Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis (NCT06867991) | Clinical Trial Compass
RecruitingPhase 3
Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis
China200 participantsStarted 2024-11-08
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Severe active or chronic infection in the opinion of the investigator.
✕. Concurrently/previously participated in another clinical study involving investigational therapy within 4 weeks or 5 published half-lives of the investigational therapy (whichever is longer) before randomization.
✕. Women who are lactating or pregnant, or intend to become pregnant at any time within six months from study enrollment to the last dose of study drug.
What they're measuring
1
Time to mRS<=2, i.e. the proportion of patients with mRS scores of 0-2
✕. Known history of allergy or reaction to any component of the investigational drug formulation, or history of allergic reaction after any biological treatment.
✕. Any of the following at screening (one repeat test may be performed during the same screening period to confirm results prior to randomization):
✕. Confirmed positive hepatitis B serology (hepatitis B surface antigen and core antigen) and/or positive hepatitis C PCR at screening.
✕. History of cancer, other than ovarian or extraovarian teratoma (also known as dermoid cyst) or germ cell tumor, or cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma. Treatment of squamous cell carcinoma and basal cell carcinoma should have documented successful curative treatment more than 3 months before randomization.
✕. Received any live or attenuated vaccine (inactivated vaccine is acceptable) within 3 weeks before enrollment.