[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sjogrens-disease-with-dry-eyes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sjogrens-disease-with-dry-eyes":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"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":20,"type":21},6,"ESTIMATED","INTERVENTIONAL",[24],"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).",[27,28,29,30,31],"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":35,"type":36},"2026-04-22","ACTUAL",{"date":38,"type":21},"2026-09-01",{"date":40,"type":21},"2043-02-01",{"name":42,"class":43},"Gustave Roussy, Cancer Campus, Grand Paris","OTHER"]