[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627573":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":51,"collaborators":19,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":19,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":19,"studyType":67,"phases":68,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":35,"whyStopped":19,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EBV-AST Cell Injection","EXPERIMENTAL","Participants with EBV-associated lymphoproliferative disorders (including PTLD and EBV-positive lymphomas) will receive EBV-AST cell injection by intravenous infusion in a dose-escalation scheme. EBV-AST is administered every 2 weeks for up to 3 infusions (Day 0, Day 14, and Day 28). Three dose levels are planned: 3×10\\^5, 3×10\\^6, and 3×10\\^7 cells\u002Fkg per infusion, with dose-escalation decisions based on safety and protocol-defined criteria.",[13],"Biological: EBV-AST Cell Injection",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","EBV-AST is an Epstein-Barr virus (EBV) antigen-specific cytotoxic T-lymphocyte product generated by ex vivo stimulation and expansion of T cells using peptide-loaded dendritic cells. EBV-AST is administered by intravenous infusion every 2 weeks for up to 3 infusions at escalating dose levels (3×10\\^5, 3×10\\^6, or 3×10\\^7 cells\u002Fkg per infusion), according to the protocol-defined dose-escalation design.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Daihong Liu","STUDY_CHAIR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","+8613681171597","daihongrm@163.com",{"name":30,"role":26,"phone":31,"phoneExt":19,"email":32},"Liping Dou","+8613681207138","lipingruirui@163.com",[34],{"facility":5,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Beijing","Beijing Municipality","100853","China","CN",{"type":42,"coordinates":43},"Point",[44,45],116.39723,39.9075,{"lat":45,"lon":44},[48,50],{"name":22,"role":26,"phone":49,"phoneExt":19,"email":28},"+8618301339032",{"name":19,"role":26,"phone":19,"phoneExt":19,"email":28},{"type":52,"investigatorFullName":22,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","Director, Department of Hematology","100627573","phase-1-ebv-ast-cell-injection-for-ebv-associated-lymphoproliferative-disorders-100627573",false,"NCT07450391","EBV-AST Cell Injection for EBV-Associated Lymphoproliferative Disorders","Exploratory Clinical Study of EBV-AST Cell Injection for the Treatment of EBV-Associated Lymphoproliferative Disorders","Inclusion Criteria:\n\n1. Able to understand and voluntarily sign written informed consent.\n2. Age 18 to 75 years, inclusive.\n3. HLA genotype matches at least one of the following: HLA-A02:01, HLA-A11:01, or HLA-A\\*24:02.\n4. Karnofsky Performance Status (KPS) ≥ 70.\n5. Life expectancy ≥ 3 months.\n6. Diagnosed with EBV-associated lymphoproliferative disorders, including:\n7. EBV infection-associated post-transplant lymphoproliferative disorder (PTLD) that is relapsed\u002Frefractory after at least first-line standard therapy; or\n8. EBV-associated lymphoma confirmed by histology and\u002For cytology with EBER positivity (ISH\u002FFISH), with no standard treatment available or not suitable for standard therapy, including but not limited to: EBV-positive DLBCL, EBV-positive NK\u002FT-cell lymphoma, EBV-positive Hodgkin lymphoma, EBV-positive Burkitt lymphoma, EBV-positive nodal TFH lymphoma (AITL type), and EBV-positive primary cutaneous T-cell lymphoma, meeting protocol-defined relapsed\u002Frefractory criteria.\n9. Absolute lymphocyte count ≥ 0.8 × 10\\^9\u002FL (except for PTLD participants).\n10. Adequate organ and bone marrow function per protocol-defined criteria.\n11. Participants of childbearing potential agree to use highly effective contraception throughout the study; women of childbearing potential must have a negative pregnancy test at screening.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to the investigational product or its components.\n2. Uncontrolled active graft-versus-host disease (GVHD) in PTLD participants.\n3. Known primary immunodeficiency disorders (e.g., X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, chronic granulomatous disease, hyper-IgE syndrome).\n4. Severe uncontrolled medical conditions that, in the investigator's judgment, make the participant unsuitable for enrollment.\n5. Serious cardiac disease within 6 months prior to first infusion (e.g., myocardial infarction, severe\u002Funstable angina, bypass surgery, NYHA class III-IV heart failure).\n6. Chronic diseases requiring systemic immunosuppressants or systemic steroids (except local\u002Finhaled steroids or physiologic replacement therapy).\n7. History of other malignancy within the past 5 years, except carcinoma in situ (e.g., cervix, bladder, breast) or non-melanoma skin cancer.\n8. Receipt of lymphocyte-based immunotherapy (e.g., CIK, DC, DC-CIK, LAK) within 3 months prior to consent.\n9. Receipt of interferon or other targeted immunodeficiency drugs within 3 months prior to consent; prior high-dose IL-2 therapy.\n10. Anti-cancer therapy within 14 days prior to consent (including chemotherapy or immunosuppressants\u002Fsteroids); other cell therapy or live vaccines\u002Fattenuated vaccines or other investigational drugs within 28 days prior to consent; curative radiotherapy or major surgery within 4 weeks, or palliative local radiotherapy within 2 weeks prior to consent.\n11. Prior immune therapy-associated ≥ Grade 3 immune-related adverse events (irAEs).\n12. Unresolved toxicity from prior therapy \\> Grade 1 (except alopecia any grade; peripheral sensory neuropathy ≤ Grade 2).\n13. Uncontrolled psychiatric or neurologic disorders; drug abuse or alcohol dependence.\n14. Positive HIV antibody; positive Treponema pallidum antibody; active hepatitis B (HBsAg and\u002For HBeAg positive with HBV-DNA above ULN) or active hepatitis C (HCV-Ab positive and HCV-RNA positive).\n15. Uncontrolled severe active infection or contagious disease (excluding EBV infection).\n16. Pregnant or breastfeeding women.","ALL","18 Years","70 Years",{"count":65,"type":66},18,"ESTIMATED","INTERVENTIONAL",[69,70],"PHASE1","PHASE2","This is an investigator-initiated, open-label, single-arm, dose-escalation exploratory study to evaluate the safety, tolerability, and preliminary efficacy of EBV-AST cell injection in adults with EBV-associated lymphoproliferative disorders, including post-transplant lymphoproliferative disease (PTLD) and EBV-positive lymphomas. Participants will receive EBV-AST cell infusions intravenously every 2 weeks for up to 3 infusions at escalating dose levels. The primary objective is to assess safety and determine a potential optimal biologically active dose. Secondary objectives include preliminary tumor response and EBV-related virologic outcomes, as well as cellular PK\u002FPD.",[73,74],"Epstein-Barr Virus-Associated Lymphoproliferative Disorders","EBV-Positive Lymphoma",[76,77,78,79],"EBV-associated lymphoproliferative disorder","EBV-positive lymphoma","Adoptive T-cell therapy","Antigen-specific T cells","2026-02-26",{"date":82,"type":83},"2026-03-04","ACTUAL",{"date":85,"type":83},"2025-06-01",{"date":87,"type":66},"2027-06-01",{"name":22,"class":6},1]