[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"antineutrophilic-cytoplasmic-antibody-anca--associated-vasculitis-aav\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:antineutrophilic-cytoplasmic-antibody-anca--associated-vasculitis-aav":57},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":4,"eligibilityCriteria":13,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":56},"100539833",false,"NCT06308978","A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease","Key Inclusion Criteria:\n\n* Age: 12 to 70 years old.\n* Diagnosis: Must have active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) confirmed by standard criteria.\n* Disease Severity: Moderate to severe, requiring at least two prior treatments that were ineffective.\n* Health Status: Adequate organ function to tolerate treatment.\n* Consent: Able to provide informed consent or assent\u002Fobtain parental consent and comply with study procedures.\n\nKey Exclusion Criteria:\n\n* Pregnancy\u002FBreastfeeding: Women must not be pregnant or nursing.\n* Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment.\n* Active Infections: No recent or ongoing serious infections.\n* Recent Cancer or Prior Cell Therapy: No active\u002Frecent malignancies, prior CAR T-cell therapy, or organ transplant.\n* Allergies: No known allergies to study treatments.\n* Weight Restriction: Must weigh at least 50 kg (110 lbs).","ALL","12 Years","70 Years",{"count":18,"type":19},244,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe active systemic lupus erythematosus (SLE) with or without nephritis, antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.",[25,26,27,28,29],"Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)","Idiopathic Inflammatory Myositis (IIM)","Systemic Sclerosis (SSc)","Systemic Lupus Erythematosus (SLE)","Lupus Nephritis",[31,32,33,34,35,36,37,38,39,40,41,42,43,44,29],"FT819","Fate Therapeutics","Idiopathic inflammatory myositis (IIM)","Systemic lupus erythematosus (SLE)","Systemic sclerosis (SSc)","Antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV)","Allogeneic CAR-T","CD19-Targeted Therapy","Cell Therapy for Autoimmune Diseases","B-Cell Depletion in Autoimmune Disease","Phase 1 Clinical Trial","Allogeneic CAR cells","Autoimmune Diseases","A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Diseases","RECRUITING","2026-05-19",{"date":48,"type":49},"2026-05-22","ACTUAL",{"date":51,"type":49},"2024-03-28",{"date":53,"type":19},"2042-09-30",{"name":32,"class":55},"INDUSTRY",21,""]