[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"USWM CT, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":61},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,32],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":18,"phases":4,"briefSummary":19,"conditions":20,"keywords":4,"overallStatus":23,"whyStopped":4,"lastUpdateSubmitDate":24,"lastUpdatePostDateStruct":25,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":28,"locationsCount":31},"100563546","expanded-access-protocol-eap-for-nonconforming-nc-afami-cel-100563546",false,"NCT06617572","Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel","Expanded Access Protocol for Product Which Does Not Conform to the TECELRA® (Afamitresgene Autoleucel, Suspension for Intravenous Infusion) Commercial Release Specification","Inclusion Criteria:\n\n* Patient must provide written informed consent prior to participating in this protocol\n* Patient must have been prescribed TECELRA®\n* Patient's commercially manufactured product does not meet the commercial release specification\n* Repeat manufacture is not feasible or is not clinically appropriate per Investigator assessment in consultation with per consultation with USWM CT\n* Repeat leukapheresis is not feasible or is not clinically appropriate per Investigator assessment\n* The Investigator has confirmed a favorable benefit:risk profile, following sponsor evaluation of the NC afami-cel, and deems proceeding with treatment under this EAP is in the best interest of the patient\n* Patient deemed medically fit and stable to receive NC afami-cel per Investigator assessment\n* Female patients with reproductive potential must have a negative serum or urine pregnancy test within 7 days of initiating lymphodepleting chemotherapy\n\nExclusion Criteria:\n\n* Patient has contraindication(s) as per the TECELRA® USPI\n* Do not use TECELRA® in adults who are heterozygous or homozygous for HLA-A\\*02:05P","ALL","18 Years","EXPANDED_ACCESS","The purpose of this expanded access protocol (EAP) is to provide controlled access to Afamitresgene autoleucel, suspension for intravenous infusion that does not meet the commercial release specification (NC afami-cel). This EAP will be conducted at authorized treatment centers where TECELRA® is being administered and where the EAP is approved to be conducted. Patients who are prescribed TECELRA® , sign the informed consent form, and meet all entry criteria will be eligible to participate in this protocol.",[21,22],"Synovial Sarcoma","Myxoid Liposarcoma","AVAILABLE","2026-08-10",{"date":26,"type":27},"2026-08-11","ACTUAL",{"name":29,"class":30},"USWM CT, LLC","INDUSTRY",11,{"id":33,"slug":34,"hasResults":11,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":4,"eligibilityCriteria":38,"healthyVolunteers":11,"sex":16,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":4,"studyType":44,"phases":45,"briefSummary":48,"conditions":49,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":24,"lastUpdatePostDateStruct":54,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":60},"100488618","phase-1-spearhead-3-pediatric-study-100488618","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.","2 Years","21 Years",{"count":42,"type":43},20,"ESTIMATED","INTERVENTIONAL",[46,47],"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.",[21,50,51,52],"Malignant Peripheral Nerve Sheath Tumor (MPNST)","Neuroblastoma (NBL)","Osteosarcoma","RECRUITING",{"date":26,"type":27},{"date":56,"type":27},"2023-09-01",{"date":58,"type":43},"2038-07-30",{"name":29,"class":30},10,""]