[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570561":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":38,"locations":46,"responsibleParty":65,"collaborators":11,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":11,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":11,"enrollmentInfo":76,"targetDuration":11,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":49,"whyStopped":11,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Miltenyi Biomedicine GmbH","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Level 1","EXPERIMENTAL",null,[13,14,15],"Biological: zamtocabtagene autoleucel","Drug: Cyclophosphamide","Drug: Fludarabine",{"label":17,"type":10,"description":11,"interventionNames":18},"Dose Level 2",[13,14,15],[20,25,30],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"BIOLOGICAL","zamtocabtagene autoleucel","chimeric antigen receptor T-cell (CAR-T) therapy",[9,17],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"DRUG","Cyclophosphamide","Lymphodepleting chemotherapy",[9,17],{"type":26,"name":31,"description":28,"armGroupLabels":32,"otherNames":11},"Fludarabine",[9,17],[34],{"name":35,"affiliation":36,"role":37},"Esther Eromosele, MD","Miltenyi Biomedicine","STUDY_DIRECTOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":11,"email":43},"Sadie Swift","CONTACT","617-218-0044","clinicaltrials@miltenyi.com",{"name":45,"role":41,"phone":42,"phoneExt":11,"email":43},"Paris Jamiel",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Froedtert Hospital and the Medical College of Wisconsin","RECRUITING","Milwaukee","Wisconsin","53226","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-87.90647,43.0389,{"lat":59,"lon":58},[62],{"name":63,"role":41,"phone":11,"phoneExt":11,"email":64},"Kiley Timler","ktimler@mcw.edu",{"type":66,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100570561","phase-1-us-zamto-cel-autoimmune-diseases-100570561",false,"NCT06708845","US Zamto-cel Autoimmune Diseases","A Phase I Multicohort Trial of Zamtocabtagene Autoleucel (Zamto-Cel) in Subjects With Severe Refractory Autoimmune Diseases","General Key Inclusion\u002FExclusion Criteria Across All Cohorts\n\nInclusion Criteria:\n\n•Confirmed diagnosis of autoimmune disease (SLE-Non-renal, SLE-LN, SSc\u002F dcSSc)\n\nExclusion Criteria:\n\n* Prior gene therapy treatment\n* Active malignancy within past 5 years\n* Significant active fungal or bacterial infection\n* History or presence of CNS lupus or other CNS disease\n* eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m\\^2\n* Total bilirubin outside the normal range (unless congenital hyperbilirubinemia such as Gilbert syndrome has been confirmed).\n\nSystemic Lupus Erythematosus-Non-renal Key Inclusion\u002FExclusion Criteria\n\nInclusion Criteria:\n\n* Positive for at least 1 of the following autoantibodies at Screening: anti- double stranded DNA or anti-Smith\n* Systemic Lupus Erythematosus Disease Activity Index-2000 score ≥ 8 AND at least 1 British Isles Lupus Assessment Group (BILAG)-2004 Class A (severe manifestation) organ scores\n* Inadequate response to glucocorticoids and to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, or obinutuzumab\n\nExclusion Criteria:\n\n* Subjects with neuropsychiatric SLE.\n* Drug-induced SLE.\n\nSystemic Lupus Erythematosus - Lupus Nephritis Key Inclusion\u002FExclusion Criteria\n\nInclusion Criteria:\n\n* Positive for at least 1 of the following autoantibodies at Screening: anti- double stranded DNA or anti-Smith\n* Confirmed LN diagnosis by kidney biopsy during screening or within the previous 6 months, with severe active phase of the disease.\n* Progressing despite maintenance on maximally tolerated doses of renin- angiotensin system (RAS) blocking agents, unless allergic to or intolerant of ACE inhibitors and ARBs\n* Inadequate response to glucocorticoids and hydroxychloroquine and at least 1 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid derivatives, belimumab, azathioprine, methotrexate, rituximab, obinutuzumab, calcineurin inhibitor (cyclosporin, tacrolimus or voclosporin)\n\nExclusion Criteria:\n\n•Evidence of Rapidly progressive glomerulonephritis (defined as a doubling of serum creatinine within 3 months prior to enrollment) or as determined by the study investigator.\n\nSystemic Sclerosis\u002FDiffuse Cutaneous Systemic Sclerosis Cohort Key Inclusion\u002F Exclusion Criteria\n\nInclusion Criteria:\n\n* Active disease defined as:\n* Modified Rodnan skin score (mRSS) ≥ 16 units, in the prior 6 months, with 1 or more of the following:\n\n  * Increase in mRSS by ≥ 3 units or 10%\n  * Involvement of 1 new body area with increase in mRSS by ≥ 2 units\n  * Involvement of 2 new body areas with increase by ≥ 1 mRSS unit OR\n* Progressive interstitial lung disease (ILD) defined as:\n\n  \\- Worsening of respiratory symptoms and an increased extent of fibrosis evaluated by high-resolution computed tomography\n* Lack of response to standard therapy (e.g., failure of ≥ 2 immunosuppressive therapies)\n\nExclusion Criteria:\n\n* \"Active\" gastric antral vascular ectasia, as evidenced by bleeding (ie, on esophagogastroduodenoscopy) in the past 6 months or as per Investigator's assessment.\n* History of SSc renal crisis within 1 year prior to Screening; presence of kidney impairment due to conditions other than SSc","ALL","18 Years",{"count":77,"type":78},48,"ESTIMATED","INTERVENTIONAL",[81],"PHASE1","AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory autoimmune diseases (SLE-Non renal, SLE-LN, SSc\u002FdcSSc) after receiving standard therapy.",[84,85,86,87],"Lupus Nephritis","Systemic Lupus Erythematosus","Systemic Sclerosis (SSc)","Diffuse Cutaneous Systemic Sclerosis",[89,90,91,92,93,94,95,96,97,98],"Chimeric antigen receptor","CAR T","Zamtocabtagene autoleucel","Autoimmune Disease","Immune System Diseases","SLE-Non renal","SLE-LN","SSc","dcSSc","Lupus","2026-06-09",{"date":101,"type":102},"2026-06-11","ACTUAL",{"date":104,"type":78},"2026-07",{"date":106,"type":78},"2028-07",{"name":5,"class":6},1]