[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autoimmune-diseases-of-the-nervous-system\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autoimmune-diseases-of-the-nervous-system":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,61,87,119,146,178],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100564264","phase-1-a-phase-1-study-of-anitocabtagene-autoleucel-for-the-treatment-of-subjects-with-non-oncology-plasma-cell-related-diseases-100564264",false,"NCT06626919","A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases","Inclusion Criteria:\n\n* Subject must be 18 years of age or older\n* Must have MGFA clinical classification Grades 2-4A at time of screening\n* Subject must have clinically active disease and requiring ongoing therapy for GMG\n* MG-ADL score 6 and QMG score \\>10 at screening\n* GMG specific autoantibodies must be above the reference laboratory ULN\n\nExclusion Criteria:\n\n* Subject is pregnant or breastfeeding\n* Treatment with Anti-CD20 agents, calcineurin inhibitors, FcRN inhibitors, azathioprine, mycophenolate mofetil, methotrexate, or cyclophosphamide within the specified time frame prior to leukapheresis or prior to anito-cel infusion\n* Previous treatment with any gene therapy, chimeric antigen receptor therapy or T cell engager\n* Previous thymectomy within 6 months of screening\n* Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator","ALL","18 Years",{"count":18,"type":19},30,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","A Phase 1 dose-escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of anito-cel in subjects with generalized myasthenia gravis (GMG). Anitocabtagene autoleucel (anito-cel) is a BCMA-directed CAR-T cell therapy.",[25,26,27,28,29,30,31],"Muscular Diseases","Neuromuscular Manifestations","Autoimmune","Autoimmune Diseases","Autoimmune Diseases of the Nervous System","Myasthenia Gravis","Muscle Weakness",[33,34,35,36,37,38,39,40,30,41,42,43,44,45,46,47],"ARC-311","CART","CAR-T","BCMA","Anito-cel","Generalized Myasthenia Gravis","gMG","MG","non-oncology plasma cell","autoimmune","auto-antibody","chimeric antigen receptor","D-Domain chimeric antigen receptor","B-cell maturation antigen (BCMA)","anitocabtagene autoleucel","RECRUITING","2026-02-24",{"date":51,"type":52},"2026-02-25","ACTUAL",{"date":54,"type":52},"2025-04-30",{"date":56,"type":19},"2028-04",{"name":58,"class":59},"Arcellx, Inc.","INDUSTRY",13,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":20,"phases":72,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100577340","jy231-injection-for-the-treatment-of-relapsedrefractory-neurologic-immune-disorders-100577340","NCT06797024","JY231 Injection for the Treatment of Relapsed\u002FRefractory Neurologic Immune Disorders","An Early Exploratory Clinical Study of the Safety, Tolerability, and Preliminary Efficacy of JY231 Injection for the Treatment of Relapsed\u002FRefractory Neurologic Immune Disorders","JY231 NID","Inclusion Criteria:\n\n1. Male or female subjects (both 18 and 75 years of age) aged 18 to 75 years who have signed an informed consent (ICF) that none of the available treatment options have been effective; and\n2. Previously diagnosed relapsed\u002Frefractory neuroimmune disorders for which there are currently no effective treatments, as determined by the specified diagnostic criteria, including:\n\nPatients with AQP4 antibody-positive optic neuromyelitis optica (NMOSD) who meet the 2015 IPND NMOSD diagnostic criteria and meet one of the following requirements:\n\nTreatment with at least one immunosuppressive agent for at least one year, or intolerance of immunosuppressive therapy with suboptimal symptom control; At least 2 relapses in the last 12 months or 3 relapses in the last 24 months and at least 1 relapse in the 12 months prior to screening.\n\nPatients with myasthenia gravis (MG) who meet the 2020 MGFA diagnostic criteria for a total MG-ADL score of ≥6 with a relevant antibody-positive MGFA classification II-IV and meet one of the following requirements:\n\nHave used standardized treatment with at least one immunosuppressive agent for more than 1 year and have one of the following poorly controlled conditions: 1) persistent weakness that interferes with daily life 2) exacerbation of MG symptoms and\u002For crisis episodes despite standardized treatment, and 3) inability to tolerate immunosuppressive therapy; Requires plasma exchange or intravenous gammaglobulin maintenance therapy.\n\nPatients with chronic inflammatory demyelinating polyneuropathy (CIDP) who meet the 2021 EAN\u002FPNS diagnostic criteria of an INCAT Disability Scale total score of 2-9 positive for relevant antibodies and meet one of the following requirements:\n\nStandardized use of at least one first-line therapy for more than 3 months (cortisol hormone therapy, gammaglobulin, or plasma exchange therapy) with poor symptom control; Inability to tolerate cortisol hormone, gammaglobulin, and plasma exchange therapy because of side effects or other conditions.\n\nPatients with a clinical diagnosis of refractory antibody-positive idiopathic inflammatory myopathy who meet the 2017 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for a diagnosis of IIM, with proximal muscle strength of at least one limb less than or equal to grade 4, and elevated creatine kinase. And meet one of the following requirements:\n\nPresence of at least one creatine enzyme (CK, AST, ALT, ALD, LDH) ≥1.5 x ULN in the screening period; or dermatomyositis with a Dermatologic Lesion Extent and Severity Index (CDASI) ≥6; or evidence of active myositis in at least one of the following: MRI, electromyography, and muscle biopsy within the last 6 months; Presence of at least 1 myositis-specific (MSA), associated antibody (MAA), or antinuclear antibody (ANA) positive; Treatment with corticosteroids for at least 1 month and standardized treatment with at least one immunosuppressant\u002Fmodulator (e.g., azathioprine, methotrexate, merti-macrolide, cyclosporine, tacrolimus, cyclophosphamide, leflunomide, and intravenous gammaglobulin) for more than 3 months with poor symptom control.\n\nInability to tolerate treatment with the above traditional regimens because of side effects or other conditions;\n\nClinically confirmed diagnosis of progressive MS (including primary progressive PPMS or secondary progressive SPMS) or relapsing-remitting RMS according to the 2017 Revised McDonald's Diagnostic Criteria; and Disability Status at Screening meets an EDSS score of 2-7, inclusive.RMS subjects will be required to standardize their use of DMT prior to signing the informed consent form medications still have a clear record of meeting the following conditions:\n\n2 relapses documented within 2 years prior to screening, or\n\n1 relapse documented within 1 year prior to screening, or Positive Gd-enhanced MRI scan within 1 year prior to screening (Screening MRI scan results may be used if no documented positive Gd-enhanced scan results existed in the previous year).\n\nA clinically confirmed diagnosis of autoimmune encephalitis according to the 2016 International Autoimmune Encephalitis Diagnostic Criteria, along with all of the following requirements:\n\nPositive test for at least one relevant autoantibody; Poor symptom control or intolerance of previous standardized treatment with glucocorticoids, at least one immunosuppressant\u002Fmodulator including CD20 monoclonal antibody; Autoimmune encephalitis exacerbation within 3 months prior to signing the informed consent form; Disability status at screening meeting an mRS score of ≥2 or a CASE score of ≥4.\n\nA clinically confirmed diagnosis of MOGAD according to the 2023 International Diagnostic Criteria for MOGAD, as well as meeting all of the following requirements:\n\nPositive MOG autoantibody test by CBA method; Disability status at screening meeting an mRS score of ≥2; Poor symptom control or intolerance after prior standardized treatment with glucocorticoids, conventional immunosuppressants\u002Fmodulators, and at least one biologic agent including CD20 monoclonal antibody.\n\n3)ECOG 0 to 1 point; 4)Vital organ function assessment meets the following criteria: Blood: hemoglobin ≥ 60 g\u002FL, platelet count ≥ 30 x 109\u002FL; cardiac function: left ventricular ejection fraction (LVEF) ≥55%, ECG without obvious abnormalities; renal function: eGFR ≥30 ML\u002Fmin\u002F1.73m2; Liver function: AST and ALT ≤3.0 ULN, total bilirubin ≤2.0 ULN; Lung function: dlco ≥40% of predicted value; fvc ≥50% of predicted value; have criteria for single or venous blood collection and no other contraindications to cell collection; 5)Subjects of childbearing age with negative urine pregnancy test results and agree to use effective contraception for the duration of the trial until 1 year post-infusion; 6)The patient or his\u002Fher guardian agrees to participate in the clinical trial and signs the informed consent form, indicating that he\u002Fshe understands the purpose and procedure of the clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n1. have a contraindication or hypersensitivity to fludarabine, cyclophosphamide, and any component of the test drug;\n2. have received intravenous immunoglobulin or plasma exchange therapy or immunosorbent therapy within 4 weeks prior to retrieval;\n3. have used tacrolimus, cyclosporine, azathioprine, morphimecrolimus, mycophenolate mofetil, methotrexate, or methotrexate within 1 week prior to mono-harvesting;\n4. Treatment with neonatal Fc receptor (FcRn) antagonists (e.g., Efgartigimod, etc.) within 1 week prior to single-take;\n5. have used complement inhibitory therapy (e.g., eculizumab, etc.) within 1 week prior to single-take;\n6. Suffering from severe cardiac, hepatic, pulmonary, hematologic, or endocrine system diseases that, in the judgment of the investigator, pose a greater risk than benefit of participation in the trial;\n7. Presence of active or uncontrollable infection requiring systemic therapy within 1 week prior to screening;\n8. Previous hematopoietic stem cell transplantation or solid organ transplantation (except cornea and hair transplantation), or Grade 2 or higher acute graft-versus-host disease (GVHD) within 2 weeks prior to screening;\n9. Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) positive and peripheral blood Hepatitis B Virus (HBV) DNA titer test is greater than the normal reference value range; or Hepatitis C Virus (HCV) antibody positive and peripheral blood Hepatitis C Virus (HCV) RNA titer test is greater than the normal reference value range; or Human Immunodeficiency Virus (HIV) antibody positive; or positive syphilis test; or positive cytomegalovirus (CMV) DNA test;\n10. Have received a live vaccine within 4 weeks prior to screening;\n11. Positive pregnancy test;\n12. Patients with malignant diseases such as malignant tumors prior to screening, except adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;\n13. Patients who have participated in another clinical trial within 3 months prior to screening;\n14. Other conditions that the investigator considers unsuitable for participation in the study.","75 Years",{"count":71,"type":19},20,[73],"NA","his study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed\u002Frefractory neurologic immune disorders. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed\u002Frefractory neurologic immune disorders.",[29],"2025-05-27",{"date":78,"type":52},"2025-05-31",{"date":80,"type":52},"2025-02-28",{"date":82,"type":19},"2027-03-31",{"name":84,"class":85},"Tongji Hospital","OTHER",1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":97,"phases":4,"briefSummary":98,"conditions":99,"keywords":108,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":86},"100554663","biomarkers-in-autoimmune-disease-of-nervous-system-100554663","NCT06502015","Biomarkers in Autoimmune Disease of Nervous System","Biomarkers of Neurological Autoimmune Diseases","Inclusion Criteria:\n\n* Clinical diagnosis with autoinflammatory diseases of the nervous system, including: Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathy(IIM), multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD), ect al.\n* sex and age-matched healthy individuals\n\nExclusion Criteria:\n\n* Known history of primary immunodeficiency (innate or acquired).\n* Patients with severe central nervous system, pulmonary, or other systemic infections.\n* Patients with secondary central nervous system demyelinating lesions, such as those caused by vasculitis, systemic lupus erythematosus, and Sjögren's syndrome.\n* Patients with vascular (including hemorrhagic and ischemic), hereditary metabolic, neoplastic, or toxic diseases.\n* Pregnant or lactating women.",true,{"count":96,"type":19},50000,"OBSERVATIONAL","Neurological autoimmune diseases are a group of disorders characterized by the abnormal immune response attacking the nervous system, including the brain, spinal cord and peripheral nerves. These diseases exhibit high heterogeneity, diverse clinical presentations, and are challenging to diagnose and manage due to a lack of effective treatments. In this study, the investigators will recruit eight kinds of autoimmune diseases of nervous system including Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathy (IIM), and multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD). Through this study, the investigators aim to discover biomarkers with high sensitivity, specificity, and stability, which can support early diagnosis, disease monitoring, and personalized treatment for neurological autoimmune diseases, thereby improving the quality of life and prognosis for patients.",[29,100,101,102,103,104,105,30,106,107,28],"Neuromyelitis Optica Spectrum Disorder","Multiple Sclerosis","Guillain-Barre Syndrome","Acute Disseminated Encephalomyelitis","Autoimmune Encephalitis","Stiff-Person Syndrome","Chronic Inflammatory Demyelinating Polyradiculoneuropathy","Idiopathic Inflammatory Myopathies",[109,29,110],"Biomarker","Immune cell","2024-11-17",{"date":113,"type":52},"2024-11-20",{"date":115,"type":52},"2024-07-31",{"date":117,"type":19},"2027-07",{"name":84,"class":85},{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":69,"enrollmentInfo":127,"targetDuration":4,"studyType":20,"phases":129,"briefSummary":131,"conditions":132,"keywords":135,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":86},"100405605","early-phase-1-safety-and-efficacy-of-ct103a-cells-for-relapsedrefractory-antibody-associated-inflammatory-diseases-of-the-nervous-system-100405605","NCT04561557","Safety and Efficacy of CT103A Cells for Relapsed\u002FRefractory Antibody-associated Inflammatory Diseases of the Nervous System","An Open Label Clinical Trial to Evaluate the Safety and Efficacy of CT103A Cells for the Treatment of Relapsed\u002FRefractory Antibody-associated Inflammatory Diseases of the Nervous System","CARTinNS","Inclusion Criteria:\n\n1. Male or female subjects aged 18-75 years (including 18 and 75 years);\n2. Subjects with Relapsing\u002Frefractory Antibody-mediated inflammatory diseases of the nervous system without effective treatment, including:\n\n   1. Subjects must be diagnosed as AQP4-IgG-positive NMOSD defined by 2015 criteria of IPND NMOSD and meet the following requirements: i. At least one kind of immunosuppressant has been used for more than one year with poorly-controlled symptoms; ii. Clinical evidence of at least two relapses in the last 12 months or three relapses in the last 24 months and one relapse in the preceding 12 months before screening.\n   2. Subjects with MG with positive abnormal antibody, MG-ADL total score ≥ 6 points, MGFA classification II-IV defined by 2020 MGFA diagnostic criteria and meet the following requirement: i. At least one kind of immunosuppressant for standardized treatment for more than 1 year, and have one of the following poor control conditions: 1) continuous inability to affect daily life; 2) Exacerbation of MG symptoms and\u002For crisis attacks still occur despite standard treatment; 3) Inability to tolerate immunosuppressive therapy ii. Requires plasma exchange or maintenance therapy with IV gamma globulin\n   3. Subjects with CIDP with positive abnormal antibodies, INCAT disability scale with total score of 2-9 defined by 2021 EAN\u002FPNS diagnostic criteria and meet the following requirement: i. Standardized use of at least one first-line therapy for more than 3 months (cortisol hormone therapy, gamma globulin or plasma exchange therapy) with poorly-controlled symptoms. ii. Inability to tolerate cortisol hormones, gamma globulin, and plasmapheresis because of side effects or other conditions\n   4. Subjects were diagnosed with IIM defined by 2017 European League against Rheumatism\u002FAmerican Rheumatology (EULAR\u002FACR) conference Class criteria; At least one kind of cardiac enzymes (CK, AST, ALT, ALD, LDH) ≥1.5×ULN during the screening period, or Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) ≥6, or at least one other sign of active disease within the last 6 months: MRI, EMG, or muscle biopsy; positive serological tests for myositis-specific antibodies (MSA) or myositis-associated autoantibodies (MAA), or antinuclear antibody (ANA). and meet one of the following requirements:\n\n   i. After at least 1 month of corticosteroid therapy and standardized use of at least one immunosuppressant\u002Fmodulator (eg, azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, Cyclophosphamide, leflunomide, intravenous gamma globulin, etc.) for more than 3 months with poorly-controlled symptoms.\n\n   ii. ii. Inability to tolerate the above traditional regimens due to side effects or other conditions;\n\n   e. Subjects were diagnosed with PMS (including PPMS and SPMS) or RMS according to the 2017 revision of the McDonald diagnostic criteria；EDSS score between 2 to 7 points inclusive, at screening. Subjects with RMS should meet one of the following requirements after standard therapy: i. at least two relapses in the last two years before screening. ii. at least one relapse in the last one year before screening. iii. positive Gd-enhancing MRI in the last one year before screening.\n\n   f. Subjects were diagnosed with POEMS syndrome according to the 2021 revised IMWG diagnostic criteria and meet all of the following requirements: i. bone marrow involvement; ii. no response to traditional regimens treatment including corticosteroid, chemotherapy, protease inhibitor or inability to tolerate the above traditional regimens; iii. Have measurable lesions (refer to the 2021 revised IMWG standard) iv. VEGF \\> 2 ULN; v. ECOG score ≥1; vi. ONLS score ≥1.\n\n   g. Subjects were diagnosed with autoimmune encephalitis according to the 2016 International Diagnostic Criteria for Autoimmune Encephalitis and meet all of the following requirements: i. at least one pathogenic antibody positive; ii. previously standardized use of corticosteroid, at least one immunosuppressant\u002Fmodulator, including CD20 monoclonal antibody with poorly-controlled symptoms or intolerance; iii. onset of autoimmune encephalitis within 3 months prior to screening; iv. mRS Score ≥2 or CASE score ≥4.\n\n   h. Subjects were diagnosed with MOGAD according to the 2023 International MOGAD Diagnostic criteria and meet all of the following requirements: i. a documented positive serum MOG Ab test using a cell-based assay (CBA); ii mRS Score ≥2; iii previously standardized use of corticosteroid, at least one immunosuppressant\u002Fmodulator, including CD20 monoclonal antibody with poorly-controlled symptoms or intolerance.\n3. All acute toxic reactions resolved to baseline or ≤ grade 1 assessed using NCI-CTCAE v5.0 except the ones adjudicated by the investigator to pose no risks on subjects.\n4. Enrolled subjects must have satisfactory organ function and laboratory findings as defined by the following:i. Blood tests: absolute neutrophil count ≥ 2×109\u002FL (or normal lower limit set by the central lab of the institution), platelets ≥ 100 × 109\u002FL, and hemoglobin ≥ 100 g\u002FL; ii. Liver function: total serum bilirubin, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be ≤ 1.5x the institutional normal upper limit (ULN); iii. Kidney function: CrCl ≥ 60 ml\u002Fmin\u002F1.73m2 (according to the following Cockcroft-Gault formula); iv. Electrolytes: blood potassium ≥ 3.0 mmol\u002FL; blood calcium ≥ 2.0 mmol\u002FL, blood magnesium ≥ 0.5 mmol\u002FL; v. Coagulation function: fibrinogen ≥ 1.0 g\u002FL; APTT ≤ ULN + 10s; PT ≤ ULN + 3s.\n5. Blood oxygen saturation \\> 91% in resting state.\n6. Echocardiography suggests LVEF≥ 50%.\n7. Expected life expectancy ≥ 12 weeks as assessed by the investigator.\n8. After signing the informed consent form, subjects and their partners must be willing to use effective and reliable method of contraception, devices or medicines, within one year after CT103A cells infusion (excluding contraception safety periods).\n9. Subjects must provide written informed consent before the study begin.\n\nExclusion Criteria:\n\n1. Patients do not have adequate mononuclear cells without mobilization for CAR-T cell manufacturing.\n2. History of autoimmune hemolytic disease.\n3. History of solid organ transplantation.\n4. Patients were treated with alemtuzumab within 6 months prior to apheresis. Patients were treated with fludarabine or cladribine within 3 months prior to apheresis.\n5. Patients with Papovaviruses infection.\n6. Patients have been diagnosed with malignancies in the last 2 years prior to screening except for non-melanoma skin cancer, stage I cancers with complete resection and low risk of relapse, localized prostate cancer post-treatments, biopsy-confirmed in situ cervical cancer, or squamous epithelial lesion by PAP smear.\n7. Chronic and active hepatitis B (HBV), hepatitis C (HCV), Human Immunodeficiency Virus (HIV) infection, CMV or syphilis infections concurrently.\n8. MG crisis was not effectively controlled within 2 weeks before enrollment.\n9. Known history of primary immunodeficiency (innate or acquired).\n10. Patients with severe impaired cardiac function, including but not limited to the following: unstable angina, myocardial infarction (within 6 months before enrollment), congestive heart failure (≥Grade III by NYHA), severe ventricular arrhythmia.\n11. Cerebrovascular accidents, including transient ischemic attack or stroke history, occurred within 6 months before enrollment.\n12. Major operation or surgical treatment caused by any reason within 4 weeks before enrollment.\n13. Any serious and\u002For uncontrolled comorbidities which may interfere with the evaluation during the study in the opinion of the investigator\n14. Previous treatments: History of thymectomy within 12 months prior to CT103A infusion;\n15. History of psychoactive drug abuse and failed to withdraw, or have a history of psychiatric disorders.\n16. Prone to allergies or history of serious allergy.\n17. Pregnant or lactating women.\n18. Patients with other conditions adjudicated by the investigator as unsuitable for enrollment.\n\nCriteria for lymphodepletion and CAR-T cells infusion:\n\nBefore lymphocyte depletion and CAR-T cells infusion, patients are evaluated and those meeting the following criteria cannot be included:\n\n1. Blood tests: neutrophil count \\\u003C 2 × 109\u002FL, platelet count \\\u003C 50 × 10\\^9\u002FL;\n2. Oxygen inhalation is required to maintain blood oxygen saturation ≥ 91%;\n3. Patients have the following conditions, including but not limited to: new arrhythmia cannot be controlled by drugs; hypotension requiring pressor drugs; bacterial, fungal or viral infection requiring intravenous antibiotic treatment; creatinine clearance rate \\\u003C 50 ml\u002Fmin ;\n4. Patients require maintenance support treatment within one week to meet the criteria for lymphodepletion or CAR T cell infusion.\n5. Cell infusion is delayed \\> 7 days after lymphodepletion for any reason;\n6. Patients with other conditions adjudicated by the investigator as unsuitable for lymphodepletion or cell infusion.",{"count":128,"type":19},36,[130],"EARLY_PHASE1","Antibody-mediated inflammatory diseases of the nervous system (also known as autoimmune diseases of the nervous system) are autoimmune diseases in which autoimmune cells and immune molecules attack the nervous system as the main pathogenic mechanism. In the immune response, pathogenic antibodies acting on autoantigens of the nervous system are collectively referred to as autoantibodies of the nervous system, and antibody-mediated inflammatory diseases of the nervous system can occur in the central nervous system, peripheral nervous system, and neuromuscular junctions, and muscles. In this study, we will recruit eight kinds of autoimmune diseases of nervous system including Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathyand (IIM), multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) and POEMS Syndrome. B-cell maturation antigen (BCMA) is expressed on the surface of plasma cells, thus making it an ideal target for targeted therapies. Chimeric antigen receptor (CAR) T cells against BCMA offers another potential therapeutic option to eliminate plasma cells in patients with neurological autoimmune diseases driven by abnormal antibody who still suffer recurrent attacks from conventional treatments. In the current study, the safety and efficacy of a novel CAR-T cell therapy using CT103A cells, are evaluated in patients with relapsed\u002Frefractory antibody-mediated idiopathic inflammatory diseases.",[28,29,100,30,106,107,101,104,133,134],"Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)","POEMS Syndrome",[136,137,46,29],"Adoptive T Cell Therapy","Chimeric antigen receptor","2024-10-27",{"date":140,"type":52},"2024-10-30",{"date":142,"type":52},"2020-09-22",{"date":144,"type":19},"2027-05-31",{"name":84,"class":85},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":15,"minAge":152,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":97,"phases":4,"briefSummary":154,"conditions":155,"keywords":166,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":86},"100455749","predictors-and-prognostic-factors-of-myasthenia-gravis-outcome-100455749","NCT05214612","Predictors and Prognostic Factors of Myasthenia Gravis Outcome","Inclusion Criteria:\n\n1. Age from 16 years and older.\n2. Gender: both sexes are included.\n3. Clinical Diagnosis of MG with supporting evidence as:\n\n   1. unequivocal clinical response to pyridostigmine\n   2. decrement \\>10% in repetitive nerve stimulations study (RNS).\n4. Willingness to sample collection, imaging study and other disease-related examinations and assessments.\n\nExclusion Criteria:\n\n1. Age younger than 16 years.\n2. History of chronic psychiatric or neurological disorder other than MG that can produce weakness or fatigue.\n3. Severe systemic illness affecting life-expectancy.","16 Years",{"count":18,"type":19},"This study aims to characterize the clinical features, frequency of different subgroups of MG, and identify predictors of treatment responsiveness among different subgroups of MG. The predictors are including primary outcome (percentage of changes in MG scales at baseline at time of enrollment and after 3 months) and secondary outcome (treatment-related adverse events). Also it aims to determine the frequency of patients with refractory MG.\n\nThis information will be used to understand the trends and mechanisms of disease relapse, and optimal management strategies.",[30,29,156,157,158,159,160,161,162,163,164,165],"Neuromuscular Junction Diseases","Thymoma","Thymus Hyperplasia","Nervous System Diseases","Myasthenia Gravis, Generalized","Myasthenia Gravis, Ocular","Myasthenia Gravis Crisis","Myasthenia Gravis With Exacerbation (Disorder)","Myasthenia Gravis, Adult Form","Myasthenia Gravis, Juvenile Form",[167,168,30,169],"Predictors","Prognostic factors","Outcome","2024-07-30",{"date":115,"type":52},{"date":173,"type":52},"2022-01-01",{"date":175,"type":19},"2025-03-31",{"name":177,"class":85},"Assiut University",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":20,"phases":188,"briefSummary":190,"conditions":191,"keywords":195,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":86},"100503407","phase-3-non-inferiority-study-of-rituximab-compared-to-ocrelizumab-in-relapsing-ms-100503407","NCT05834855","Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing MS","Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing Multiple Sclerosis","Noisy Rebels","Inclusion Criteria:\n\n1. Men and women aged 18 years and older\n2. A diagnosis of relapsing MS according to the 2017 revised diagnostic criteria\n3. Indication to start treatment with anti-CD20 therapy according to the treating neurologist and the relevant label in the Netherlands for treatment of relapsing MS\n4. Able to understand written and spoken Dutch or English\n5. Capable of giving signed informed consent including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n6. Screening EDSS score ≤ 6.5 .\n\nExclusion Criteria:\n\nMedical Conditions\n\n1. A known allergy or other intolerability to RTX, OCR, gadolinium-based MRI contrast agents, or corticosteroids.\n2. A diagnosis of primary progressive MS according to the diagnostic criteria.\n3. A diagnosis of not-active secondary progressive MS.\n4. Chronic infectious diseases such as tuberculosis, VZV, hepatitis virus or HIV, as well as hepatitis B surface antigen positivity and\u002For hepatitis C PCR positivity verified at screening visit.\n5. A history of proven inflammatory bowel disease such as M. Crohn or ulcerative colitis\n6. Prior or current psychiatric illness, mental deficiency or cognitive dysfunction influencing the patient ability to make an informed consent or comply with the treatment and follow-up phases of this protocol.\n7. Cardiac disease that makes treatment with OCR or RTX contra-indicated as stated by the most recent SmPC\n8. Active malignancy or prior history of malignancy that makes treatment with OCR or RTX contra-indicated as stated by the most recent SmPC.\n9. WBC \\\u003C 1.5 x 109\u002FL if not caused by a reversible effect of documented ongoing medication. If caused by a reversible effect of documented ongoing medication the WBC count must be \\> 1,5 x 109\u002FL before start of study treatment.\n10. Platelet (thrombocyte) count \\\u003C 100 x 109\u002FL\n11. ALAT and\u002For ASAT more than 2 times the upper normal reference limit (ULN)\n12. Serum creatinine \\> 200 μmol\u002FL\n13. Serum bilirubin \\> ULN\n14. Serum IgG \\\u003C LLN\n15. Pregnant or breast-feeding women\n16. Women of childbearing potential (WOCBP) not able or willing to use highly effective methods of birth control per ICH M3 (R2) that result in failure rate of ≤ 1% per year when used consistently and correctly for the duration of the study OR until 3 months after last dose administered.\n17. History of serious or life-threatening infusion reaction to OCR or RTX\n18. Treatment with glucocorticoids or ACTH within one month prior to start of study treatment\n\n    Prior\u002FConcomitant Therapy\n19. Previous use of second line MS-therapies cladribine, RTX, alemtuzumab, OCR, ofatumumab, hematopoietic stem cell therapy (HSCT) or other immunosuppression therapies with long lasting effects. Mitoxantrone is allowed if used \\> 1 year before enrolment. If any of these medications have been used for indications other than MS, patients can be included if the medications have not been used the year before enrolment. Previous treatment with natalizumab is allowed if the reason to switch was disease activity (so not allowed in for example cases that switch from natalizumab to anti-CD20 therapy because of JCV positivity).\n20. Concomitant use of systemic immunosuppressive medication (except corticosteroids for symptomatic treatment of relapses).\n\n    Prior\u002FConcurrent Clinical Study Experience\n21. Currently enrolled in another investigational device or drug study, or less than 30 days since ending of another investigational device or drug study (s), or receiving other investigational treatment(s). Patients participating in a purely observational studies will be allowed to participate.\n\n    Lifestyle\n22. Current alcohol or drug dependencies.\n\n    Diagnostic assessments\n23. Presence of metallic objects implanted in the body, that would preclude the ability of the patient to safely have MRI exams.\n24. Not willing to undergo MRI scans with i.v. gadolinium injections",{"count":187,"type":19},200,[189],"PHASE3","Rationale: Ocrelizumab is widely and effectively used to treat relapsing multiple sclerosis (RMS). Phase II studies and data from large patient cohorts indicate that rituximab, another anti-CD20 monoclonal antibody, is probably equally effective and safe as ocrelizumab in the treatment of RMS. An advantage of rituximab is a considerably lower price. Therefore we will start a study aimed at demonstrating non-inferiority of rituximab compared to ocrelizumab in RMS. If non-inferiority of rituximab can be shown, important reductions in the cost of treatment of RMS will be possible, without loss of efficacy.\n\nObjective: Evaluating the efficacy and safety of ritixumab compared to ocrelizumab in the treatmens of RMS.\n\nStudy design: Randomized double blind multi-centre non-inferiority study of rituximab compared to ocrelizumab in 200 patients with RMS. The trial duration will be 30 months\n\nStudy population: The study population consists of 200 adult RMS patiens with an indication to start anti-CD20 monoclonal antibody treatment.\n\nIntervention: Patients will be randomized 1:1 into the standard group (ocrelizumab treatment) or the experimental group (rituximab treatment).\n\nMain study parameters: To conclude non-inferiority of rituximab there will be one primary endpoint: the proportion of patients free of inflammatory disease activity (defined as: new or enlarged T2 lesions) between week 24 (M6) and week 96 (M24) of treatment in each arm. Secondary trial endpoints are presence and number of clinical relapses,T2 and contrast enhancing lesion volumes, brain volume and brain volume changes, disease progression (defined as clinically relevant change on any of the measures: EDSS, T25FW, 9HPT, SDMT), biochemical parameters such as lipidomics and neurofilament light (NfL), immunological parameters, safety as measured by the number of (serious) adverse events ((S)AE), quality of life (EQ-5D-L) and treatment satisfaction (TSQM) and patient reported measures of MS impact (MSIS-29) and well-being (questionnaire on physical complaints)\n\nNature and extent of the burden and risk: Patients included in this study will be treated and monitored by MRI, clinical tests and laboratory tests according to existing protocols and will not be exposed to extra or unknown risks. They will have extra annual questionnaires and larger blood samples at some time points. There is extensive experience with both rituximab and ocrelizumab as efficacious and safe treatments of RMS.",[101,192,193,29,159,194],"Multiple Sclerosis, Relapsing-Remitting","Demyelinating Autoimmune Diseases, CNS","Demyelinating Diseases",[196,197,198],"ocrelizumab","rituximab","non-inferiority","2023-04-17",{"date":201,"type":52},"2023-04-28",{"date":203,"type":19},"2023-04",{"date":205,"type":19},"2027-05",{"name":207,"class":85},"Amsterdam UMC, location VUmc"]