[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-transplant-lymphoproliferative-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-transplant-lymphoproliferative-disorder":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,71,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100573038","phase-1-bzlf1-peptide-vaccine-osu-2131-with-qs-21-for-the-prevention-of-epstein-barr-virus-related-cancer-in-patients-awaiting-solid-organ-transplants-100573038",false,"NCT06741072","BZLF1 Peptide Vaccine (OSU-2131) With QS-21 for the Prevention of Epstein-Barr Virus Related Cancer in Patients Awaiting Solid Organ Transplants","A Phase 1B Double Blinded Randomized Trial Evaluating Safety, Tolerability, and Immune Response of OSU-2131 a BZLF1 Peptide Vaccine With Stimulon™ QS-21 Solution Adjuvant in Healthy Volunteers and Patients Awaiting Solid Organ Transplantation","Inclusion Criteria:\n\n* Healthy volunteers and patients awaiting solid organ transplantation (SOT) must have at least one allele for HLA-B\\*08:01\n* Subjects can be Epstein-Barr virus (EBV) seronegative or seropositive\n* Subjects must be seronegative for HIV\n* Subjects must be seronegative for hepatitis B and C\n* Have baseline chemistry and hematology (hemoglobin, white blood cells, absolute neutrophil count, eosinophils) within normal limits\n* Prothrombin time (PT) and partial thromboplastin time (PTT) below the upper limit of normal\n* Platelets above the lower limit of normal (LLN)\n* Basophils, lymphocytes, and monocytes must be within 1.2 x upper limit of normal (ULN) or 0.8 x LLN and considered not clinically significant by the investigator\n* Total creatine kinase (CK) laboratory values \\\u003C 1.25 x the upper limit of normal (according to the normal reference ranges of the Ohio State University \\[OSU\\] laboratory) at baseline (screening \\& pre-study visit) and considered not clinically significant by the investigator\n* Subjects must not be taking antiviral therapy\n* Must be ≥ 18 years of age and ≤ 65 years of age and willing to either use an effective method of contraception or abstain from sexual activity for at least 3 months following the last dose of vaccination\n* Female of childbearing potential must have a negative serum pregnancy test prior to the first study drug\u002Fplacebo (PBS) administration\n* Agree not to receive any other investigational drug while enrolled in this study\n* Provide written informed consent according to International Conference on Harmonization-Good Clinical Practice (ICH-GCP) and local regulations\n* Following successful completion of safety evaluation for the phase 1 dose escalation phase of this trial in healthy volunteers and review of this data by the Sponsor and Food and Drug Administration (FDA), we plan to enroll a second cohort of patients awaiting solid organ transplantation (SOT). We will recruit patients with end stage renal disease (ESRD) who are awaiting kidney transplantation. ESRD is defined according to 2012 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease (Acosta-Ochoa et al, J Clin Med, 8(9):1323, 2019). KDIGO defines ESRD as: stage 4: severe reduction in glomerular filtration rate (GFR) (15 to 29 mL\u002Fmin); stage 5: renal failure (GFR less than 15 mL\u002Fmin). Patients will qualify for ESRD \u002F kidney transplantation per need for maintenance dialysis due to one or more of the criteria related to renal insufficiency: volume overload, metabolic acidosis, electrolyte disturbance, drug toxicity, etc. Patients will be regularly undergoing hemodialysis or peritoneal dialysis for metabolic support. Patients will be excluded from the study if they have any unstable medical conditions which the investigator believes would preclude participation in the study. These conditions include but are not limited to cardiorenal and hepatorenal syndromes\n\nExclusion Criteria:\n\n* Severe active infection, compromised cardiopulmonary function, or other serious medical illness that, in the opinion of the principal investigator, would prevent study completion\n* History of chronic active EBV infection, active infectious mononucleosis (or infectious mononucleosis within 6 months of enrollment), or other EBV-related disorder as determined by principal investigator (PI)\n* History of immune suppression or autoimmune disorder\n* Concomitant use of systemic corticosteroids or other immunosuppressive medications (including nasal and inhaled steroids). The use of nasal steroids for seasonal rhinitis is acceptable\n* Pregnant or breastfeeding subjects\n* For patient enrollment on the second cohort, \"patients awaiting SOT\", we will consider patients awaiting kidney transplantation who are receiving maintenance renal replacement therapy (dialysis). Most patients on routine renal replacement therapy (dialysis) will present with stable chemistry, acid base balance, volume status and clear mental status. For patients who are non-compliant with routine dialysis, laboratory abnormalities and acid base, volume status can become abnormal. Specific dose limiting toxicity (DLT) criteria that may relate to patients with ESRD include laboratory parameters that may altered due to missed dialysis session(s). Most laboratory abnormalities in such patients can be corrected by restarting dialysis or blood transfusions. Outside these specific variables, we do not expect to see specific DLT criteria for patients with ESRD on this study. Metabolic derangement such as acid base imbalance, hyperkalemia and volume overload as a result of missing dialysis session. Study stopping rule for subjects awaiting organ transplant: Occurrence of this event in two or more subjects should result in study pause. Patients who are unable to adhere to routine dialysis will be excluded from the study if they have any unstable medical conditions which the investigator believes would preclude participation in the study. These conditions include but are not limited to cardiorenal and hepatorenal syndromes",true,"ALL","18 Years","65 Years",{"count":21,"type":22},55,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This phase 1B trial tests the safety, side effects and best dose of rh-Hsc70- BZLF1 peptide complex (OSU-2131) with Stimulon (Trademark) QS-21 and evaluates how well it works in preventing Epstein-Barr virus (EBV) infection and related cancers in healthy volunteers and patients awaiting a solid organ transplant. Currently, patients who receive an organ transplant receive immune suppression therapy which can make it harder for the body to fight infections. This treatment also increases the risk for cancers that are triggered by the EBV. Vaccines made from synthetic peptide (RAKFKQLL) derived from the BZLF1 protein, may help the body build an effective immune response against EBV infections. QS-21, a saponin adjuvant, is a substance from plants that, when given with vaccine therapy, may improve the way the immune system responds to disease. Giving OSU-2131 with QS-21 may help the immune system fight EBV and protect against EBV infection and the cancers that it can cause in patients awaiting solid organ transplants.",[28,29,30,31,32],"Chronic Kidney Disease, Stage 4","Chronic Kidney Disease, Stage 5","EBV-Related Lymphoproliferative Disorder","EBV-Related Malignant Neoplasm","Post-Transplant Lymphoproliferative Disorder","RECRUITING","2026-06-30",{"date":36,"type":37},"2026-07-02","ACTUAL",{"date":39,"type":37},"2026-06-28",{"date":41,"type":22},"2027-12-31",{"name":43,"class":44},"Ohio State University Comprehensive Cancer Center","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":45},"100637034","phase-1-loncastuximab-tesirine-and-rituximab-as-first-line-therapy-in-patients-with-post-transplant-lymphoproliferative-disorder-pluto-100637034","NCT07573436","Loncastuximab Tesirine and Rituximab as First-line Therapy in Patients With Post-transplant Lymphoproliferative Disorder (PLUTO)","A Phase 1\u002F2 Study of Loncastuximab Tesirine and Rituximab as First-line Therapy in Patients With Post-transplant Lymphoproliferative Disorder (PLUTO)","PLUTO","Inclusion Criteria:\n\n* Subject aged ≥ 18 years.\n* Histologically confirmed B-cell PTLD (monomorphic and polymorphic) following solid organ transplantation; with or without EBV association.\n\n  --Note: Subjects with classic Hodgkin-like PTLD are excluded.\n* Measurable disease as defined by the 2014 Lugano Classification as assessed by positron-emission tomography (PET)- computed tomography (CT) or by CT or magnetic resonance imaging (MRI) if the tumor is not fluorodeoxyglucose (FDG)-avid on screening\n* ECOG Performance Status ≤ 2.\n* Adequate organ function as defined as:\n\n  * Hematologic:\n\n    * Absolute neutrophil count (ANC) ≥ 1000\u002Fmm3\n    * Platelet count ≥ 75,000\u002Fmm3\n    * Hemoglobin ≥ 8 g\u002FdL\n  * Hepatic:\n\n    * Bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN with document liver involvement and\u002F or Gilbert's disease\n    * Transaminases (AST or ALT) ≤ 3 x ULN or ≤ 5 x ULN with documented liver involvement\n  * Renal:\n\n    * Estimated creatinine clearance ≥ 60 mL\u002Fmin by Cockcroft-Gault formula.\n* For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * Women \\\u003C 50 years of age:\n\n    * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or\n    * Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n  * Women ≥ 50 years of age:\n\n    * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n    * Had radiation-induced menopause with last menses \\>1 year ago; or\n    * Had chemotherapy-induced menopause with last menses \\>1 year ago; or\n    * Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n* Female subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception and the lactation requirements as described in Sections 5.4.1 and 5.4.2.\n* Subjects or their legal representatives must be able to read, understand, and provide informed consent to participate in the trial.\n* Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol\n\nExclusion Criteria:\n\n* PTLD following liquid transplantation\n* CNS involvement\n* Prior treatment for PTLD with the exception of radiation, antivirals, steroids and reduced immunosuppression\n* Human immunodeficiency virus (HIV) infection\n* Major surgery within 4 weeks prior to enrolment\n* History of bleeding diathesis (e.g., von Willebrand's disease), hemophilia, or active bleeding.\n* Subjects with chronic liver disease with hepatic impairment Child-Pugh class C\n* Pregnant or lactating or intending to become pregnant during the study\n* Active autoimmune disease which, in the opinion of the investigator, may negatively impact subject safety or interfere with study participation.\n* The diagnosis of another malignancy which, in the opinion of the investigator, is likely to negatively impact subject safety or interfere with study participation.\n* Significant medical diseases or conditions including those requiring substantial changes in concomitant medications, as assessed by the investigator, that would substantially increase the risk-to-benefit ratio of participating in the study. This includes, but is not limited to the following conditions:\n\n  * Cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.\n    * Myocardial infarction (MI) within 6 months before the first dose.\n    * QTc prolongation defined as a QTcF \\> 480 ms.\n    * Congenital long QT syndrome or a corrected QT measure (QTc) interval of \\>480 ms at screening (unless secondary to pacemaker or bundle branch block).\n    * Grade 2 or higher edema (peripheral, pleural or ascites)\n    * Grade 1 or higher pericardial effusion\n  * Severe pulmonary disease\n  * Uncontrolled diabetes mellitus\n  * Severely immunocompromised state\n  * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.\n* Active systemic bacterial, viral, fungal, or other infection requiring systemic treatment at time of screening\n* Subjects with evidence of active hepatitis B infection, based on positive surface antigen or Hepatitis B DNA PCR are excluded. Subjects who are Hepatitis B core antibody positive must take prophylaxis with entecavir or equivalent and be willing to undergo monthly Hepatitis B DNA PCR testing\n* Active hepatitis C infection\n* Grade 2 or higher rash\n* Clinically significant fluid accumulation in the third space\n* Subjects taking prohibited medications as described in Section 6.8.1. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.",{"count":55,"type":22},23,[25,57],"PHASE2","The purpose of phase I of this clinical trial is to learn the recommended dose of the drugs loncastuximab tesirine and rituximab in participants with post-transplant lymphoproliferative disorders (PTLD).\n\nThe purpose of phase II of this clinical trial is to learn if the drugs loncastuximab tesirine and rituximab are effective in participants with post-transplant lymphoproliferative disorders (PTLD).",[60],"Post-transplant Lymphoproliferative Disorder","NOT_YET_RECRUITING","2026-04-30",{"date":64,"type":37},"2026-05-07",{"date":66,"type":22},"2026-06",{"date":68,"type":22},"2031-06",{"name":70,"class":44},"University of Utah",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":45},"100626625","phase-1-ebv-ast-cell-therapy-for-ebv-related-diseases-after-stem-cell-transplantation-100626625","NCT07438067","EBV-AST Cell Therapy for EBV-Related Diseases After Stem Cell Transplantation","A Prospective Exploratory Study of EBV-AST Cell Injection for the Treatment of EBV-Related Diseases After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. The patient must be aged 18-75 years.\n2. ust have undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT).\n3. Must have EBV-DNA viremia post-transplant, with EBV-DNA \\> 1000 copies\u002FmL (on two consecutive tests or one test \\> 10,000 copies\u002FmL).\n4. Karnofsky Performance Score (KPS) of 70 or higher.\n5. Expected survival of at least 3 months.\n6. Sufficient organ function, including renal (serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL\u002Fmin), hepatic (AST, ALT, and total bilirubin ≤ 5 × ULN), and hematologic parameters (platelets ≥ 10 × 10\\^9\u002FL, neutrophils ≥ 1.0 × 10\\^9\u002FL).\n7. HLA-matching criteria must be met for the donor\u002Frecipient.\n\nExclusion Criteria:\n\n1. Active GVHD (Grade 2 or higher) or requiring \\>0.5 mg\u002Fkg\u002Fday corticosteroids for GVHD.\n2. History of CMV viremia or disease within the past week.\n3. PTLD (Post-Transplant Lymphoproliferative Disorder) diagnosed or suspected within 1 week before infusion.\n4. Severe active infections (excluding EBV and CMV).\n5. Serious allergic reactions or contraindications to the infusion.\n6. Previous immune therapy-related adverse events of Grade 3 or higher.\n7. History of HIV, HCV, or HBV infection with an active viral load.","75 Years",{"count":80,"type":22},18,[25,57],"This exploratory clinical study focuses on the use of EBV-AST cell infusion for treating EBV-DNA viremia following allogeneic hematopoietic stem cell transplantation (Allo-HSCT). The study aims to determine the maximum tolerated dose (MTD) or optimal biological dose (OBD) of EBV-AST cells and assess their safety, tolerability, and preliminary efficacy in treating EBV-DNA viremia. The study will involve a 3+3 dose escalation design to evaluate three different dosages of EBV-AST cell infusion. The study is expected to provide important insights into the clinical application of cell-based therapies for EBV infections.",[84,32],"EBV-DNA Viremia",[86,87,88],"EBV-DNA viremia","Allogeneic Hematopoietic Stem Cell Transplantation","EBV-AST cell infusion","2026-02-26",{"date":91,"type":37},"2026-02-27",{"date":93,"type":37},"2025-03-26",{"date":95,"type":22},"2028-03-26",{"name":97,"class":44},"Daihong Liu",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":45},"100621285","phase-1-exploratory-study-of-ebv-tcr-t-cell-injection-for-ebv-dnaemia-after-allogeneic-hematopoietic-stem-cell-transplantation-100621285","NCT07368634","Exploratory Study of EBV-TCR-T Cell Injection for EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation","An Exploratory Clinical Study of EBV-TCR-T Cell Injection for the Treatment of EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of enrollment.\n* History of allogeneic hematopoietic stem cell transplantation.\n* Presence of Epstein-Barr virus (EBV) DNAemia confirmed by quantitative polymerase chain reaction (qPCR) in peripheral blood.\n* EBV DNAemia persisting or increasing despite standard management, as determined by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Adequate organ function as defined by the study protocol.\n* Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of EBV-associated lymphoproliferative disorder requiring immediate cytotoxic chemotherapy.\n* Active, uncontrolled infection other than EBV.\n* History of severe autoimmune disease requiring systemic immunosuppressive therapy.\n* Uncontrolled graft-versus-host disease requiring high-dose systemic corticosteroids or other immunosuppressive treatment.\n* Prior treatment with EBV-specific adoptive T cell therapy within a defined washout period.\n* Known active malignancy other than EBV-related disease that may interfere with study participation.\n* Pregnant or breastfeeding women.\n* Any medical, psychological, or social condition that, in the opinion of the investigator, would interfere with safe participation in the study.","70 Years",{"count":80,"type":22},[25,57],"Epstein-Barr virus (EBV) DNAemia is a common and potentially serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT) and may progress to EBV-associated lymphoproliferative disorders. Current treatment options are limited, and effective immune-based therapies are still needed.\n\nThis is an investigator-initiated, exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of EBV-specific T cell receptor-engineered T cells (EBV-TCR-T cell injection) in patients with EBV DNAemia after allo-HSCT. Eligible participants will receive intravenous infusions of EBV-TCR-T cells at escalating dose levels. Safety outcomes, EBV-DNA clearance, and preliminary efficacy will be assessed, along with pharmacokinetic and pharmacodynamic characteristics of the infused cells.",[110,32],"Epstein-Barr Virus Infection",[112,113,114],"EBV DNAemia","TCR-T Cell Therapy","Dose Escalation Study","2026-01-26",{"date":117,"type":37},"2026-01-28",{"date":119,"type":37},"2025-06-01",{"date":121,"type":22},"2027-06-01",{"name":97,"class":44}]