[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621285":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":46,"collaborators":19,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":19,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EBV-TCR-T Cell Injection","EXPERIMENTAL","Participants enrolled in this arm will receive EBV-specific T cell receptor-engineered T cells (EBV-TCR-T cell injection) administered by intravenous infusion. EBV-TCR-T cells are genetically modified T lymphocytes designed to recognize and eliminate Epstein-Barr virus-infected cells.\n\nParticipants will receive EBV-TCR-T cell infusions at predefined dose levels according to the study protocol. Infusions are administered weekly, with up to three infusions given on Day 0, Day 7, and Day 14, depending on safety and virologic response. Safety, tolerability, and preliminary efficacy will be evaluated throughout the study.",[13],"Biological: EBV-TCR-T Cell Injection",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","EBV-TCR-T cell injection consists of Epstein-Barr virus-specific T cell receptor-engineered T lymphocytes manufactured from peripheral blood mononuclear cells. These cells are genetically modified to express EBV antigen-specific T cell receptors, enabling targeted recognition and elimination of EBV-infected cells.\n\nThe EBV-TCR-T cells are administered by intravenous infusion at predefined dose levels according to the study protocol, with up to three infusions given at weekly intervals. This intervention is intended to evaluate the safety, tolerability, and preliminary efficacy of EBV-TCR-T cells in patients with EBV DNAemia following allogeneic hematopoietic stem cell transplantation.",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Daihong Liu","CONTACT","+8613681171597","daihongrm@163.com",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"Liping Dou","+8613681207138","lipingruirui@163.com",[31],{"facility":5,"status":32,"city":33,"state":19,"zip":19,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"RECRUITING","Beijing","China","CN",{"type":37,"coordinates":38},"Point",[39,40],116.39723,39.9075,{"lat":40,"lon":39},[43],{"name":5,"role":23,"phone":44,"phoneExt":19,"email":45},"86-10-66937166","301irb@sina.com",{"type":47,"investigatorFullName":22,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","Director, Department of Hematology","100621285","phase-1-exploratory-study-of-ebv-tcr-t-cell-injection-for-ebv-dnaemia-after-allogeneic-hematopoietic-stem-cell-transplantation-100621285",false,"NCT07368634","Exploratory Study of EBV-TCR-T Cell Injection for EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation","An Exploratory Clinical Study of EBV-TCR-T Cell Injection for the Treatment of EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of enrollment.\n* History of allogeneic hematopoietic stem cell transplantation.\n* Presence of Epstein-Barr virus (EBV) DNAemia confirmed by quantitative polymerase chain reaction (qPCR) in peripheral blood.\n* EBV DNAemia persisting or increasing despite standard management, as determined by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Adequate organ function as defined by the study protocol.\n* Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of EBV-associated lymphoproliferative disorder requiring immediate cytotoxic chemotherapy.\n* Active, uncontrolled infection other than EBV.\n* History of severe autoimmune disease requiring systemic immunosuppressive therapy.\n* Uncontrolled graft-versus-host disease requiring high-dose systemic corticosteroids or other immunosuppressive treatment.\n* Prior treatment with EBV-specific adoptive T cell therapy within a defined washout period.\n* Known active malignancy other than EBV-related disease that may interfere with study participation.\n* Pregnant or breastfeeding women.\n* Any medical, psychological, or social condition that, in the opinion of the investigator, would interfere with safe participation in the study.","ALL","18 Years","70 Years",{"count":60,"type":61},18,"ESTIMATED","INTERVENTIONAL",[64,65],"PHASE1","PHASE2","Epstein-Barr virus (EBV) DNAemia is a common and potentially serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT) and may progress to EBV-associated lymphoproliferative disorders. Current treatment options are limited, and effective immune-based therapies are still needed.\n\nThis is an investigator-initiated, exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of EBV-specific T cell receptor-engineered T cells (EBV-TCR-T cell injection) in patients with EBV DNAemia after allo-HSCT. Eligible participants will receive intravenous infusions of EBV-TCR-T cells at escalating dose levels. Safety outcomes, EBV-DNA clearance, and preliminary efficacy will be assessed, along with pharmacokinetic and pharmacodynamic characteristics of the infused cells.",[68,69],"Epstein-Barr Virus Infection","Post-Transplant Lymphoproliferative Disorder",[71,72,73],"EBV DNAemia","TCR-T Cell Therapy","Dose Escalation Study","2026-01-26",{"date":76,"type":77},"2026-01-28","ACTUAL",{"date":79,"type":77},"2025-06-01",{"date":81,"type":61},"2027-06-01",{"name":22,"class":6},1]