efgartigimod
- Modified Rankin Scale score of 3 or higher with neuropsychiatric symptoms not adequately managed by symptomatic treatment
- Signed informed consent by participant or guardian
You will not qualify if you...
- Severe active or chronic infection as judged by the investigator
- Participation in another investigational therapy trial within 4 weeks or five half-lives of that therapy before randomization
- Women who are pregnant, lactating, or planning pregnancy within six months from enrollment to last study drug dose
- Known allergy or reaction to any components of the investigational drugs or prior biological treatments
- Abnormal liver function tests or blood counts exceeding specified limits at screening
- Receipt of experimental B cell depleting agents without CD19 B cell recovery prior to randomization
- History of severe allergies or anaphylaxis to two or more foods or drugs including acetaminophen, diphenhydramine, or glucocorticoids
- Known primary immunodeficiency or conditions increasing infection risk such as HIV or splenectomy
- Use of certain immunosuppressive drugs within 3 months before randomization
- Positive hepatitis B or C tests at screening
- History of cancer except treated ovarian/extraovarian teratoma or germ cell tumors and certain skin cancers treated successfully more than 3 months prior
- Receipt of live or attenuated vaccines within 3 weeks before enrollment
- Receipt of BCG vaccine within 1 year before enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Actively Recruiting
2
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China, 213000
Actively Recruiting
Research Team
W
Wei Xie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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