[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627573":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":62,"studyPopulation":55,"armGroups":63,"interventions":70,"overallOfficials":75,"centralContacts":79,"locations":88,"responsibleParty":106,"collaborators":55,"id":109,"slug":55,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":55,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":55,"studyType":121,"phases":122,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":90,"whyStopped":55,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":55},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Dose-Limiting Toxicities (DLTs)","Number of participants experiencing dose-limiting toxicities (DLTs) within 28 days after the first EBV-AST cell infusion, as defined by protocol-specific criteria and graded according to NCI CTCAE v5.0.","From first infusion (Day 0) through Day 28",{"measure":14,"description":15,"timeFrame":16},"Safety: Incidence of Adverse Events","Number of participants with treatment-emergent adverse events (AEs), immune-related adverse events (irAEs), and serious adverse events (SAEs), graded according to NCI CTCAE v5.0, including clinically significant laboratory abnormalities.","From first infusion (Day 0) through 12 months after first infusion",{"measure":18,"description":19,"timeFrame":20},"Recommended\u002FOptimal Biologically Active Dose (OBD)","Recommended\u002Foptimal biologically active dose (OBD) of EBV-AST, determined based on the incidence of DLTs, overall safety profile, and tolerability across dose levels.","Up to 28 days after first infusion for DLT evaluation; overall dose decision through study completion",[22,25,28,31,34,38,41,44,48,51],{"measure":23,"description":24,"timeFrame":16},"Objective Response Rate (ORR)","Objective response rate (ORR), defined as the proportion of participants achieving complete response (CR) or partial response (PR) according to protocol-defined response criteria.",{"measure":26,"description":27,"timeFrame":16},"Disease Control Rate (DCR)","Disease control rate (DCR), defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) according to protocol-defined criteria.",{"measure":29,"description":30,"timeFrame":16},"Progression-Free Survival (PFS)","Progression-free survival (PFS), defined as the time from first EBV-AST infusion to documented disease progression or death from any cause.",{"measure":32,"description":33,"timeFrame":16},"Overall Survival (OS)","Overall survival (OS), defined as the time from first EBV-AST infusion to death from any cause.",{"measure":35,"description":36,"timeFrame":37},"Duration of Response (DOR)","Duration of response (DOR), defined as the time from first documented complete or partial response to disease progression or death.","From first documented response through 12 months after first infusion",{"measure":39,"description":40,"timeFrame":16},"EBV-DNA Negativity Rate","Proportion of participants achieving EBV-DNA negativity in peripheral blood as measured by quantitative polymerase chain reaction (qPCR).",{"measure":42,"description":43,"timeFrame":16},"Time to EBV-DNA Negativity","Time from first EBV-AST infusion to first documented EBV-DNA negativity in peripheral blood.",{"measure":45,"description":46,"timeFrame":47},"Change in EBV-DNA Level","Change from baseline in EBV-DNA levels in peripheral blood over time, as measured by quantitative polymerase chain reaction (qPCR).","From baseline through 12 months after first infusion",{"measure":49,"description":50,"timeFrame":12},"Maximum Concentration (Cmax) of EBV-AST Cells in Peripheral Blood","The highest measured absolute concentration of viable EBV-AST cells in peripheral blood following infusion, quantified by flow cytometry.",{"measure":52,"description":53,"timeFrame":54},"Concentration of EBV-AST Cells in Peripheral Blood (Cmax)","Maximum absolute concentration of viable EBV-AST cells in peripheral blood post-infusion, quantified by flow cytometry. Unit of Measure: viable EBV-AST cells per microliter (cells\u002FμL).","From baseline through Day 28 after first infusion",null,{"allocation":57,"interventionModel":58,"interventionModelDescription":55,"primaryPurpose":59,"observationalModel":55,"timePerspective":55,"maskingInfo":60},"NA","SINGLE_GROUP","TREATMENT",{"masking":61,"maskingDescription":55,"whoMasked":55},"NONE","EBV-associated lymphoproliferative disorders (LPD), including PTLD and EBV-positive lymphomas, are clinically challenging and may occur in immunocompromised or heavily treated patients. EBV-AST is a cellular immunotherapy consisting of EBV antigen-specific cytotoxic T lymphocytes generated by ex vivo stimulation and expansion of T cells using antigen peptide-loaded dendritic cells. After infusion, EBV-AST cells are expected to recognize and eliminate EBV-infected or EBV-antigen-expressing target cells and provide EBV-specific immune reconstitution.\n\nThis investigator-initiated, open-label, single-arm exploratory study uses a dose-escalation design to evaluate EBV-AST cell injection in adults with EBV-associated LPD. Approximately 4-18 participants will be enrolled across three dose levels (3×10\\^5, 3×10\\^6, and 3×10\\^7 cells\u002Fkg per infusion). EBV-AST will be administered by intravenous infusion every 2 weeks for up to three infusions, following protocol-defined escalation rules and DLT assessment within 28 days after the first infusion. Participants will be monitored for adverse events and immune-related toxicities, and assessed for preliminary efficacy (tumor response and EBV-DNA\u002Fvirologic outcomes) and cellular PK\u002FPD.",[64],{"label":65,"type":66,"description":67,"interventionNames":68},"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.",[69],"Biological: EBV-AST Cell Injection",[71],{"type":72,"name":65,"description":73,"armGroupLabels":74,"otherNames":55},"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.",[65],[76],{"name":77,"affiliation":5,"role":78},"Daihong Liu","STUDY_CHAIR",[80,84],{"name":77,"role":81,"phone":82,"phoneExt":55,"email":83},"CONTACT","+8613681171597","daihongrm@163.com",{"name":85,"role":81,"phone":86,"phoneExt":55,"email":87},"Liping Dou","+8613681207138","lipingruirui@163.com",[89],{"facility":5,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"RECRUITING","Beijing","Beijing Municipality","100853","China","CN",{"type":97,"coordinates":98},"Point",[99,100],116.39723,39.9075,{"lat":100,"lon":99},[103,105],{"name":77,"role":81,"phone":104,"phoneExt":55,"email":83},"+8618301339032",{"name":55,"role":81,"phone":55,"phoneExt":55,"email":83},{"type":107,"investigatorFullName":77,"investigatorTitle":108,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"SPONSOR_INVESTIGATOR","Director, Department of Hematology","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":119,"type":120},18,"ESTIMATED","INTERVENTIONAL",[123,124],"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.",[127,128],"Epstein-Barr Virus-Associated Lymphoproliferative Disorders","EBV-Positive Lymphoma",[130,131,132,133],"EBV-associated lymphoproliferative disorder","EBV-positive lymphoma","Adoptive T-cell therapy","Antigen-specific T cells","2026-02-26",{"date":136,"type":137},"2026-03-04","ACTUAL",{"date":139,"type":137},"2025-06-01",{"date":141,"type":120},"2027-06-01",{"name":77,"class":6},1]