[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anti-n-methyl-d-aspartate-receptor-encephalitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anti-n-methyl-d-aspartate-receptor-encephalitis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100582798","phase-3-safety-and-efficacy-of-combined-b-cell-depleting-therapy-and-daratumumab-in-autoimmune-encephalitis-100582798",false,"NCT06867991","Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis","RADIA","Inclusion Criteria:\n\n1. Aged 12 years and above\n2. Meet the diagnosis of autoimmune encephalitis and the target antigen is a neuronal surface antigen\n3. Have received at least 3 days of 500-1000mg high-dose methylprednisolone impulse treatment and IVIG (0.4g\u002Fkg\u002Fd for 5 consecutive days) or at least 5 plasma exchange\u002Fimmunoadsorption or at least 2 times of efgartigimod treatment\n4. mRS ≥ 3 points and neuropsychiatric manifestations inadequate to symptomatic treatment\n5. Informed consent or guardian signed informed consent\n\nExclusion Criteria:\n\n1. Severe active or chronic infection in the opinion of the investigator.\n2. Concurrently\u002Fpreviously 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.\n3. 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.\n4. Known history of allergy or reaction to any component of the investigational drug formulation, or history of allergic reaction after any biological treatment.\n5. Any of the following at screening (one repeat test may be performed during the same screening period to confirm results prior to randomization):\n\n   Aspartate aminotransferase (AST) \\> 2.5 × upper limit of normal (ULN)\n\n   Alanine aminotransferase (ALT) \\> 2.5 × upper limit of normal (ULN)\n\n   Total bilirubin \\> 1.5 × ULN (unless due to Gilbert's syndrome)\n\n   Platelet count \\\u003C 75,000\u002FμL (or \\\u003C 75 × 109\u002FL)\n\n   Hemoglobin \\\u003C 8 g\u002FdL (or \\\u003C 80 g\u002FL)\n\n   Total white blood cell count \\\u003C 2,500 cells\u002Fmm3\n\n   Total immunoglobulins \\\u003C 600 mg\u002FdL\n\n   Absolute neutrophil count \\\u003C 1200 cells\u002FμL\n\n   CD4 T lymphocyte count \\\u003C 300 cells\u002FµL\n\n   Receipt of any experimental B cell depleting agent, unless CD19 B Cell levels have returned to above the lower limit of normal before randomization A history of severe drug allergies or anaphylaxis to two or more foods or drugs (including known sensitivity to acetaminophen\u002Fparacetamol, diphenhydramine or equivalent antihistamines, and methylprednisolone or equivalent glucocorticoids).\n\n   A known history of primary immunodeficiency (congenital or acquired) or underlying conditions, such as human immunodeficiency virus (HIV) infection or splenectomy, that predispose the participant to infection.\n\n   Any of the following received within 3 months before randomization Natalizumab (Tysabri®) Cyclosporin Methotrexate Mitoxantrone Cyclophosphamide Azathioprine\n6. Confirmed positive hepatitis B serology (hepatitis B surface antigen and core antigen) and\u002For positive hepatitis C PCR at screening.\n7. 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.\n8. Received any live or attenuated vaccine (inactivated vaccine is acceptable) within 3 weeks before enrollment.\n9. Received BCG vaccine within 1 year before enrollment.","ALL","12 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","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.",[26],"Anti-N-Methyl-D-Aspartate Receptor Encephalitis",[26,28,29,30],"Ofatumumab","Daratumumab","severe autoimmune encephalitis","RECRUITING","2026-06-05",{"date":34,"type":35},"2026-06-09","ACTUAL",{"date":37,"type":35},"2024-11-08",{"date":39,"type":20},"2027-11-08",{"name":41,"class":42},"The First People's Hospital of Changzhou","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100555299","phase-2-efficacy-and-safety-of-taitacept-in-treatment-of-refractory-or-recurrent-anti-nmdaranti-lgi1-encephalitis-100555299","NCT06510283","Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR\u002Fanti-LGI1 Encephalitis","Inclusion Criteria:\n\n1. Age ≥14 years old, male or female;\n2. Symptoms of autoimmune encephalitis (AE) ≤ 9 months prior to enrollment;\n3. Diagnosed as autoimmune encephalitis, diagnostic criteria as follows:\n\n   1. Rapid onset (\\\u003C3 months) of at least four of the following six major symptoms:\n\n      * Abnormal (mental) behavior or cognitive dysfunction\n      * Speech dysfunction (verbal urgency, hypospeech, mutism)\n      * Seizures\n      * Movement disorders, dyskinesias, or postural rigidity\u002Fabnormalities\n      * Decreased level of consciousness\n      * Autonomic dysfunction or central hypoventilation in the presence of one or more of the six major symptoms;\n   2. Positive anti-NMDAR (GluN1) IgG antibody detected in CSF or positive serum and\u002For cerebrospinal fluid LGI1 antibody; c．Reasonable exclusion of other etiologies and other well-defined encephalitis syndromes (e.g., Bickerstaff brainstem encephalitis, acute disseminated encephalomyelitis, Hashimoto encephalopathy, primary CNS vasculitis, Rasmussen encephalitis);\n4. Refractory AE: ineffective treatment with steroids and rituximab or other immunosuppressants, post-treatment mRS score≥2 (stable for at least 24 hours）;Recurrent AE: at least 2 months after 1st or 2nd line treatment, new symptoms or worsening of existing symptoms (mRS increase\\>1); 5）Doses of steroids and other immunosuppressants (e.g. azathioprine, mycophenolate mofetil, cyclophosphamide) should be stabilised for 4 weeks prior to enrolment; 6）Ability to obtain patient or proxy consent; 7）Women of childbearing potential should use effective contraception during treatment or avoid heterosexual intercourse for at least 3 months after the last dose of talitacicept;\n\nExclusion Criteria:\n\n1. History of other autoimmunity such as SLE, RA, SS. Patients with hyperthyroidism and hypothyroidism cannot be excluded;\n2. Abnormal laboratory indicators, including but not limited to the following indicators:\n\n   White blood cell count\\\u003C3×10\\^9 \u002FL Neutrophil count\\\u003C1.5×10\\^9 \u002FL Hemoglobin\\\u003C85g\u002FL Blood platelet count\\\u003C80×10\\^9 \u002FL Serum creatinine\\>1.5×ULN TBil(total bilirubin) \\>1.5×ULN ALT\\>3× ULN AST\\>3× ULN Alkaline phosphatase\\>2× ULN Creatine kinase\\>5× ULN\n3. Evidence of active infection such as shingles, HIV or active tuberculosis, etc.\n4. Currently have active hepatitis or have severe liver disease and a history of it.\n\n   * Patiens with abnormal Hepatitis B test as follows should be excluded: HbsAg positive; HbsAg negative but HbcAb positive, and HBV-DNA positive. Whereas patients with HbsAg negative but HbcAb positive, and HBV-DNA negative can be included.\n   * Exclude patients who are positive for hepatitis C antibodies ;\n5. Uncontrolled diabetes mellitus: Glycosylated hemoglobin\\>9.0% or fasting blood glucose≥11.1mmol\u002FL;\n6. Received any live vaccine within 3 months prior to enrollment or planned to receive any vaccine during the study;\n7. Received rituximab or other biological therapies within 1 month prior to enrollment;\n8. Malignancy;\n9. Allergic to human biological products;\n10. Participated in any clinical trial within 28 days prior to enrollment or within 5 times the half-life of the investigational drug participating in the clinical trial\n11. Patients who plan to have children during the trial, or who are pregnant or breastfeeding;\n12. Alcohol or drug abuse\u002Faddiction is known to have an impact on compliance with trial requirements;\n13. Patients who are deemed unsuitable for the trial by the investigator (e.g., those with severe mental disorders).","14 Years",{"count":51,"type":20},10,[53],"PHASE2","The main objective is to explore the efficacy and safety of Telitacicept in the treatment of refractory\u002Frecurrent anti-NMDAR and anti-LGI1 encephalitis.\n\nThrough this prospective, single-center, open-label clinical trial, we aim to investigate the effectiveness and safety of Telitacicept in refractory\u002Frecurrent anti-NMDAR and anti-LGI1 encephalitis by add-on therapy of Telitacicept combined with traditional treatment.",[26],"2024-11-18",{"date":58,"type":35},"2024-11-20",{"date":60,"type":20},"2024-12-01",{"date":62,"type":20},"2028-07-01",{"name":64,"class":42},"Beijing Tongren Hospital",1]