[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619223":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":22,"locations":21,"responsibleParty":28,"collaborators":31,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":21,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":21,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":57,"overallStatus":58,"whyStopped":21,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":21},{"fullName":5,"class":6},"Huashan Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"C-CAR168","EXPERIMENTAL","Autologous C-CAR168 administered by intravenous (IV) infusion",[13],"Biological: CD20\u002FBCMA-directed CAR-T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","CD20\u002FBCMA-directed CAR-T cells","Autologous 2nd generation CD20\u002FBCMA-directed CAR-T cells, single infusion intravenously",[9],[9],null,[23],{"name":24,"role":25,"phone":26,"phoneExt":21,"email":27},"Xiangjun Chen","CONTACT","+86 21 52888159","xiangjchen@fudan.edu.cn",{"type":29,"investigatorFullName":24,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Professor of Neurology",[32],{"name":33,"class":34},"Shanghai AbelZeta Ltd.","INDUSTRY","100619223","phase-1-a-study-of-c-car168-in-the-treatment-of-central-nervous-system-autoimmune-diseases-refractory-to-standard-therapy-100619223",false,"NCT07341828","A Study of C-CAR168 in the Treatment of Central Nervous System 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 Central Nervous System 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)\u002FAutoimmune Encephalitis(AiE)\u002FStiff Person Spectrum Disorder(SPSD) 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.","ALL","18 Years","70 Years",{"count":46,"type":47},15,"ESTIMATED","INTERVENTIONAL",[50],"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 central nervous system autoimmune diseases refractory to standard therapy",[53,54,55,56],"Multiple Sclerosis (MS)","Neuromyelitis Optica Spectrum Disorders (NMOSD)","Autoimmune Encephalitis","Stiff Person Syndrome",[17],"NOT_YET_RECRUITING","2026-01-13",{"date":61,"type":62},"2026-01-15","ACTUAL",{"date":64,"type":47},"2026-02",{"date":66,"type":47},"2029-02",{"name":5,"class":6}]