[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644891":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":22,"locations":33,"responsibleParty":49,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":11,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":79,"overallStatus":81,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"The Affiliated Hospital of Qingdao University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"C-CAR168 Autologous C-CAR168 administered by intravenous (IV) infusion","EXPERIMENTAL",null,[13],"Biological: CD20\u002FBCMA-directed CAR-T cells Autologous 2nd generation",[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],[21],"C-CAR168",[23,28],{"name":24,"role":25,"phone":26,"phoneExt":11,"email":27},"Min Liu, MD","CONTACT","17853297267","liumin1968@yeah.net",{"name":29,"role":25,"phone":30,"phoneExt":31,"email":32},"Bin Liu, MD","18661806287","053282919030","Binliu72314@163.com",[34],{"facility":5,"status":11,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Qingdao","Qindao, Shandong","266003","China","CN",{"type":41,"coordinates":42},"Point",[43,44],120.38042,36.06488,{"lat":44,"lon":43},[47,48],{"name":24,"role":25,"phone":26,"phoneExt":11,"email":27},{"name":29,"role":25,"phone":30,"phoneExt":31,"email":32},{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[52],{"name":53,"class":54},"Shanghai AbelZeta Ltd.","INDUSTRY","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":66,"type":67},18,"ESTIMATED","INTERVENTIONAL",[70],"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",[73,74,75,76,77,78],"Multiple Sclerosis (MS)","Myasthenia Gravis (MG)","Neuromyelitis Optica Spectrum Disorder","Systemic Lupus Erythematosus","Systemic Sclerosis","Immune-Mediated Necrotizing Myopathy",[80],"CD20\u002FBCMA-directed CAR-T cells","NOT_YET_RECRUITING","2026-06-24",{"date":84,"type":85},"2026-06-30","ACTUAL",{"date":87,"type":67},"2026-07",{"date":89,"type":67},"2028-10",{"name":5,"class":6},1]