[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564735":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":31,"responsibleParty":33,"collaborators":35,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":31,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":31,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":61,"whyStopped":31,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":31},{"fullName":5,"class":6},"Bioray Laboratories","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BCMA CART Group","EXPERIMENTAL","1.0-4.0×10\\^6 CAR- Tcells\u002Fkg",[13],"Drug: Universal BCMA-CD19 CART",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Universal BCMA-CD19 CART","1.0-4.0×10\\^6 CAR-T cells\u002Fkg",[9],[21],"BRL-302",[23],{"name":24,"affiliation":25,"role":26},"Xiaohui Wang, PhD","Wenzhou Medical University Affiliated Ophthalmology Hospital","STUDY_CHAIR",[28],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","18701533866",null,"xiaoxiao512006@163.com",{"type":34,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[36],{"name":25,"class":37},"UNKNOWN","100564735","phase-1-the-safety-and-efficacy-of-universal-car-t-cells-targeting-bcma-in-the-treatment-of-refractory-nmosd-100564735",false,"NCT06633042","The Safety and Efficacy of Universal CAR-T Cells Targeting BCMA in the Treatment of Refractory NMOSD","The Safety and Efficacy of Universal CAR-T Cells Targeting BCMA in the Treatment of Refractory AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disease","Inclusion Criteria:\n\n* Aged 18-65 years ; both genders eligible.\n* Meets the criteria for Refractory NMOSD.\n* Anticipated survival of ≥ 12 weeks as judged by the researcher.\n* Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication.\n* Provides written informed consent.\n\nExclusion Criteria:\n\n* History of solid organ transplantation.\n* Malignant tumor within the last two years.\n* Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.\n* Primary immunodeficiency (congenital or acquired).\n* Severe cardiac disease.\n* History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal.\n* Allergic constitution or a history of severe allergies.\n* Pregnant or breastfeeding women.","ALL","18 Years","65 Years",{"count":49,"type":50},18,"ESTIMATED","INTERVENTIONAL",[53],"PHASE1","This is an open label, Multi-center，dose-escalation study in up to 18 participants with refractory NMOSD. This study aims to evaluate the safety and efficacy of universal CAR-T Cells targeting BCMA in the Treatment of refractory NMOSD.",[56],"Autoimmune Disease",[58,59,60],"Universal BCMA CART","AQP4 Antibody Positive","RefractoryNeuromyelitis Optica Spectrum Disease","NOT_YET_RECRUITING","2024-11-07",{"date":64,"type":65},"2024-11-12","ACTUAL",{"date":67,"type":50},"2024-11-25",{"date":69,"type":50},"2025-12-12",{"name":5,"class":6}]