[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488618":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":11,"locations":24,"responsibleParty":189,"collaborators":11,"id":191,"slug":11,"hasResults":192,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":11,"eligibilityCriteria":196,"healthyVolunteers":192,"sex":197,"minAge":198,"maxAge":199,"enrollmentInfo":200,"targetDuration":11,"studyType":203,"phases":204,"briefSummary":207,"conditions":208,"keywords":11,"overallStatus":27,"whyStopped":11,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":223},{"fullName":5,"class":6},"USWM, LLC (dba US WorldMeds)","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Afamitresgene autoleucel","EXPERIMENTAL",null,[13],"Genetic: Afamitresgene autoleucel",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"GENETIC","Single infusion of afamitresgene autoleucel Dose: For subjects ≥10 kg to \\\u003C40 kg: starting dose of 0.025 - 0.200 x 10'9 transduced cells\u002Fkg. For subjects ≥40 kg 1.0x109 to 10x109 transduced by a single intravenous infusion",[9],[20],{"name":21,"affiliation":22,"role":23},"Fiorella Iglesias Cardenas, MD","Memorial Sloan Kettering Kids","PRINCIPAL_INVESTIGATOR",[25,46,63,77,98,110,126,142,159,172],{"facility":26,"status":27,"city":28,"state":29,"zip":30,"country":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Stanford University","RECRUITING","Palo Alto","California","94305","United States",{"type":33,"coordinates":34},"Point",[35,36],-122.14302,37.44188,{"lat":36,"lon":35},[39,44],{"name":40,"role":41,"phone":42,"phoneExt":11,"email":43},"Amy Li","CONTACT","650-788-6811","ali4@stanford.edu",{"name":45,"role":23,"phone":11,"phoneExt":11,"email":11},"Sneha Ramakrishna, MD",{"facility":47,"status":27,"city":48,"state":49,"zip":50,"country":31,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"National Institutes of Health","Bethesda","Maryland","20892",{"type":33,"coordinates":52},[53,54],-77.10026,38.98067,{"lat":54,"lon":53},[57,61],{"name":58,"role":41,"phone":59,"phoneExt":11,"email":60},"Kane Kaosaard","301-204-9057","kane.kaosaard@nih.gov",{"name":62,"role":23,"phone":11,"phoneExt":11,"email":11},"John Glod, MD",{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":31,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Dana Farber Cancer Institute","NOT_YET_RECRUITING","Boston","Massachusetts","10065",{"type":33,"coordinates":70},[71,72],-71.05977,42.35843,{"lat":72,"lon":71},[75],{"name":76,"role":23,"phone":11,"phoneExt":11,"email":11},"Natalie Collins, MD",{"facility":78,"status":27,"city":79,"state":80,"zip":81,"country":31,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Washington University","St Louis","Missouri","63110",{"type":33,"coordinates":83},[84,85],-90.19789,38.62727,{"lat":85,"lon":84},[88,92,96],{"name":89,"role":41,"phone":90,"phoneExt":11,"email":91},"Tina Primeau, BA","314-454-2147","tprimeau@wustl.edu",{"name":93,"role":41,"phone":94,"phoneExt":11,"email":95},"Catie Knoerle, BA","314-747-1828","knoerlec@wustl.edu",{"name":97,"role":23,"phone":11,"phoneExt":11,"email":11},"Amy Armstrong, MD",{"facility":22,"status":65,"city":99,"state":99,"zip":68,"country":31,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"New York",{"type":33,"coordinates":101},[102,103],-74.00597,40.71427,{"lat":103,"lon":102},[106,109],{"name":21,"role":41,"phone":107,"phoneExt":11,"email":108},"212-639-6649","iglesiaf@mskcc.org",{"name":21,"role":23,"phone":11,"phoneExt":11,"email":11},{"facility":111,"status":65,"city":112,"state":113,"zip":114,"country":31,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Duke University School of Medicine","Durham","North Carolina","27710",{"type":33,"coordinates":116},[117,118],-78.89862,35.99403,{"lat":118,"lon":117},[121,125],{"name":122,"role":41,"phone":123,"phoneExt":11,"email":124},"Kris Mahadeo, 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BS","267-425-5544","CancerTrials@chop.edu",{"name":158,"role":23,"phone":11,"phoneExt":11,"email":11},"Theodore Laetsch, MD",{"facility":160,"status":65,"city":161,"state":162,"zip":163,"country":31,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Seattle Children's Hospital","Seattle","Washington","98105",{"type":33,"coordinates":165},[166,167],-122.33207,47.60621,{"lat":167,"lon":166},[170],{"name":171,"role":23,"phone":11,"phoneExt":11,"email":11},"Mark Fluchel, MD",{"facility":173,"status":27,"city":174,"state":175,"zip":176,"country":31,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"University of Wisconsin Cancer Center","Madison","Wisconsin","53715",{"type":33,"coordinates":178},[179,180],-89.40123,43.07305,{"lat":180,"lon":179},[183,187],{"name":184,"role":41,"phone":185,"phoneExt":11,"email":186},"Jenny Weiland, BS","608-890-8070","pedshemoncresearch@g-groups.wisc.edu",{"name":188,"role":23,"phone":11,"phoneExt":11,"email":11},"Christian Capitini, MD",{"type":190,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100488618",false,"NCT05642455","SPEARHEAD-3 Pediatric Study","A Phase 1\u002F2 Open Label, Basket Study to Assess the Safety, Tolerability and Anti-Tumor Activity of Afamitresgene Autoleucel in Pediatric Subjects With MAGE-A4 Positive Tumors","Inclusion Criteria:\n\n* Subject has histologically confirmed diagnosis of any one of the following cancers: (A) Synovial Sarcoma (SS), (B) MPNST, (C) Neuroblastoma, or (D) Osteosarcoma (OS).\n* Age:\n\n(A) Synovial Sarcoma: 2 to 17 years (B) MPNST, Neuroblastoma and Osteosarcoma: 2 to 21 years\n\n* Body weight ≥ 10 kg\n* Must have previously received a systemic chemotherapy\n* Measurable disease prior to lymphodepletion according to RECIST v1.1 (or INCR, 2017 Neuroblastoma only).\n* HLA-A\\*02 positive\n* Tumor shows MAGE-A4 expression confirmed by central laboratory.\n* Performance Status:\n\n(A) Subjects ≥16: Eastern Cooperative Oncology Group (ECOG) 0 or 1 (B) Subjects 2 to 16: Lansky score ≥ 80\n\n• Subject has anticipated life expectancy of greater than 3 months in the opinion of the investigator.\n\nExclusion Criteria:\n\n* Positive for HLA-A\\*02:05 in either allele; or any A\\*02 having same protein sequence as HLA-A\\*02:05\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide.\n* History of autoimmune or immune mediated disease\n* Known central nervous system (CNS) metastases.\n* Other prior malignancy that is not considered by the Investigator to be in complete remission\n* Clinically significant cardiovascular disease\n* Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus\n* Pregnant or breastfeeding\n* Experiencing ongoing rapid disease progression that in the opinion of the Investigator significantly increases the subjects risk associated with treatment.","ALL","2 Years","21 Years",{"count":201,"type":202},20,"ESTIMATED","INTERVENTIONAL",[205,206],"PHASE1","PHASE2","This is a pediatric basket study to investigate the safety and efficacy of afamitresgene autoleucel in HLA-A\\*02 eligible and MAGE-A4 positive subjects aged 2-17 years of age with advanced cancers.",[209,210,211,212],"Synovial Sarcoma","Malignant Peripheral Nerve Sheath Tumor (MPNST)","Neuroblastoma (NBL)","Osteosarcoma","2026-02-05",{"date":215,"type":216},"2026-02-09","ACTUAL",{"date":218,"type":216},"2023-09-01",{"date":220,"type":202},"2038-07-30",{"name":222,"class":6},"USWM CT, LLC",10]