[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuromyelitis-optica-spectrum-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuromyelitis-optica-spectrum-disorder":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,48,77,104,129,153,181,213,235,256,294,326,354,377,398],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100644891","phase-1-a-study-of-c-car168-in-the-treatment-of-autoimmune-diseases-refractory-to-standard-therapy-100644891",false,"NCT07676266","A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy","An Exploratory Clinical Study of Anti-CD20\u002FB-cell Maturation Antigen (BCMA) Chimeric Antigen Receptor Autologous T Cell Product (C-CAR168) in the Treatment of Autoimmune Diseases Refractory to Standard Therapy","Inclusion Criteria:\n\n* 18 to 70 years old at the time of signing the Informed Consent Form (ICF).\n* Diagnosed as Multiple sclerosis (MS)\u002FNeuromyelitis Optica Spectrum Disorders (NMOSD)\u002FMyasthenia Gravis (MG)\u002FSystemic Lupus Erythematosus (SLE)\u002F Systemic Sclerosis (SSc)\u002F Immune-Mediated Necrotizing Myopathy (IMNM) according to recognized diagnostic criteria for at least 6 months.\n* Prior treatment failure with standard therapy.\n* Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function.\n\nExclusion Criteria:\n\n* Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive, Epstein-Barr Virus (EBV) DNA positive.\n* Uncontrolled active infection.\n* Live vaccine injection within 4 weeks prior to signing the ICF.\n* Major organ transplantation history or bone marrow\u002Fhematopoietic stem cell transplantation history.\n* Severe cardiovascular diseases within the past 6 months prior to screening.\n* A history of ≥ Grade 2 bleeding within 4 weeks prior to screening, or requiring long-term anticoagulants treatment.\n* Inadequate washing time for previous treatment.\n* Previously treated with CAR-T cell products or genetically modified T cell therapies.\n* Pregnant or lactating women.\n* Severe central nervous system diseases or pathological changes.\n* Malignancy history within 5 years prior to signing the ICF.\n* Any contraindication to lumbar puncture for MS or NMOSD.","ALL","18 Years","70 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is an investigator-initiated, single-center, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard therapy",[27,28,29,30,31,32],"Multiple Sclerosis (MS)","Myasthenia Gravis (MG)","Neuromyelitis Optica Spectrum Disorder","Systemic Lupus Erythematosus","Systemic Sclerosis","Immune-Mediated Necrotizing Myopathy",[34],"CD20\u002FBCMA-directed CAR-T cells","NOT_YET_RECRUITING","2026-06-24",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":21},"2026-07",{"date":43,"type":21},"2028-10",{"name":45,"class":46},"The Affiliated Hospital of Qingdao University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100635802","phase-3-efficacy-safety-pharmacokinetics-pharmacodynamics-and-immunogenicity-study-of-ravulizumab-in-chinese-adults-with-neuromyelitis-optica-spectrum-disorder-nmosd-100635802","NCT07557420","Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Study of Ravulizumab in Chinese Adults With Neuromyelitis Optica Spectrum Disorder (NMOSD)","A Phase 3b, Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Chinese Adult Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)","Key Inclusion (essential)\n\n* Diagnosis: NMOSD per 2015 international consensus criteria, and anti AQP4 antibody positive at Screening.\n* Disease activity: ≥1 attack\u002Frelapse in the past 12 months.\n* Disability: EDSS ≤7.\n* Background therapy: If on IST and\u002For oral corticosteroids, participant should be on a stable maintenance regimen prior to Screening and plan to remain stable during the study unless relapse occurs. (Detailed agent specific duration\u002Fdose rules to be confirmed at screening.)\n* Body weight: ≥40 kg.\n* Vaccinated against meningococcal infections from serogroups A, C, W, Y (and B where available) within the 3 years prior to study intervention administration on Day 1.\n\nKey Exclusion (essential)\n\n* Pregnancy\u002Flactation: Pregnant, breastfeeding, or intending to conceive during the study.\n* Infection risk: History of meningococcal disease or unresolved meningococcal disease, active systemic infection within 14 days, or fever ≥38°C within 7 days before Day 1.\n* Hypersensitivity: To murine proteins or ravulizumab excipients.\n* Serious comorbidities: Any condition that in the Investigator's judgment adds risk or interferes with participation\u002Fassessment.\n* Viral infections: Known HIV, active HBV, or active HCV.\n* Prior\u002Fconcomitant immunomodulatory treatments:\n\n  * B cell-depleting therapy (e.g., rituximab, inebilizumab) within 3 months before Screening.\n  * Mitoxantrone or satralizumab within 3 months before Screening.\n  * IVIg within 3 weeks before Screening.\n  * Any prior or current complement inhibitor.\n\nNote: Other protocol-defined criteria may apply and should be verified during full eligibility review.","130 Years",{"count":57,"type":21},21,[59],"PHASE3","The primary objective of this study is to confirm the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ravulizumab in the treatment of Chinese adults with anti-aquaporin-4 (AQP4) antibody (Ab) + neuromyelitis optica spectrum disorder (NMOSD).",[62,29],"NMOSD",[64,62,65],"Ravulizumab","Neuromyelitis optica spectrum disorder","2026-06-17",{"date":68,"type":39},"2026-06-18",{"date":70,"type":21},"2026-08-31",{"date":72,"type":21},"2028-10-31",{"name":74,"class":75},"Alexion Pharmaceuticals, Inc.","INDUSTRY",5,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":86,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100513515","registry-of-patients-with-aqp4-nmosd-treated-with-alexion-c5-inhibitor-therapies-100513515","NCT05966467","Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies","A Long-Term, Prospective, Observational, Registry of Patients With Anti-Aquaporin 4 Antibody-Positive (AQP4+) Neuromyelitis Optica Spectrum Disorder (NMOSD) Treated With Alexion Complement Component 5 (C5) Inhibitor Therapies (ALXN-C5IT)","Inclusion Criteria:\n\n* Participant is ≥ 18 years of age at the time of enrollment in the Registry.\n* Participant must have a confirmed diagnosis of AQP4+ NMOSD.\n* At the time of enrollment in the Registry, participants must be receiving treatment with ALXN-C5IT for the purpose of chronic relapse prevention in a manner consistent with the local label. Specifically, they should have received at least 1 dose of eculizumab within 4 weeks prior to enrollment or at least 1 dose of ravulizumab within 12 weeks prior to enrollment.\n* Participants must have both the following historical data available to be enrolled in the Registry: ALXN-C5IT dosing information since initiation and number and types of relapses from 1 year prior to ALXN-C5IT initiation through Registry enrollment.\n\nExclusion Criteria:\n\n* Participants currently enrolled in an interventional clinical study for the treatment of AQP4+ NMOSD in which the intervention is a drug.",{"count":85,"type":21},122,"5 Years","OBSERVATIONAL","Long-term, multicenter, multinational, observational, registry of patients with AQP4+ NMOSD that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT). The registry will also collect data on patient reported outcomes (PROs), quality of life (QoL), and targeted AQP4+ NMOSD therapies used to provide evidence on the real-world impact of ALXN-C5IT on patients with AQP4+ NMOSD.",[29,62,90],"AQP4+ NMOSD",[29,62,92,90,93,94,95],"C5 Inhibitor Therapies","Patient Registry","Alexion C5IT","Soliris","RECRUITING",{"date":68,"type":39},{"date":99,"type":39},"2024-02-01",{"date":101,"type":21},"2029-09-27",{"name":74,"class":75},33,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100454603","phase-3-a-study-to-evaluate-pharmacokinetics-efficacy-safety-tolerability-and-pharmacodynamics-of-satralizumab-in-pediatric-patients-with-aquaporin-4-antibody-positive-neuromyelitis-optica-spectrum-disorder-nmosd-100454603","NCT05199688","A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)","A Phase III, Multicenter, Open-Label, Uncontrolled Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)","SAkuraSun","Inclusion Criteria:\n\n* Age at screening 2-11 years, inclusive\n* Body weight at screening \\>=10 kg\n* For female patients of childbearing potential (postmenarchal): agreement to either remain completely abstinent (refrain from heterosexual intercourse) or to use a reliable means of contraception\n* Diagnosed as having NMOSD with AQP4 antibody seropositive status as defined by the Wingerchuk 2015 criteria Clinical evidence of at least one documented attack (including first attack) in the last year prior to screening\n* Neurological stability for \\>=30 days prior to both screening and baseline\n* Expanded Disability Status Scale (EDSS) 0 to 6.5\n* For patients receiving a baseline immunosuppressant treatment and planning to continue on these therapies, treatment must be at stable dose for 4 weeks prior to baseline\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Evidence of other demyelinating disease mimicking NMOSD\n* Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline\n* Evidence of chronic active hepatitis B or C\n* Evidence of untreated latent or active tuberculosis (TB)\n* Receipt of a live or live-attenuated vaccine within 6 weeks prior to baseline\n* History of severe allergic reaction to a biologic agent","2 Years","11 Years",{"count":115,"type":21},8,[59],"This study will primarily evaluate the pharmacokinetics of satralizumab in pediatric patients aged 2-11 years with anti-aquaporin-4 (AQP4) antibody seropositive neuromyelitis optica spectrum disorder (NMOSD). Efficacy, safety, tolerability, and pharmacodynamics will be evaluated in a descriptive manner, given the small number of patients who will be enrolled in this study.",[29,62],"2026-06-05",{"date":121,"type":39},"2026-06-09",{"date":123,"type":39},"2026-05-06",{"date":125,"type":21},"2029-09-12",{"name":127,"class":75},"Hoffmann-La Roche",13,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":47},"100478032","phase-1-ofatumumab-in-aqp4-igg-seropositive-nmosd-100478032","NCT05504694","Ofatumumab in AQP4-IgG Seropositive NMOSD","Efficacy and Safety of Ofatumumab in AQP4-IgG Seropositive NMOSD: an Open-label, Single-arm, Multicentre Prospective Pilot Study","Inclusion Criteria:\n\n* Diagnosis of NMOSD according to the 2015 International Panel Diagnostic Criteria for NMOSD with AQP4-IgG.\n* Clinical evidence of at least 2 relapses (including first attack) in past 24 months with at least 1 relapse occurring in the preceding 12 months.\n* Adults aged ≥18 years old.\n* Expanded disability status scale (EDSS) score between 0 and 7.5 (inclusive).\n* Provision of written informed consent to participate in this study.\n* Only oral corticosteroids were permitted at screening (≤10mg equivalent per day), which should be terminated within one month.\n* Effective contraception was used for female patients with fertility during the treatment or at least 3 months after stopping medication.\n\nExclusion Criteria:\n\n* Progressive neurological deterioration unrelated to relapses of NMOSD, or presence of neurological findings suspected with PML.\n* Pregnant or breastfeeding patients and those with family planning during the study period.\n* Patients participating in any other clinical therapeutic study at the screening or within 30 days of screening.\n* Patients with splenectomy or history of no spleen, and those with planned surgery (excluding minor surgery) during the study period.\n* Presence of uncontrolled severe concurrent diseases; long-term glucocorticoids or immunosuppressants use due to other autoimmune diseases, or presence of other chronic diseases that cannot receiving immunosuppression.\n* Active infection at within 4 weeks before baseline.\n* Positive for HBV or HCV.\n* Evidence of latent or active tuberculosis (TB).\n* Have received any live or live-attenuated vaccine within 6 weeks before baseline.\n* History of malignancy in past 5 years, including solid tumor, malignant hematopathy and carcinoma in situ.\n* History of severe allergic reactions to biological agents.\n* Inability to provide written informed consent.",{"count":76,"type":21},[24,138],"PHASE2","This is an open-label, single-arm, multicentre prospective pilot study to assess the efficacy and safety of ofatumumab in patients with AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) in China.",[29],[29,142,143],"Aquaporin 4","Ofatumumab","2026-01-28",{"date":146,"type":39},"2026-01-30",{"date":148,"type":39},"2022-06-28",{"date":150,"type":21},"2026-07-31",{"name":152,"class":46},"Tang-Du Hospital",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":160,"minAge":161,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":47},"100509156","observational-safety-study-in-women-with-neuromyelitis-optica-spectrum-disorder-nmosd-exposed-to-uplizna-during-pregnancy-100509156","NCT05909761","Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy","An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy","Inclusion Criteria:\n\n* Provide informed consent\n* Are a female of reproductive potential with a confirmed or suspected diagnosis of NMOSD\n* Have been exposed to UPLIZNA during pregnancy as defined by receipt of any dose during pregnancy or within 6 months preceding conception\n\nNote: Other Protocol Defined Inclusion\u002FExclusion Criteria Apply","FEMALE","15 Years",{"count":163,"type":21},60,"This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or within 6 months preceding conception. Pregnancy-related data, potential confounding factors and information related to pregnancy outcome will be collected. The schedule of office visits and all treatment regimens will be determined by the treating healthcare provider. Duration of the study is 10 years, at minimum.",[29,166],"Pregnancy Related",[29,168,169,170,171],"Pregnancy","UPLIZNA","inebilizumab","birth complications","2026-01-26",{"date":174,"type":39},"2026-01-27",{"date":176,"type":21},"2026-04-15",{"date":178,"type":21},"2032-10-31",{"name":180,"class":75},"Amgen",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":189,"targetDuration":191,"studyType":87,"phases":4,"briefSummary":192,"conditions":193,"keywords":197,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":212},"100354845","french-registry-for-monitoring-pregnancies-for-multiple-sclerosis-100354845","NCT03900221","French Registry for Monitoring Pregnancies for Multiple Sclerosis","French Registry for Monitoring Pregnancies and Children of Women With Multiple Sclerosis Within The Observatoire Français de la Sclérose en Plaque (OFSEP) Cohort","RESPONSE","Inclusion Criteria:\n\n* All groups of patients eligible to participate to the Observatoire Français de la Sclérose en Plaque (OFSEP), including :\n* Definite Multiple sclerosis (MS) according to McDonald criteria\n* Whatever the clinical course (single attack MS, relapsing-remitting MS, secondary progressive MS, primary progressive MS)\n* Radiologically Isolated Syndromes (RIS) (will be validated by the RIS expert group)\n* Clinically Isolated Syndromes (CIS)\n* Neuromyelitis optica (NMO) and NMO spectrum disorders (will be validated by the \"Neuro-optico-myélite aiguë de Devic et des syndromes neurologiques apparentés\" (NOMADMUS) expert group)\n* No age limit (patients under the age of 18 might be included, provided informed consent is obtained from the parents)\n* Ongoing pregnancy: there will be no limit in the gestational age at inclusion. Women can be included at any time before delivery, but the gestational age at inclusion will be recorded and introduced in the analyses whenever pertinent. However, neurologists and patients will be encouraged to start the study as soon as pregnancy is diagnosed.\n* Able to give informed consent\n* Able to read and\u002For understand French\n\nExclusion Criteria:\n\n* None",{"count":190,"type":21},1500,"7 Years","The influence of pregnancy on the course of multiple sclerosis (MS) has long been a controversial topic. After the publication of the first large prospective study of pregnancy and MS in 1998, counselling of women with MS has radically changed and many patients have been able to fulfill their desire of motherhood. However, there are still some challenges for the neurologist, who has to face old unanswered questions or new issues, regarding the use of disease modifying drugs (DMDs) in this period of life, effects on the short and long term outcome of the mother (in terms of relapses and disability) and the child, role of breast-feeding and locoregional analgesia.\n\nTo set up a national prospective pregnancy registry for patients with MS, nested within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort, owing to a better knowledge of interactions between MS and pregnancy-related issues (pregnancy itself, locoregional analgesia, breastfeeding, impact of using or stopping DMDs on women\u002Fchildren…)",[194,29,195,196],"Sclerosis, Multiple","Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders","Pregnancy Abnormal",[198,199,200,201,202],"Multiple sclerosis","pregnancy","disease modifying drugs","breastfeeding","loco-regional analgesia","2025-12-30",{"date":205,"type":39},"2026-01-05",{"date":207,"type":39},"2019-08-12",{"date":209,"type":21},"2036-08-12",{"name":211,"class":46},"Hospices Civils de Lyon",48,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":112,"maxAge":220,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":225,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},"100481458","phase-2-study-of-inebilizumab-in-pediatric-subjects-with-neuromyelitis-optica-spectrum-disorder-100481458","NCT05549258","Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder","An Open-Label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder","Inclusion Criteria:\n\n* Male or female participants, minimum body weight of 15 kg, age 2 to \\\u003C 18 years at the time of screening.\n* Positive serum anti-AQP4-IgG result at screening and diagnosed with NMOSD according to the criteria of Wingerchuk et al, 2015.\n* Documented history of one or more NMOSD acute relapses within the last year, or 2 or more NMOSD acute relapses within 2 years prior to screening.\n\nExclusion Criteria:\n\n* Any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the Investigational Product or interpretation of participant safety or study results.\n* Concurrent\u002Fprevious enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 published half-lives of the investigational treatment, whichever is the longer, prior to Day 1.\n* Evidence of significant hepatic, renal, or metabolic dysfunction or significant hematological abnormality (one repeat test may be conducted to confirm results within the same screening period).\n* B-cell counts \\\u003C one-half of the lower limit of normal (LLN) for age according to the central laboratory.\n* Receipt of the following at any time prior to Day 1:\n\n  1. Alemtuzumab\n  2. Total lymphoid irradiation\n  3. Bone marrow transplant\n  4. T-cell vaccination therapy\n* Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior to screening unless B-cell counts have returned to ≥ one-half the LLN.\n* Receipt of intravenous immunoglobulin (IVIG) within one month prior to Day 1.\n* Receipt of any of the following within 2 months prior to Day 1:\n\n  1. Cyclosporine\n  2. Methotrexate\n  3. Mitoxantrone\n  4. Cyclophosphamide\n  5. Tocilizumab\n  6. Satralizumab\n  7. Eculizumab\n* Receipt of natalizumab (Tysabri®) within 6 months prior to Day 1.\n* Severe drug allergic history or anaphylaxis to 2 or more food products or medicine (including known sensitivity to acetaminophen\u002Fparacetamol, diphenhydramine or equivalent antihistamine, and methylprednisolone or equivalent glucocorticoid).\n* Diagnosed with a concurrent autoimmune disease that is uncontrolled (unless approved by the medical monitor).\n* Recent receipt of live\u002Fattenuated vaccine or blood transfusion.\n\nReceipt of any of the following:\n\n1. Any live or attenuated vaccine within 4 weeks prior to Day 1 (administration of killed vaccines and nucleoside-modified mRNA-based vaccines is acceptable; the Sponsor recommends that Investigators ensure all participants are up to date on required vaccinations prior to study entry).\n2. Bacillus Calmette Guérin vaccine within one year of screening.\n3. Blood transfusion within 4 weeks prior to screening or during screening.\n\n   * Clinically significant serious active or chronic viral, bacterial, or fungal infection that requires treatment with anti-infectives, hospitalization, or, in the Investigator's opinion, represents an additional risk to the participant, within 2 months prior to Day 1.\n   * Known history of congenital or acquired immunodeficiency (e.g., due to human immunodeficiency virus \\[HIV\\] infection, splenectomy, immunosuppression-related or idiopathic T-cell deficiencies) that predisposes the participant to infection.\n   * Positive test for chronic hepatitis B infection at screening, defined as either:\n\na. Positive hepatitis B surface antigen (HBsAg), or b. Positive hepatitis B core (HBc) antibody (anti-HBc) plus negative hepatitis B surface (HBs) antibody (anti-HBs).\n\n* Positive test for hepatitis C virus antibody.\n* Negative test for varicella zoster virus (VZV)-IgG.\n* History of cancer, apart from squamous cell or basal cell carcinoma of the skin treated with documented success of curative therapy \\> 3 months prior to Day 1.\n* History of active or latent tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening, unless treatment for TB was completed per local guidelines. Participants with latent TB or a positive QuantiFERON®-TB Gold test who are actively on anti-TB treatment can enroll if they have completed at least one month of anti-TB treatment and intend to complete the full course of anti-TB treatment. Participants with an indeterminate QuantiFERON®-TB Gold test result can enroll if a repeat QuantiFERON®-TB Gold test is negative or a tuberculin skin test is negative.\n* For participants who may undergo MRI scans:\n\n  1. Unable to undergo an MRI scan (e.g., hypersensitivity to Gd-containing MRI contrast agents, implanted pacemakers, defibrillators, or other metallic objects on or inside the body that limit performing MRI scans), or\n  2. Unable to tolerate or comply with the MRI procedure.","17 Years",{"count":5,"type":21},[138],"A Phase 2, open-label, multicenter study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of inebilizumab in eligible pediatric participants 2 to \\\u003C 18 years of age with recently active neuromyelitis optica spectrum disorder (NMOSD) who are seropositive for autoantibodies against aquaporin-4 (AQP4-immunoglobulin \\[Ig\\]G).",[29],[62],"2025-12-03",{"date":228,"type":39},"2025-12-05",{"date":230,"type":39},"2023-07-03",{"date":232,"type":21},"2027-04-13",{"name":180,"class":75},19,{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":241,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":4},"100559198","phase-1-safety-and-efficacy-of-baffr-cart-for-relapsed-refractory-neuromyelitis-optica-spectrum-disorder-100559198","NCT06561009","Safety and Efficacy of BAFFR CART for Relapsed\u002F Refractory Neuromyelitis Optica Spectrum Disorder","Inclusion Criteria:\n\n1. Male or female subjects aged 18-60 years;\n2. Patients must be diagnosed as AQP4-IgG-positive NMOSD;\n3. At least one immunosuppressant has been used for over a year with poorly controlled symptoms;\n4. 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.\n5. Subjects and their partners must be willing to use effective and reliable methods of contraception, devices or medicines, within one year before BAFFR CART cells infusion.\n6. Subjects must provide written informed consent before the study begins and comply with the requirements of the study protocol.\n\nExclusion Criteria:\n\n1. Subjects have received B cell deletion treatment within 6 months before screening;\n2. Chronic and active hepatitis B (HBV), hepatitis C (HCV), Human Immunodeficiency Virus (HIV) infection, CMV or syphilis infections concurrently.\n3. Subjects with Papovaviruses infection.\n4. Subjects have received live attenuated vaccine vaccination within 8 weeks before screening; or plan to receive live vaccine vaccination within 8 weeks after treatment;\n5. History of psychoactive drug abuse and failed to withdraw, or have a history of psychiatric disorders.\n6. Pregnant or lactating women.\n7. Subjects with severe heart, liver, kidney or bone marrow function disorder.\n8. Allergic constitution or a history of severe allergies.\n9. Subjects with conditions adjudicated by the investigator as unsuitable for lymphodepletion or cell infusion.","60 Years",{"count":243,"type":21},20,[24,138],"This is an open-label, single-arm, dose-escalation study in up to 20 participants with relapsed\u002Frefractory Neuromyelitis Optica Spectrum Disorders (NMOSD). The aim is to evaluate the safety and efficacy of the treatment with BAFFR CART.",[29],"2025-05-25",{"date":249,"type":39},"2025-05-30",{"date":251,"type":21},"2025-12-01",{"date":253,"type":21},"2028-10-01",{"name":255,"class":46},"Tianjin Medical University General Hospital",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":263,"enrollmentInfo":264,"targetDuration":17,"studyType":87,"phases":4,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":128},"100440580","swiss-pediatric-inflammatory-brain-disease-registry-swiss-ped-ibraind-100440580","NCT05017142","Swiss Pediatric Inflammatory Brain Disease Registry (Swiss-Ped-IBrainD)","Swiss Pediatric Inflammatory Bain Disease Cohort Study","Inclusion Criteria:\n\nAll patients living and\u002For treated in Switzerland with an IBrainD specified in the following list diagnosed from 2005 onward and with a disease onset before the age of 18.\n\n* Written informed consent by patients (and\u002For legal representative(s), if applicable)\n* Optic Neuritis\n* Transverse Myelitis\n* Acute disseminated encephalomyelitis\n* Multiple Sclerosis\n* Neuromyelitis Optica Spectrum Disorders\n* Myelin oligodendrocyte glycoprotein antibody-associated disease\n* Anti-NMDA-R Encephalitis\n* Anti-GAD65 Associated Autoimmune Encephalitis\n* Anti-AMPAR-1\u002F2 Associated Autoimmune Encephalitis\n* Anti-Lgi-1 Associated Autoimmune Encephalitis\n* Anti-CASPR-2 Associated Autoimmune Encephalitis\n* Anti-GABAR-1\u002F2 Associated Autoimmune Encephalitis\n* Onconeuronal Antibody (Hu, Ri, Yo, Amphiphysin, CRMP-5, Ma-1, Ma-2, SOX-1) Associated Autoimmune Encephalitis\n* Hashimoto Encephalopathy\n* CNS Vasculitis\n* CNS Sarcoidosis\n* CNS Lupus\n* Rasmussen Encephalitis\n\nExclusion Criteria:\n\n* Neurological symptoms due to infectious diseases of the CNS\n* Genetic\u002Fmetabolic causes of central demyelinating diseases\n* Neurological symptoms due to Guillain-Barré-Syndrome","36 Years",{"count":265,"type":21},500,"The Swiss-Ped-IBrainD is a national patient registry that collects information on diagnosis, symptoms, treatment, and follow-up of pediatric patients with an inflammatory brain disease in Switzerland. It was first implemented in 2020 in the pediatric clinic of the university hospital in Bern. Further centers all over Switzerland opened for recruitment after that: Aarau, Basel, Bellinzona, Chur, Geneva, Lausanne, Lucerne, St. Gallen, Winterthur and Zurich. The center in Fribourg is expected open for recruitment in 2025. The registry provides data for national and international monitoring and research. It supports research on inflammatory brain diseases in Switzerland and the exchange of knowledge between clinicians, researchers, and therapists. The registry aims to improve the treatment of children with inflammatory brain diseases and optimizing their health care and quality of life.",[268,269,270,271,29,272,273,274,275,276,277,278,279,280,281,282,283,284],"Optic Neuritis","Transverse Myelitis","Acute Disseminated Encephalomyelitis","Multiple Sclerosis","Anti-NMDAR Encephalitis","Anti-GAD65 Associated Autoimmune Encephalitis","Anti-AMPAR-1\u002F2 Associated Autoimmune Encephalitis","Anti-Lgi-1 Associated Autoimmune Encephalitis","Anti-CASPR-2 Associated Autoimmune Encephalitis","Anti-GABAR-1\u002F2 Associated Autoimmune Encephalitis","Onconeuronal Antibody (Hu, Ri, Yo, Amphiphysin, CRMP-5, Ma-1, Ma-2, SOX-1) Associated Autoimmune Encephalitis","Hashimoto Encephalitis","CNS Vasculitis","CNS Sarcoidosis","CNS Lupus","Rasmussen Encephalitis","Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)","2024-12-11",{"date":287,"type":39},"2024-12-16",{"date":289,"type":39},"2020-04-14",{"date":291,"type":21},"2071-01-01",{"name":293,"class":46},"University of Bern",{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":301,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":304,"conditions":305,"keywords":314,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":47},"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":303,"type":21},50000,"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.",[306,29,271,307,270,308,309,310,311,312,313],"Autoimmune Diseases of the Nervous System","Guillain-Barre Syndrome","Autoimmune Encephalitis","Stiff-Person Syndrome","Myasthenia Gravis","Chronic Inflammatory Demyelinating Polyradiculoneuropathy","Idiopathic Inflammatory Myopathies","Autoimmune Diseases",[315,306,316],"Biomarker","Immune cell","2024-11-17",{"date":319,"type":39},"2024-11-20",{"date":321,"type":39},"2024-07-31",{"date":323,"type":21},"2027-07",{"name":325,"class":46},"Tongji Hospital",{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":334,"enrollmentInfo":335,"targetDuration":4,"studyType":22,"phases":337,"briefSummary":339,"conditions":340,"keywords":342,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":47},"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.","75 Years",{"count":336,"type":21},36,[338],"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.",[313,306,29,310,311,312,271,308,284,341],"POEMS Syndrome",[343,344,345,306],"Adoptive T Cell Therapy","Chimeric antigen receptor","B-cell maturation antigen (BCMA)","2024-10-27",{"date":348,"type":39},"2024-10-30",{"date":350,"type":39},"2020-09-22",{"date":352,"type":21},"2027-05-31",{"name":325,"class":46},{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":301,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":22,"phases":363,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":47},"100552548","efficacy-and-safety-of-calculus-bovis-sativus-cbs-for-idiopathic-inflammatory-demyelinating-disease-cbsiniidd-100552548","NCT06474520","Efficacy and Safety of Calculus Bovis Sativus (CBS) for Idiopathic Inflammatory Demyelinating Disease (CBSinIIDD)","An Open Label Clinical Trial to Evaluate the Efficacy and Safety of Calculus Bovis Sativus (CBS) for Idiopathic Inflammatory Demyelinating Disease","Inclusion Criteria:\n\n* IIDD cohort:\n\n  * Subjects are capable of understanding the purpose and risks of the study, providing informed consent and authorizing the use of confidential health information in accordance with national and local privacy regulations.\n  * Both men and women are welcome, and the age at the time of providing informed consent is 18-65 years (inclusive).\n  * All women of childbearing age and all men must use contraceptive measures during the study and for at least 30 days after the last dose of study treatment. In addition, subjects should not donate sperm or eggs during the study and for at least 30 days after the last dose of study treatment.\n  * Must be diagnosed with\n\n    ① Multiple sclerosis, meet the 2017 revised McDonald criteria, and enter the MS cohort;\n\n    ② Aquaporin Protein-4-positive (AQP4) neuromyelitis optica spectrum disease, meet the 2015 international consensus diagnostic criteria for neuromyelitis optica spectrum disease (NMOSD), and AQP4 antibody positive, enter the AQP4-NMOSD cohort;\n\n    ③ Myelin oligodendrocyte glycoprotein antibody-related disease, clinically diagnosed as MOGAD according to the 2023 international MOGAD diagnostic criteria, and positive MOG autoantibody test by cell-based-assay method;\n\n    ④ Acute disseminated encephalomyelitis, clinically diagnosed as ADEM according to the 2013 International Pediatric Multiple Sclerosis Study Group (IPMSSG) diagnostic criteria, characterized by multifocal neurological deficits, must have encephalopathy manifestations (behavioral changes and\u002For changes in consciousness that cannot be explained by fever, including irritability), and exclude other specific antibody-positive IIDD.\n  * EDSS score ≤ 4 points at baseline (visit 1).\n  * Stable neurological examination within 30 days prior to Baseline (Visit 1).\n* Healthy cohort:\n\n  * Age ≥ 18 years old when signing the informed consent form\n  * Healthy adult subjects without underlying diseases\n\nExclusion Criteria:\n\n* Any clinically significant cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, urologic, pulmonary, neurological, dermatologic, psychiatric, and renal disease or other major medical history that the investigator determines would preclude participation in the clinical trial.\n* Any untreated teratoma or thymoma at the baseline visit (randomization)\n* Other causes of symptoms, including central nervous system infection, septic encephalopathy, metabolic encephalopathy, epileptic disorders, mitochondrial disease, Klein-Levin syndrome, Creutzfeldt-Jakob disease, rheumatic disease, Reyes syndrome, or inborn errors of metabolism.\n* History of herpes simplex encephalitis within the previous 24 weeks. 1.5. Any surgical procedure within 4 weeks prior to baseline, except laparoscopic surgery or minor surgery (defined as surgery requiring only local anesthesia or conscious sedation, i.e., surgery that does not require general, neuraxial, or regional anesthesia and can be performed on an outpatient basis; e.g., toenail surgery, mole surgery, wisdom tooth extraction), excluding thymoma or teratoma removal.\n* Planned surgery during the study (except minor surgery).\n* History of severe allergic or anaphylactic reactions, or any allergic reaction that the investigator believes may be exacerbated by any component of study treatment.\n* Current or history of malignant disease, including solid tumors and hematologic malignancies (except for basal cell carcinoma and squamous cell carcinoma that have been completely resected and considered cured for at least 12 months prior to Day -1). Subjects with cancer remission for more than 5 years prior to baseline (Visit 1) may be included after discussion with the sponsor\u002Fsponsor approval.\n* A history of gastrointestinal surgery (except appendectomy or cholecystectomy performed more than 6 months before screening), irritable bowel syndrome, inflammatory bowel disease (Crohn's disease, ulcerative colitis), or other clinically significant active gastrointestinal diseases in the opinion of the investigator.\n* A history of clinically significant recurrent or active gastrointestinal symptoms (e.g., nausea, diarrhea, dyspepsia, constipation) within 90 days before screening, including the need to start symptomatic treatment (e.g., start medication for gastroesophageal reflux disease) or a change in symptomatic treatment within 90 days before screening (e.g., dose increase).\n* A history of diverticulitis or concurrent severe gastrointestinal (GI) abnormalities (e.g., symptomatic diverticular disease) because the investigator believes that this may lead to an increased risk of complications such as GI perforation.\n* A history of blood donation (1 unit or more), plasma donation, or platelet donation within 90 days before screening.\n* Active suicidal ideation within 6 months before screening, or a history of suicide attempt within 3 years before screening.\n* Based on the investigator's judgment, there are serious diseases or abnormalities in the clinical laboratory test results that prevent the patient from completing the study or participating in the study safely.\n* Pregnant or lactating, or planning to become pregnant during the study or within 3 months after the last dose of the study drug; women of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result before the start of the study.\n* The subject's mental or physical condition will hinder the evaluation of efficacy and safety.\n* Systolic blood pressure \\>150 mmHg or \\\u003C90 mmHg after sitting still for 5 minutes or before dosing at screening. If out of range, it can be measured again at screening and before dosing. If the repeated measurement value is still out of range, the subject shall not receive the drug.\n* Subjects with second or third degree atrioventricular block or sick sinus syndrome, poorly controlled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction, or significant ECG abnormalities, including corrected QT interval \\>450 msec (male) or 470 msec (female), where corrected QT interval is determined based on the Fridericia correction method, within 3 months prior to the screening visit.\n* Planned elective procedures or surgeries at any time after signing the Informed Consent Form by follow-up visit.\n* Any condition that affects the absorption of study treatment (e.g., gastrectomy).\n* History of hypersensitivity to heparin or history of heparin-induced thrombocytopenia.\n* Subjects with abnormalities in medical history, physical examination, ECG, or diagnostic laboratory tests that the investigator considers to be clinically relevant.\n* History of human immunodeficiency virus (HIV) or positive test results at screening.\n* Current infection with hepatitis C (defined as positive hepatitis C virus (HCV) antibodies and detectable HCV RNA). Subjects with positive HCV antibodies and HCV RNA below the limit of detection are eligible to participate in the study.\n* Current infection with hepatitis B (defined as positive HBsAg and\u002For positive total anti-HBc).\n* Chronic, recurrent, or severe infection (e.g., pneumonia, sepsis) within 90 days prior to baseline (visit 1).\n* History of tuberculosis (TB) diagnosis or positive latent TB test result.\n* Symptoms of bacterial, fungal, or viral infection (including upper respiratory tract infection) within 28 days prior to baseline (visit 1). Subjects with localized fungal infection (e.g., candidiasis, tinea) are eligible for rescreening after successful treatment of the infection.\n* Infection requiring hospitalization or IV anti-infective medication within 4 weeks prior to baseline visit.\n* Any live or live attenuated vaccine within 28 days prior to baseline (visit 1) or planned during the study.\n* Contraindications to all of the following salvage therapies: rituximab, intravenous immunoglobulin, high-dose corticosteroids, or IV cyclophosphamide.\n* History of or receipt of the following treatments: Total lymphoid irradiation, cladribine, T-cell or T Cell recipient vaccination, total body irradiation, or total lymphoid irradiation at any time. Stem cell transplantation at any time.\n* Abnormal laboratory values determined by the investigator to be clinically significant at Screening or Baseline (Visit 1).\n* Any of the following blood test abnormalities at Screening: a. White blood cell count \\\u003C 3.0 × 10\\^3\u002FµL. b. Absolute neutrophil count \\\u003C 2.0 × 10\\^3\u002FµL. c. Absolute lymphocyte count \\\u003C 0.5 × 10\\^3\u002FµL. d. Platelet count \\\u003C × 10 × 10\\^4\u002FµL. e. glutamic-pyruvic transaminase, glutamic oxaloacetic transaminase, or γ-glutamyl transpeptidase ≥ 3 x upper limit of normal (ULN) or bilirubin \\> 2 x ULN. f. glomerular filtration rate ≤ 60 mL\u002Fmin\u002F1.73 m2. g. Lymphocyte count \\\u003C lower limit of normal\n* Any of the following urine test abnormalities at Screening: a. β-2-microglobulin\\>0.3 μg\u002FmL. b. Albumin\u002Fcreatinine ratio\\>22.6 mg\u002Fmmol.\n* Previous participation in this study.\n* Blood donation (1 unit or more) within 90 days before screening, plasma donation within 1 week before screening, and platelet donation within 6 weeks before screening.\n* History of alcohol or drug abuse in the past year (determined by the investigator).\n* Pregnant or lactating subjects, as well as subjects planning to become pregnant or start breastfeeding at any time during the study and within 30 days after completion of study treatment.\n* Participating in a clinical trial or having participated in a clinical trial within 90 days before screening.\n* History of clinically significant suicidal thoughts or behaviors in the past 12 months as assessed by Columbia-Suicide Severity Rating Scale at screening.\n* Unwilling or unable to comply with protocol requirements.\n* The patient has obvious hearing or vision impairment, language barriers, claustrophobia, etc., which makes the patient unable to cooperate with the neuropsychological scale assessment and MRI examination.\n* The researcher or sponsor believes that there are other unknown reasons that make the subject unsuitable for inclusion.",{"count":362,"type":21},250,[364],"NA","According to the records of traditional Chinese medicine, CBS has the following functions: clearing the heart, resolving phlegm, promoting bile secretion, and calming the nerves. It can treat fever, coma, delirium, epilepsy, convulsions in children, dental caries, throat swelling, oral sores, carbuncle, and furuncle.\n\nThe significant pathophysiological process of primary inflammatory demyelinating disease of the central nervous system (hereinafter referred to as IIDD) is the activation of the immune system of the central nervous system and the enhancement of inflammation. It includes several common diseases: multiple sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD), myelin oligodendrocyte glycoprotein antibody-related disease (MOGAD), acute disseminated encephalomyelitis (ADEM), concentric sclerosis, tumor-like inflammatory demyelinating disease, etc.\n\nCombined with the inspiration brought to us by the above background research, especially bilirubin and bile acid are closely related to intestinal digestive function, and CBS is clinically effective through oral administration by subjects, the investigators speculate that CBS is likely to exert its immune, anti-inflammatory and neuroprotective effects on the brain by changing the intestinal flora and regulating the brain-gut axis. In terms of symptoms, CBS is likely to have the effect of improving the clinical symptoms of IIDD subjects and reducing disability.",[367,271,29,368,270],"Idiopathic Inflammatory Demyelinating Disease","Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease","2024-09-19",{"date":371,"type":39},"2024-09-20",{"date":373,"type":39},"2024-08-08",{"date":375,"type":21},"2029-12",{"name":325,"class":46},{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":386,"conditions":387,"keywords":388,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":47},"100507745","inebilizumab-in-acute-neuromyelitis-optica-spectrum-disorders-100507745","NCT05891379","Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders","Effectiveness and Safety of Inebilizumab in the Acute Phase of Neuromyelitis Optica Spectrum Disorders-a Multicentric, Prospective, Real Word Study","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years with anti-AQP4-IgG seropositive NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis); 2. In the acute phase of NMOSD (definition of acute phase: new neurological symptoms or aggravation of existing symptoms within 30 days before screening, lasting at least 24 hours without with fever); 3. Patients who plan to receive or are receiving intravenous methylprednisolone therapy; 4. Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 during the screening period; 5. Able and willing to give written informed consent; 6. Women of childbearing potential who agree to use adequate contraception during the study.\n\nExclusion Criteria:\n\n* 1\\. Lactating and pregnant females; 2. Participate in other interventional studies within 30 days before screening or within 5 half-lives of the investigational agent before enrollment; 3. Combined with severe mental disorders and other conditions and unable to cooperate with follow-up; 4. History of malignancies; 5. Received plasma exchange, immunoadsorption or intravenous immunoglobulin therapy within 1 month before screening; 6. Patients with negative hepatitis B surface antibody (HBsAg) and positive hepatitis B core antibody (HBcAb), or HBsAg-positive virus carriers, or patients with active tuberculosis or positive tuberculosis screening without appropriate treatment history; 7. Other situations that researchers think are not suitable to participate in this study.",{"count":385,"type":21},50,"This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders.",[29],[29,170,389],"observational study","2024-09-08",{"date":369,"type":39},{"date":393,"type":39},"2024-07-09",{"date":395,"type":21},"2025-07-31",{"name":397,"class":46},"Xuanwu Hospital, Beijing",{"id":399,"slug":400,"hasResults":11,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":334,"enrollmentInfo":406,"targetDuration":4,"studyType":22,"phases":408,"briefSummary":409,"conditions":410,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":419,"locationsCount":4},"100554306","phase-2-fcrn-antagonists-efgartigimod-for-acute-nmosd-attack-100554306","NCT06497374","FcRn Antagonists (Efgartigimod) for Acute NMOSD Attack","FcRn Antagonists (Efgartigimod) for Acute Neuromyelitis Optica Spectrum Disorders (NMOSD) Attack: a Phase 2, Randomized Controlled Trial.","FACT","Inclusion Criteria:\n\n1. Male or female, ages 18 to 75.\n2. Meet the 2015 International Panel of Experts (IPND) diagnostic criteria for neuromyelitis optica spectrum disorders.\n3. Acute EDSS nadir of 2.5-7.5, and a change of at least 0.5 points from baseline due to an acute relapse event.\n4. Confirmation of serum AQP4-IgG antibody positivity using the CBA assay.\n5. Confirmation of an acute attack of neuromyelitis optica spectrum disorders either with an acute optic neuritis and\u002For acute myelitis, defined as a worsening in the patient's signs and symptoms of neurological\u002Fvisual impairment, an increase in the EDSS score, and symptoms lasting more than 24 hours and occurring more than 1 month since the last attack. Combination of imaging and clinical evaluation will be used to assess relapse and rule out a pseudorelapse.\n6. New lesions or enhanced lesions need to be found in MRI.\n7. Subjects who were receiving immunosuppressive therapy prior to the screening period will be required to agree to discontinue immunosuppression.\n8. Treatment is stable at least 3 months.\n\nExclusion Criteria:\n\n1. Other core clinical symptoms besides optic neuritis and myelitis.\n2. Severe neuromyelitis optica spectrum disorder attack, which in the judgment of the investigator is not appropriate for this study. Severe is defined as requiring assisted ventilation or likely to require assisted ventilation during the study based on the judgment of the investigator.\n3. Subjects with total IgG levels ≤ 6 g\u002FL at screening.\n4. Subjects with a B-cell count ≤ 5% of the lower limit of normal at screening.\n5. Received high-dose intravenous methylprednisolone within 4 weeks prior to the screening period.\n6. Received intravenous immunoglobulin, plasma exchange, or immunoadsorption treatment within 4 weeks prior to the screening period.\n7. Received a vaccination within the first 4 weeks of the screening period or planned during the study.\n8. Using of a monoclonal antibody or investigational drug not mentioned above that has immunomodulatory effects within 3 months or 5 half-lives (whichever is longer) prior to the screening period.\n9. Subject is known to be allergic to any component of the study drug or any other FcRn drug or contrast medium for enhanced MRI.\n10. Subject is known to have contraindications to taking methylprednisolone (for subjects in A and B group).\n11. Subjects with clinically significant active infections (including unresolved or inadequately treated infections, including active tuberculosis) as assessed by the investigator.\n12. Subjects with positive screening tests for hepatitis B and C who have received live or live attenuated vaccine within 6 weeks prior to baseline.\n13. Subjects is known unable to taken MRI.\n14. Subjects is known to have other ophthalmic disease that affect vision as assessed by the investigator.",{"count":407,"type":21},63,[138],"NMOSD is an autoimmune disease of the central nervous system that predominantly affects the spinal cord and optic nerves. The objectives of this study are to assess the efficacy and safety of FcRn antagonists (efgartigmod) for treatment of patients with neuromyelitis optica spectrum disorders during acute phase who are anti-aquaporin-4 (AQP4) antibody-positive. The potential of efgartigimod, an IgG1 Fc fragment that competes with IgG for FcRn binding, thereby lowering IgG levels, warrants further investigation as a treatment for acute neuromyelitis optica spectrum disorders attacks. This study aims to evaluate the therapeutic potential of efgartigmod in acute NMOSD attack.",[411,29,412],"Neuromyelitis Optica","NMO Spectrum Disorder","2024-07-04",{"date":415,"type":39},"2024-07-11",{"date":417,"type":21},"2024-07-05",{"date":38,"type":21},{"name":255,"class":46}]