[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591600":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":41,"collaborators":11,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":11,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":11,"enrollmentInfo":52,"targetDuration":11,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":11,"overallStatus":61,"whyStopped":11,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"PersonGen BioTherapeutics (Suzhou) Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"UTAA91 injection","EXPERIMENTAL",null,[13],"Biological: UTAA91 injection",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"BIOLOGICAL","CAR-modified gamma delta T cells",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Qiubai Li, MD","CONTACT","+86-13995671635","qiubaili@hust.edu.cn",[26],{"facility":27,"status":11,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","430000","China","CN",{"type":34,"coordinates":35},"Point",[36,37],114.26667,30.58333,{"lat":37,"lon":36},[40],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},{"type":42,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100591600","early-phase-1-clinical-study-on-the-treatment-of-systemic-sclerosis-with-utaa91-injection-100591600",false,"NCT06982534","Clinical Study on the Treatment of Systemic Sclerosis With UTAA91 Injection.","Clinical Study on the Treatment of Refractory Moderate-to-Severe Active Systemic Sclerosis With UTAA91 Injection","Inclusion Criteria:\n\n* Aged ≥18 years (inclusive of the boundary value), with no restriction on gender.\n* Expected survival time of ≥3 months.\n* Refractory moderate - to - severe active systemic sclerosis that has failed standard treatment or lacks effective therapeutic options.\n* Meets the requirements for liver and kidney function, as well as cardiopulmonary function.\n* Free from severe psychiatric disorders.\n* Able to understand the trial and has signed the informed consent form.\n\nExclusion Criteria:\n\n* A history of malignant tumors other than relapsed\u002Frefractory autoimmune diseases (R\u002FR AID) within 5 years prior to screening.\n* Positive results in virology\u002Fsyphilis tests.\n* Severe cardiac diseases or unstable systemic diseases.\n* Presence of active or uncontrollable infections requiring systemic treatment, or evidence of central nervous system invasion.\n* Pregnant or breastfeeding women, female subjects planning 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* Subjects who have received CAR - T therapy or other gene - modified cell therapies prior to screening.\n* Subjects who participated in other clinical studies within 1 month prior to screening.\n* Other conditions deemed unsuitable for enrollment by the investigator.","ALL","18 Years",{"count":53,"type":54},24,"ESTIMATED","INTERVENTIONAL",[57],"EARLY_PHASE1","This clinical trial is designed as a single-arm, open-label, single-center investigator-initiated early-phase study, with the primary objective of evaluating the safety of UTAA91 injection in subjects with refractory moderate-to-severe active systemic sclerosis.",[60],"Systemic Sclerosis (SSc)","NOT_YET_RECRUITING","2025-05-13",{"date":64,"type":65},"2025-05-21","ACTUAL",{"date":67,"type":54},"2025-06",{"date":69,"type":54},"2040-01",{"name":5,"class":6},1]