[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroblastoma-nbl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroblastoma-nbl":30},{"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":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28,29,30,31],"Synovial Sarcoma","Malignant Peripheral Nerve Sheath Tumor (MPNST)","Neuroblastoma (NBL)","Osteosarcoma","RECRUITING","2026-02-05",{"date":35,"type":36},"2026-02-09","ACTUAL",{"date":38,"type":36},"2023-09-01",{"date":40,"type":21},"2038-07-30",{"name":42,"class":43},"USWM CT, LLC","INDUSTRY",10]