Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorThe First People's Hospital of Changzhou
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Known history of allergy or reaction to any component of the investigational drug formulation, or history of allergic reaction after any biological treatment.
Trial design
Treatments tested in this trial
- Ofatumumab combined with daratumumab
- Ofatumumab
- Repeated intravenous immunoglobulin/plasma exchange therapy
Treatment groups
200 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov