[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526529":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":51,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":20,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":20,"overallStatus":36,"whyStopped":20,"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},"Experimental: EBV-TCR-T cells","EXPERIMENTAL","The patients with EBV-HLH or EBV infection will receive infusions of EBV-TCR-T cells, with the escalated dose ranging from 1×10\\^6\u002Fkg to 1×10\\^8\u002Fkg EBV-TCR-T cells per dose",[13],"Biological: EBV-TCR-T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","EBV-TCR-T cells","The patients with EBV-HLH or EBV infection will receive infusions of EBV-TCR-T cells, with the escalated dose ranging from 1×10\\^6\u002Fkg to 1×10\\^8\u002Fkg EBV-TCR-T cells per dose.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Daihong Liu, Doctor","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+86 18301339032","daihongrm@163.com",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Liping Dou, Doctor","+8613681207138","lipingruirui@163.com",[35],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Beijing","Beijing Municipality","100853","China","CN",{"type":43,"coordinates":44},"Point",[45,46],116.39723,39.9075,{"lat":46,"lon":45},[49,50],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},{"type":24,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Daihong Liu","Director","100526529","phase-1-clinical-study-of-ebv-tcr-t-cells-for-ebv-associated-hemophagocytic-lymphohistiocytosis-or-ebv-infection-100526529",false,"NCT06135922","Clinical Study of EBV-TCR-T Cells for EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection","Multicenter, Open Label, Single-arm Exploratory Clinical Study of EBV-TCR-T Cells for EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection","Inclusion Criteria:\n\n* Age 1-60 years, gender unlimited.\n* Diagnosed with EBV associated-hemophagocytic lymphohistiocytosis (HLH) or EBV infection.\n* Fully understood and informed the study and signed the ICF.\n* Karnofsky Score ≥ 70(age ≥16y) or Lansky Score ≥ 50(age\\\u003C16y).\n* TCRT-T cell donor inclusion criteria: 1)Age \\>=8 years, gender unlimited; 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 or left ventricular ejection fraction\\\u003C50%) one week before TCR-T cell infusion.\n* Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion.\n* Use of immunosuppressive drugs or G-CSF within 2 weeks before PBMC blood collection.\n* Have tumours, active and uncontrolled malignant diseases.\n* Serologically positive for HIV-Ab or TAP-ab.\n* Pregnant or lactating women.\n* Men and their partners or women of childbearing potential refused contraception during the study period.\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 4 weeks of enrollment.\n* Allergy to albumin.\n* TCRT-T cell donor exclusion criteria: 1) pregnant woman; 2) Serologically positive for HBsAg, HCV-Ab, HIV-Ab or TAP-ab; 3) EBV-DNA or CMV-DNA positive; 4) other uncontrolled infection; 5) Use of immunosuppressive drugs or G-CSF within 2 weeks before PBMC blood collection.","ALL","1 Year","60 Years",{"count":65,"type":66},9,"ESTIMATED","INTERVENTIONAL",[69],"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-associated hemophagocytic lymphohistiocytosis (EBV-HLH) or EBV infection",[72,73],"EBV-associated Hemophagocytic Lymphohistiocytosis","EBV Infection","2023-11-12",{"date":76,"type":77},"2023-11-18","ACTUAL",{"date":79,"type":77},"2023-08-01",{"date":81,"type":66},"2026-12-31",{"name":5,"class":6},1]