[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591601":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":42,"collaborators":11,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":11,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":11,"enrollmentInfo":53,"targetDuration":11,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":11,"overallStatus":62,"whyStopped":11,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"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","After signing the informed consent form, eligible subjects will receive an infusion of UTAA91 injection. Blood samples will be collected from the subjects before and after the infusion for the evaluation of pharmacokinetics, pharmacodynamics, immunogenicity, and safety.",[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":41,"phoneExt":11,"email":24},"+8613995671635",{"type":43,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100591601","early-phase-1-clinical-study-on-the-treatment-of-refractory-rheumatoid-arthritis-with-utaa91-injection-100591601",false,"NCT06982547","Clinical Study on the Treatment of Refractory Rheumatoid Arthritis With UTAA91 Injection","Clinical Study on the Treatment of Refractory Moderate - to - Severe Active Rheumatoid Arthritis 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 at least 3 months.\n* Subjects with refractory moderate - to - severe active rheumatoid arthritis who have failed standard treatment or lack effective therapeutic options.\n* Meet 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 have 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* Subjects with positive results in virus\u002Fsyphilis tests.\n* Severe cardiac diseases or unstable systemic diseases.\n* Active or uncontrollable infections requiring systemic treatment within 7 days before administration; evidence of central nervous system invasion at screening.\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 before screening.\n* Subjects who participated in other clinical studies within 1 month before screening.\n* Other conditions deemed unsuitable for enrollment by the investigator.","ALL","18 Years",{"count":54,"type":55},24,"ESTIMATED","INTERVENTIONAL",[58],"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 refractory moderate - to - severe active rheumatoid arthritis.",[61],"Rheumatoid Arthritis (RA)","NOT_YET_RECRUITING","2025-05-13",{"date":65,"type":66},"2025-05-21","ACTUAL",{"date":68,"type":55},"2025-06",{"date":70,"type":55},"2040-06",{"name":5,"class":6},1]