Autoimmune encephalitis
Conditions
Interventions
Ofatumumab + Daratumumab Combination Treatment Group:Ofatumumab + Daratumumab Combination Treatment
Ofatumumab Treatment Group:Ofatumumab Treatment
Repeated IVIG/PE Group:Repeated IVIG/PE
Sponsors
the First People's Hospital of Changzhou
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age: Participants must be aged 12 years or older. 2.Disease Diagnosis: Diagnosis of autoimmune encephalitis with target antigens being neuronal surface antigens. 3.rior Treatment Experience: Participants must have received high-dose methylprednisolone (500-1000 mg) for at least 3 days in conjunction with IVIG (0.4 g/kg/day for 5 consecutive days); Or must have undergone at least 5 sessions of plasma exchange/immune adsorption treatment; Or must have received Eculizumab treatment at least 2 times. 4.mRS Score: Participants must have a modified Rankin Scale (mRS) score of = 4. 5.Informed Consent: Informed consent must be signed by the participant themselves or their guardian, indicating their understanding of the study purpose, process, and potential risks.
Exclusion criteria
Exclusion criteria: 1.The investigator believes there is a serious active or chronic infection. 2.Participation in another clinical study involving investigational treatment within 4 weeks or 5 half-lives of the published investigational treatment (whichever is longer) prior to randomization. 3.Women who are pregnant or breastfeeding, or women who plan to become pregnant at any time within six months after the last dose of investigational drug. 4.History of allergy or reaction to any component of the investigational drug formulation, or history of allergic reactions following any biological therapy. 5.At screening (a repeat test may be performed within the same screening period to confirm results prior to randomization), any of the following: Aspartate aminotransferase (AST) > 2.5× upper limit of normal (ULN) Alanine aminotransferase (ALT) > 2.5× ULN Total bilirubin > 1.5×ULN (unless due to Gilbert's syndrome) Platelet count < 75,000/µL (or < 75×10^9/L) Hemoglobin < 8 g/dL (or < 80 g/L) Total white blood cell count < 2,500 cells/mm³ Total immunoglobulin < 600 mg/dL Absolute neutrophil count < 1,200 cells/µL CD4 T lymphocyte count < 300 cells/µL Received any experimental B cell depleting agent unless CD19 B cell levels have recovered to above the lower limit of normal before randomization History of severe drug allergy or allergic reactions to two or more food or drugs (including known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamines, and methylprednisolone or equivalent glucocorticoids). Known history of primary immunodeficiency disease (congenital or acquired) or underlying conditions, such as HIV infection or splenectomy, that would make participants susceptible to infection. Received any of the following within the 3 months prior to randomization: Natalizumab (Tysabri®) Cyclosporine Methotrexate Mitoxantrone Cyclophosphamide Azathioprine; 6.Positive hepatitis B serology (hepatitis B surface antigen and core antigen) and/or positive hepatitis C PCR confirmed at screening. 7.History of cancer, except for ovarian or teratoma (also known as dermoid cysts) or germ cell tumors, or skin squamous cell carcinoma or basal cell carcinoma. Treatment for squamous cell carcinoma and basal cell carcinoma must have been documented as cured for over 3 months prior to randomization. 8.Administration of any live or attenuated vaccine within 3 weeks prior to enrollment (inactivated vaccines may be administered). 9.Vaccination with Bacillus Calmette-Guérin (BCG) vaccine within the past year prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with an mRS score of 0-2 at 16 weeks after treatment initiation; | — |
Secondary
| Measure | Time frame |
|---|---|
| mRS score at 6 weeks of treatment;CASE score at 6 weeks of treatment;Number of patients requiring rescue therapy at 6 weeks;mRS score at 16 weeks;CASE score at 16 weeks of treatment;ICU treatment time;Cognitive function at 24 weeks;Survival rate at 48 weeks of treatment;Treatment-emergent adverse events (TEAEs); | — |
Countries
China
Contacts
Public ContactXuegan Lian
the First People's Hospital of Changzhou
Outcome results
None listed