[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535254":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":55,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":30,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":86,"overallStatus":38,"whyStopped":30,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"RenJi 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],[22],{"name":23,"affiliation":24,"role":25},"Nan Shen, MD & PhD","Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong University","PRINCIPAL_INVESTIGATOR",[27,32],{"name":23,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","+86-21-63260477",null,"nanshensibs@gmail.com",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Huihua Ding, MD","+86-21-53882280","dinghuihua@outlook.com",[37],{"facility":24,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Shanghai","Shanghai Municipality","200001","China","CN",{"type":45,"coordinates":46},"Point",[47,48],121.45806,31.22222,{"lat":48,"lon":47},[51,52,53,54],{"name":23,"role":28,"phone":29,"phoneExt":30,"email":31},{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},{"name":23,"role":25,"phone":30,"phoneExt":30,"email":30},{"name":33,"role":25,"phone":30,"phoneExt":30,"email":30},{"type":56,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[58],{"name":59,"class":60},"AbelZeta Inc.","INDUSTRY","100535254","phase-1-a-study-of-c-car168-in-the-treatment-of-autoimmune-diseases-refractory-to-standard-therapy-100535254",false,"NCT06249438","A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy","An Exploratory Clinical Study of Cluster of Differentiation Antigen 20(CD20)\u002FAnti-B-cell Maturation Antigen(BCMA) Chimeric Antigen Receptor Autologous T Cell Product (C-CAR168) in the Treatment of Autoimmune Diseases Refractory to Standard Therapy","CAR-AID","Inclusion Criteria:\n\n* 18 to 70 years old at the time of signing the Informed Consent Form (ICF).\n* Diagnosed as SLE\u002FImmune-Mediated Necrotizing Myopathy (IMNM)\u002FNeuromyelitis Optica Spectrum Disorders (NMOSD)\u002FMultiple Sclerosis (MS)\u002FMyasthenia Gravis (MG)\u002FSystemic Sclerosis (SSc) according to recognized diagnostic criteria for at least 6 months.\n* Remains disease active or relapses after treatment with standard of care therapy for at least 8 weeks with the dose stable for more than 2 weeks; patients should have been treated with at least two immunosuppressants (including immunosuppressants, biologics, and disease-modifying drug (DMD) ).\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* ≥ Grade 2 bleeding within the past 30 days 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.","ALL","18 Years","70 Years",{"count":73,"type":74},30,"ESTIMATED","INTERVENTIONAL",[77],"PHASE1","This is an investigator-initiated, multicenter, 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",[80,81,82,83,84,85],"Systemic Lupus Erythematosus (SLE)","Immune-mediated Necrotizing Myopathy (IMNM)","Neuromyelitis Optica Spectrum Disorders (NMOSD)","Multiple Sclerosis (MS)","Myasthenia Gravis","Systemic Sclerosis (SSc)",[17],"2025-07-21",{"date":89,"type":90},"2025-07-25","ACTUAL",{"date":92,"type":90},"2024-03-20",{"date":94,"type":74},"2040-03",{"name":5,"class":6},1]