[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ebv-dna-viremia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ebv-dna-viremia":28},{"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":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100626625","phase-1-ebv-ast-cell-therapy-for-ebv-related-diseases-after-stem-cell-transplantation-100626625",false,"NCT07438067","EBV-AST Cell Therapy for EBV-Related Diseases After Stem Cell Transplantation","A Prospective Exploratory Study of EBV-AST Cell Injection for the Treatment of EBV-Related Diseases After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. The patient must be aged 18-75 years.\n2. ust have undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT).\n3. Must have EBV-DNA viremia post-transplant, with EBV-DNA \\> 1000 copies\u002FmL (on two consecutive tests or one test \\> 10,000 copies\u002FmL).\n4. Karnofsky Performance Score (KPS) of 70 or higher.\n5. Expected survival of at least 3 months.\n6. Sufficient organ function, including renal (serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL\u002Fmin), hepatic (AST, ALT, and total bilirubin ≤ 5 × ULN), and hematologic parameters (platelets ≥ 10 × 10\\^9\u002FL, neutrophils ≥ 1.0 × 10\\^9\u002FL).\n7. HLA-matching criteria must be met for the donor\u002Frecipient.\n\nExclusion Criteria:\n\n1. Active GVHD (Grade 2 or higher) or requiring \\>0.5 mg\u002Fkg\u002Fday corticosteroids for GVHD.\n2. History of CMV viremia or disease within the past week.\n3. PTLD (Post-Transplant Lymphoproliferative Disorder) diagnosed or suspected within 1 week before infusion.\n4. Severe active infections (excluding EBV and CMV).\n5. Serious allergic reactions or contraindications to the infusion.\n6. Previous immune therapy-related adverse events of Grade 3 or higher.\n7. History of HIV, HCV, or HBV infection with an active viral load.","ALL","18 Years","75 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This exploratory clinical study focuses on the use of EBV-AST cell infusion for treating EBV-DNA viremia following allogeneic hematopoietic stem cell transplantation (Allo-HSCT). The study aims to determine the maximum tolerated dose (MTD) or optimal biological dose (OBD) of EBV-AST cells and assess their safety, tolerability, and preliminary efficacy in treating EBV-DNA viremia. The study will involve a 3+3 dose escalation design to evaluate three different dosages of EBV-AST cell infusion. The study is expected to provide important insights into the clinical application of cell-based therapies for EBV infections.",[28,29],"EBV-DNA Viremia","Post-Transplant Lymphoproliferative Disorder",[31,32,33],"EBV-DNA viremia","Allogeneic Hematopoietic Stem Cell Transplantation","EBV-AST cell infusion","RECRUITING","2026-02-26",{"date":37,"type":38},"2026-02-27","ACTUAL",{"date":40,"type":38},"2025-03-26",{"date":42,"type":21},"2028-03-26",{"name":44,"class":45},"Daihong Liu","OTHER"]