[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590709":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":29,"responsibleParty":45,"collaborators":18,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":18,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":18,"enrollmentInfo":56,"targetDuration":18,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":18,"overallStatus":69,"whyStopped":18,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"PersonGen BioTherapeutics (Suzhou) Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"UTAA91 injection","EXPERIMENTAL","Infusion of UTAA91 injection in subjects screened after signing informed consent.",[13],"Biological: UTAA91 injection",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"BIOLOGICAL",[9],null,[20],{"name":21,"affiliation":22,"role":23},"Jian Wu, Doctor","The First Affiliated Hospital of Soochow University","PRINCIPAL_INVESTIGATOR",[25],{"name":21,"role":26,"phone":27,"phoneExt":18,"email":28},"CONTACT","15358805676","njwujian@163.com",[30],{"facility":22,"status":18,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Suzhou","Jiangsu","215000","China","CN",{"type":37,"coordinates":38},"Point",[39,40],120.59538,31.30408,{"lat":40,"lon":39},[43],{"name":21,"role":26,"phone":44,"phoneExt":18,"email":28},"+86-15358805676",{"type":46,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100590709","early-phase-1-early-clinical-study-of-utaa91-injection-for-the-treatment-of-relapsedrefractory-autoimmune-diseases-100590709",false,"NCT06970951","Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed\u002FRefractory Autoimmune Diseases","A Single-Arm, Open-Label, Single-Center Investigator-Initiated Early-Stage Clinical Study for Relapsed\u002FRefractory (R\u002FR) Autoimmune Diseases","Inclusion Criteria\n\n1. Age ≥ 18 years (including the cut - off value), with no restrictions on gender.\n2. Expected survival time ≥ 3 months.\n3. Subjects with relapsed\u002Frefractory autoimmune diseases who have failed standard treatment or lack effective treatment options, including but not limited to rheumatoid arthritis, systemic sclerosis, systemic lupus erythematosus, idiopathic inflammatory myopathies, Sjögren's syndrome, connective tissue disease - related interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc.\n4. Liver and kidney functions and cardiopulmonary functions meet the requirements.\n5. No severe mental disorders.\n6. Able to understand this trial and have signed the informed consent form.\n\nExclusion Criteria\n\n1. Malignant tumors other than relapsed\u002Frefractory autoimmune diseases (R\u002FR AID) within 5 years before screening.\n2. Subjects with positive virus and\u002For syphilis tests.\n3. Presence of severe heart disease or unstable systemic diseases.\n\n5\\. Presence of active or uncontrollable infections requiring systemic treatment.\n\n6\\. Pregnant or breastfeeding women, as well as female subjects who plan to become pregnant within 2 years after cell infusion or male subjects whose partners plan to become pregnant within 2 years after their cell infusion.\n\n7\\. Subjects who have received CAR - T therapy or other gene - modified cell therapies before screening.","ALL","18 Years",{"count":57,"type":58},15,"ESTIMATED","INTERVENTIONAL",[61],"EARLY_PHASE1","This clinical trial is designed as a single - arm, open - label, single - center, investigator - initiated early - phase clinical study. The primary objective is to evaluate the safety of UTAA91 injection in treating subjects with relapsed\u002Frefractory autoimmune inflammatory diseases (AID).",[64,65,66,67,68],"Systemic Lupus Erythematosus","Rheumatoid Arthritis","Dry Syndrome","Idiopathic Inflammatory Myopathies","Systemic Sclerosis","NOT_YET_RECRUITING","2025-05-06",{"date":72,"type":73},"2025-05-14","ACTUAL",{"date":75,"type":58},"2025-05-18",{"date":77,"type":58},"2027-04-30",{"name":5,"class":6},1]