[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525247":3},{"organization":4,"outcomesModule":7,"designInfo":67,"detailedDescription":73,"studyPopulation":66,"armGroups":74,"interventions":81,"overallOfficials":86,"centralContacts":90,"locations":98,"responsibleParty":119,"collaborators":66,"id":122,"slug":66,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":66,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":66,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":100,"whyStopped":66,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":66},[9],{"measure":10,"description":11,"timeFrame":12},"Adverse events","Percentage of participants with adverse events.","1 year after EBV-TCR-T treatment",[14,17,20,24,27,31,34,37,40,43,46,49,51,54,56,58,61,64],{"measure":15,"description":16,"timeFrame":12},"Changes of EBV-DNA copies number","Quantitative PCR will be used to determine viral copy numbers in peripheral blood.",{"measure":18,"description":19,"timeFrame":12},"Persistence of EBV-TCR-T cells","Quantitative PCR using primers specific for the gene encoding EBV-TCR will be used to determine the number of circulating EBV-TCR-T cells in peripheral blood post infusion.",{"measure":21,"description":22,"timeFrame":23},"Dose-limiting toxicity","Toxic effects considered by the investigators to be related to the EBV-TCR-T","28 days after EBV-TCR-T treatment",{"measure":25,"description":26,"timeFrame":23},"Maximum tolerated dose","The highest dose of DLT was seen in 1\u002F6 of the subjects",{"measure":28,"description":29,"timeFrame":30},"The proportion of EBV-DNA negative patients","The proportion of patients EBV-DNA negative after EBV-TCR-T treatment","180 days after EBV-TCR-T treatment",{"measure":32,"description":33,"timeFrame":30},"The time to EBV-DNA negative","The time from the start of therapy to EBV-DNA negative detected",{"measure":35,"description":36,"timeFrame":30},"The time to response","The time from the start of therapy to the time when patients firstly achieve complete remission or partial remission",{"measure":38,"description":39,"timeFrame":12},"The duration of response","The time from the patients firstly achieve complete remission or partial remission to progression of disease",{"measure":41,"description":42,"timeFrame":12},"The incidence of EBV-PTLD","The incidence of EBV-PTLD after EBV-TCR-T treatment",{"measure":44,"description":44,"timeFrame":45},"The overall response rate to EBV-TCR-T treatment","28,90,180,365,730 days after EBV-TCR-T treatment",{"measure":47,"description":47,"timeFrame":48},"The complete response rate to EBV-TCR-T treatment","28,90,180,365, and 730 days after EBV-TCR-T treatment",{"measure":50,"description":50,"timeFrame":12},"The incidence of EBV reactivation after EBV-TCR-T treatment",{"measure":52,"description":53,"timeFrame":23},"Maximum Plasma Concentration (Cmax) of EBV-TCR-T cells","Pharmacokinetic (PK) parameters of EBV-TCR-T cells in patients with EBV reactivation",{"measure":55,"description":53,"timeFrame":23},"Area under the plasma concentration versus time curve (AUC) of EBV-TCR-T cells",{"measure":57,"description":53,"timeFrame":23},"Half life time (T1\u002F2) of EBV-TCR-T cells",{"measure":59,"description":60,"timeFrame":23},"Concentration levels of cytokines","Concentration levels of cytokines (IL-2, IL-6, IL-10, TNF-α, IFN-γ)",{"measure":62,"description":63,"timeFrame":23},"Concentration levels of CRP","Pharmacokinetics of EBV-TCR-T cells",{"measure":65,"description":63,"timeFrame":23},"Concentration levels of ferritin",null,{"allocation":68,"interventionModel":69,"interventionModelDescription":66,"primaryPurpose":70,"observationalModel":66,"timePerspective":66,"maskingInfo":71},"NA","SINGLE_GROUP","TREATMENT",{"masking":72,"maskingDescription":66,"whoMasked":66},"NONE","EB virus (EBV) infection after allogeneic hematopoietic stem cell transplantation (HSCT) is common and can be lethal without prompt treatment. In this prospective study, HLA-A\\*02:01\u002F11:01\u002F24:02-restricted EBV-specific T cell receptor (TCR) will be introduced into the T cells of HSCT donors by ex vivo lentiviral transduction to generate EBV-TCR-T cells. An escalated dose ranging from 3×10\\^5\u002Fkg to 1×10\\^6\u002Fkg of EBV-TCR-T cells will be infused into patients with EBV infection. The safety, efficacy, pharmacokinetics and cytokine levels of allogenic EBV-TCR-T cell therapy will be evaluated.",[75],{"label":76,"type":77,"description":78,"interventionNames":79},"EBV-TCR-T cells","EXPERIMENTAL","Phase 1 trail:\n\nThe patients with EBV infection after HSCT will receive one to three infusions of donor-derived EBV-TCR-T cells, with the escalated dose ranging from 5×10\\^5\u002Fkg to 1×10\\^6\u002Fkg EBV-TCR-T cells per dose.\n\nPhase 2 trail:\n\nAccording to the PK and response data, the dose escalation phase will be carried out.",[80],"Biological: EBV-TCR-T cells",[82],{"type":83,"name":76,"description":84,"armGroupLabels":85,"otherNames":66},"BIOLOGICAL","The patients with EBV infection after HSCT will receive one to three infusions of donor-derived EBV-TCR-T cells, with the escalated dose ranging from 5×10\\^5\u002Fkg to 1×10\\^6\u002Fkg EBV-TCR-T cells per dose.",[76],[87],{"name":88,"affiliation":5,"role":89},"Daihong Liu, Doctor","PRINCIPAL_INVESTIGATOR",[91,95],{"name":88,"role":92,"phone":93,"phoneExt":66,"email":94},"CONTACT","+86 18301339032","daihongrm@163.com",{"name":96,"role":92,"phone":97,"phoneExt":66,"email":66},"Liping Dou, Doctor","+86 13681207138",[99],{"facility":5,"status":100,"city":101,"state":102,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":111,"contacts":112},"RECRUITING","Beijing","Beijing Municipality","100853","China","CN",{"type":107,"coordinates":108},"Point",[109,110],116.39723,39.9075,{"lat":110,"lon":109},[113,115,118],{"name":88,"role":92,"phone":114,"phoneExt":66,"email":94},"86-13681171597",{"name":96,"role":92,"phone":116,"phoneExt":66,"email":117},"86-13681207138","lipingruirui@163.com",{"name":88,"role":89,"phone":66,"phoneExt":66,"email":66},{"type":89,"investigatorFullName":120,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":66,"oldOrganization":66},"Daihong Liu","Director","100525247",false,"NCT06119256","Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT","Multicenter, Open Label, Single-arm Exploratory Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT","Inclusion Criteria:\n\n* Age 14-75 years, gender unlimited.\n* Diagnosed with hematologic malignancies and have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), with EBV infection after allo-HSCT.\n* Karnofsky Score ≥ 70(age ≥16y) or Lansky Score ≥ 50(age\\\u003C16y).\n* TCR-T cell donor inclusion criteria: 1) Age 8-70 years; 2) Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures; 3) ≥ 3\u002F6 HLA match with TCR-T cell recipients enrolled; 4) Lymphocyte count = (0.8\\~4) × 10\\^9\u002FL; 5) Have sufficient venous circulation, without any symptoms that do not allow blood cell isolation.\n\nExclusion Criteria:\n\n* Patients with uncontrolled active aGVHD one day before TCR-T cell infusion.\n* Patients with severe kidney disease (Cr \\> 3×normal value), liver damage (TBIL \\>2.5×upper limit of normal value, ALT and AST \\> 3×upper limit of normal value) or heart failure (NYHA heart function grade IV) one week before TCR-T cell infusion.\n* Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion.\n* Have other malignancies.\n* Have relapsed and uncontrolled hematologic malignancies.\n* Serologically positive for HIV-Ab or TAP-ab.\n* Pregnant or lactating women.\n* Anticipated to have other cell therapies in 4 week post TCR-T cell infusion.\n* Participated in any other clinical study of drugs and medical devices before 30 days of enrollment.","ALL","14 Years","75 Years",{"count":132,"type":133},12,"ESTIMATED","INTERVENTIONAL",[136],"PHASE1","This is a multi-center, single arm, open-label, phase I study to determine the safety and effectiveness of EBV-TCR-T cell immunotherapy in treating EBV virus infection after allogenic HSCT.",[139],"EBV Infection After Allogenic HSCT",[141,142],"EBV infection","allogenic HSCT","2026-03-29",{"date":145,"type":146},"2026-04-02","ACTUAL",{"date":148,"type":146},"2023-08-01",{"date":150,"type":133},"2028-12-31",{"name":5,"class":6},1]