[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ebv-associated-hemophagocytic-lymphohistiocytosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ebv-associated-hemophagocytic-lymphohistiocytosis":27},{"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":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"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":20,"type":21},9,"ESTIMATED","INTERVENTIONAL",[24],"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",[27,28],"EBV-associated Hemophagocytic Lymphohistiocytosis","EBV Infection","RECRUITING","2023-11-12",{"date":32,"type":33},"2023-11-18","ACTUAL",{"date":35,"type":33},"2023-08-01",{"date":37,"type":21},"2026-12-31",{"name":39,"class":40},"Chinese PLA General Hospital","OTHER"]