[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634787":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":46,"collaborators":19,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":19,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":19,"overallStatus":71,"whyStopped":19,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Gustave Roussy, Cancer Campus, Grand Paris","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","The anti-CD19 CAR-T cells will be administered as a single infusion at the dose of 1x106 cells\u002Fkg body weight",[13],"Biological: anti-CD19 CAR-T cells",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","anti-CD19 CAR-T cells",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Cristina CASTILLA-LLORENTE","CONTACT","+33(0)142114355","Cristina.castilla-llorente@gustaveroussy.fr",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"Timothé DENAËS","+33(0)142115554","timothe.denaes@gustaveroussy.fr",[31],{"facility":32,"status":19,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Gustave Roussy","Villejuif","Val de Marne","94805","France","FR",{"type":39,"coordinates":40},"Point",[41,42],2.35992,48.7939,{"lat":42,"lon":41},[45],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},{"type":47,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100634787","phase-1-study-investigating-the-safety-of-anti-cd19-car-t-cells-therapy-produced-at-gustave-roussy-for-adults-with-severe-and-refractory-systemic-autoimmune-rheumatic-diseases-100634787",false,"NCT07544225","Study Investigating the Safety of Anti-CD19 CAR-T Cells Therapy Produced at Gustave Roussy for Adults With Severe and Refractory Systemic Autoimmune Rheumatic Diseases","CELL-ATTACK 1","Inclusion Criteria:\n\n* Adults aged 18-75 with ECOG PS 0-2 with written informed consent, valid health insurance, and eligibility for CAR T cell infusion are required may be included. Patients must have a treatment refractory systemic autoimmune rheumatic disease (RA, SLE, Sjögren's, SSc, or IIM) with severe, progressive activity with adequate renal function (creatinine clearance \\> 30 mL\u002Fmin)\n\nExclusion Criteria:\n\n* Patients with any significant active infection, including hepatitis B or C, HIV, or other opportunistic or recurrent infections, are excluded. Prior gene therapy, previous CAR T treatment, active cancer within 2 years, or any history of allogeneic stem cell or solid organ transplantation exclude participation. Inadequate organ function-renal, hepatic, cardiac (LVEF \\\u003C 50%), or lung function requiring oxygen- and uncontrolled comorbidities prevents inclusion. Pregnancy, breastfeeding, or refusal to use highly effective contraception for 12 months post infusion","ALL","18 Years","75 Years",{"count":59,"type":60},6,"ESTIMATED","INTERVENTIONAL",[63],"PHASE1","This is an open-label, single-dose, prospective, monocenter, Phase I interventional study (not first-in-human) to assess the safety, tolerability, and preliminary efficacy of autologous anti-CD19 CAR-T cells as an advanced therapy medicinal product in adult patients; with severe and refractory systemic autoimmune rheumatic diseases, including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), Sjogren's disease (SjD), systemic sclerosis (SSc) and idiopathic inflammatory myositis (IIM).",[66,67,68,69,70],"Rheumatoid Arthritis (RA)","Systemic Lupus Erythematosus (SLE)","Sjogren's Disease With Dry Eyes","Systemic Sclerosis (SSc)","Idiopathic Inflammatory Myositis (IIM)","NOT_YET_RECRUITING","2026-04-15",{"date":74,"type":75},"2026-04-22","ACTUAL",{"date":77,"type":60},"2026-09-01",{"date":79,"type":60},"2043-02-01",{"name":5,"class":6},1]