[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488618":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":11,"locations":24,"responsibleParty":197,"collaborators":11,"id":199,"slug":200,"hasResults":201,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":11,"eligibilityCriteria":205,"healthyVolunteers":201,"sex":206,"minAge":207,"maxAge":208,"enrollmentInfo":209,"targetDuration":11,"studyType":212,"phases":213,"briefSummary":216,"conditions":217,"keywords":11,"overallStatus":27,"whyStopped":11,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":232},{"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",[25,47,64,81,102,114,130,146,163,180],{"facility":26,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Stanford University","RECRUITING","Palo Alto","California","94305","United States","US",{"type":34,"coordinates":35},"Point",[36,37],-122.14302,37.44188,{"lat":37,"lon":36},[40,45],{"name":41,"role":42,"phone":43,"phoneExt":11,"email":44},"Amy Li","CONTACT","650-788-6811","ali4@stanford.edu",{"name":46,"role":23,"phone":11,"phoneExt":11,"email":11},"Sneha Ramakrishna, MD",{"facility":48,"status":27,"city":49,"state":50,"zip":51,"country":31,"countryCode":32,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"National Institutes of Health","Bethesda","Maryland","20892",{"type":34,"coordinates":53},[54,55],-77.10026,38.98067,{"lat":55,"lon":54},[58,62],{"name":59,"role":42,"phone":60,"phoneExt":11,"email":61},"Jessica Lake","240-858-7789","Jessica.lake@nih.gov",{"name":63,"role":23,"phone":11,"phoneExt":11,"email":11},"John Glod, MD",{"facility":65,"status":27,"city":66,"state":67,"zip":68,"country":31,"countryCode":32,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Dana Farber Cancer Institute","Boston","Massachusetts","10065",{"type":34,"coordinates":70},[71,72],-71.05977,42.35843,{"lat":72,"lon":71},[75,79],{"name":76,"role":42,"phone":77,"phoneExt":11,"email":78},"Alyssa Giammanco","617-632-3027","dfbchpedicelltherapy@dfci.harvard.edu",{"name":80,"role":23,"phone":11,"phoneExt":11,"email":11},"Natalie Collins, MD",{"facility":82,"status":27,"city":83,"state":84,"zip":85,"country":31,"countryCode":32,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Washington University","St Louis","Missouri","63110",{"type":34,"coordinates":87},[88,89],-90.19789,38.62727,{"lat":89,"lon":88},[92,96,100],{"name":93,"role":42,"phone":94,"phoneExt":11,"email":95},"Tina Primeau, BA","314-454-2147","tprimeau@wustl.edu",{"name":97,"role":42,"phone":98,"phoneExt":11,"email":99},"Catie Knoerle, BA","314-747-1828","knoerlec@wustl.edu",{"name":101,"role":23,"phone":11,"phoneExt":11,"email":11},"Amy Armstrong, MD",{"facility":22,"status":27,"city":103,"state":103,"zip":68,"country":31,"countryCode":32,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"New York",{"type":34,"coordinates":105},[106,107],-74.00597,40.71427,{"lat":107,"lon":106},[110,113],{"name":21,"role":42,"phone":111,"phoneExt":11,"email":112},"212-639-6649","iglesiaf@mskcc.org",{"name":21,"role":23,"phone":11,"phoneExt":11,"email":11},{"facility":115,"status":27,"city":116,"state":117,"zip":118,"country":31,"countryCode":32,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Duke University School of Medicine","Durham","North Carolina","27710",{"type":34,"coordinates":120},[121,122],-78.89862,35.99403,{"lat":122,"lon":121},[125,129],{"name":126,"role":42,"phone":127,"phoneExt":11,"email":128},"Kris Mahadeo, MD","919-668-1180","kris.mahadeo@duke.edu",{"name":126,"role":23,"phone":11,"phoneExt":11,"email":11},{"facility":131,"status":27,"city":132,"state":133,"zip":134,"country":31,"countryCode":32,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"type":34,"coordinates":136},[137,138],-84.51439,39.12711,{"lat":138,"lon":137},[141,145],{"name":142,"role":42,"phone":143,"phoneExt":11,"email":144},"Brian Turpin, DO","513-636-2799","cancer@cchmc.org",{"name":142,"role":23,"phone":11,"phoneExt":11,"email":11},{"facility":147,"status":27,"city":148,"state":149,"zip":150,"country":31,"countryCode":32,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Children's Hospital of Philedephia","Philadelphia","Pennsylvania","19104",{"type":34,"coordinates":152},[153,154],-75.16362,39.95238,{"lat":154,"lon":153},[157,161],{"name":158,"role":42,"phone":159,"phoneExt":11,"email":160},"Shelby Brizzolara-Dove, BS","267-425-5544","CancerTrials@chop.edu",{"name":162,"role":23,"phone":11,"phoneExt":11,"email":11},"Theodore Laetsch, MD",{"facility":164,"status":27,"city":165,"state":166,"zip":167,"country":31,"countryCode":32,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Seattle Children's Hospital","Seattle","Washington","98105",{"type":34,"coordinates":169},[170,171],-122.33207,47.60621,{"lat":171,"lon":170},[174,178],{"name":175,"role":42,"phone":176,"phoneExt":11,"email":177},"CBDC Intake","206-987-2106","cbdcintake@seattlechildrens.org",{"name":179,"role":23,"phone":11,"phoneExt":11,"email":11},"Mark Fluchel, MD",{"facility":181,"status":27,"city":182,"state":183,"zip":184,"country":31,"countryCode":32,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"University of Wisconsin Cancer Center","Madison","Wisconsin","53715",{"type":34,"coordinates":186},[187,188],-89.40123,43.07305,{"lat":188,"lon":187},[191,195],{"name":192,"role":42,"phone":193,"phoneExt":11,"email":194},"Jenny Weiland, BS","608-890-8070","pedshemoncresearch@g-groups.wisc.edu",{"name":196,"role":23,"phone":11,"phoneExt":11,"email":11},"Christian Capitini, MD",{"type":198,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100488618","phase-1-spearhead-3-pediatric-study-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":210,"type":211},20,"ESTIMATED","INTERVENTIONAL",[214,215],"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.",[218,219,220,221],"Synovial Sarcoma","Malignant Peripheral Nerve Sheath Tumor (MPNST)","Neuroblastoma (NBL)","Osteosarcoma","2026-08-10",{"date":224,"type":225},"2026-08-11","ACTUAL",{"date":227,"type":225},"2023-09-01",{"date":229,"type":211},"2038-07-30",{"name":231,"class":6},"USWM CT, LLC",10]