[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ebv-related-lymphoproliferative-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ebv-related-lymphoproliferative-disorder":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":4,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100413483","phase-1-ebv-specific-t-lymphocytes-for-treatment-of-ebv-positive-lymphoma-100413483","NCT04664179","EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma","Constitutive IL7 (C7R) Modified EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma","CILESTE","1. INCLUSION CRITERIA AT TIME OF PROCUREMENT\n\n   1. Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non Hodgkin's Lymphoma, (regardless of the histological subtype) or EBV (associated)- T\u002FNK-lymphoproliferative disease who may subsequently be eligible for the treatment component\n   2. EBV positive tumor (can be pending)\n   3. Weighs at least 10 kg\n   4. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given a copy of informed consent.\n2. INCLUSION CRITERIA AT TIME OF INFUSION\n\n   1\\) Any patient regardless of age or sex, with diagnosis of either\n   1. EBV positive Hodgkin's lymphoma\n   2. EBV positive non-Hodgkin's Lymphoma (regardless of histologic subtype)\n   3. EBV (associated)-T\u002FNK-lymphoproliferative disease\n\n   AND either\n\n   A) In first or subsequent relapse or with persistent active disease despite therapy; OR\n\n   B) With active disease if immunosuppressive chemotherapy is contraindicated as determined by the study PI, in consultation with the primary provider as needed, e.g. patients who develop Hodgkin's disease after solid organ transplantation or if the lymphoma is a second malignancy, e.g. a Richter's transformation of CLL.\n\n   2\\) EBV positive tumor confirmed by pathology\n\n   3\\) Patients with life expectancy ≥ 6 weeks\n\n   4\\) Patients with bilirubin ≤ 3x upper limit of normal, AST ≤ 3x upper limit of normal, creatinine ≤ 2x upper limit of normal for age and Hgb ≥ 7.0 (may be a transfused value)\n\n   5\\) Pulse oximetry of \\>90% on room air\n\n   6\\) Patients should have been off other investigational therapy for 4 weeks prior to entry in this study.\n\n   7\\) Patients with a Karnofsky\u002FLansky score of ≥ 50\n\n   8\\) Informed consent explained to, understood and signed by patient\u002Fguardian. Patient\u002Fguardian given a copy of informed consent.\n3. EXCLUSION CRITERIA AT TIME OF PROCUREMENT\n\n   1\\. Known pregnancy or actively breastfeeding (pregnancy test is not required at the time of procurement).\n4. EXCLUSION CRITERIA AT TIME OF INFUSION\n\n   1. Pregnant or breastfeeding\n   2. Active and uncontrolled bacterial, viral or fungal infection\n   3. Current use of systemic corticosteroids (prednisone equivalent \\>0.5 mg\u002Fkg\u002Fday)\n   4. Bulky disease resulting in airway obstruction or risk for airway obstruction with further enlargement.",{"count":55,"type":22},52,[25],"This study is for patients that have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T\u002FNK-lymphoproliferative disease which has come back or has not gone away after treatment, including the best treatment the investigators know for these diseases.\n\nSome patients with Lymphoma or T\u002FNK-lymphoproliferative disease show signs of virus that is sometimes called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever (\"mono\") before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's and non-Hodgkin Lymphoma, suggesting that plays a role in causing Lymphoma. The cancer cells (in lymphoma) and some immune system cells infected by EBV are able to hide from the body's immune system and escape destruction.\n\nT cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. T cells have been used to treat patients with cancers. T cells, that have been trained to kill EBV infected cells can survive in the blood and affect the tumor. The investigators have treated over 80 people on studies using T cells to target these diseases. About half of those patients who had disease at the time they got the cells had responses including some patients with complete responses.\n\nThe investigators think that if T cells are able to last longer in the body, they may have a better chance of killing EBV and EBV infected tumor cells. Therefore, in this study the investigators will add a new gene to the EBV T cells that can cause the cells to live longer called C7R. The investigators know that T cells need substances called cytokines to survive and the cells may not get enough cytokines after infusion into the body. The investigators have added the gene C7R that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time.\n\nThe purpose of this study is to find the largest safe dose of C7R-EBV T cells, and additionally to evaluate how long they can be detected in the blood and what affect they have on cancer.",[59,30,60],"EBV-Related Hodgkin Lymphoma","EBV Related Non-Hodgkin's Lymphoma",[62,63,64,65,66,67],"non-Hodgkin's Lymphoma","EBV (associated)-T\u002FNK-lymphoproliferative disease","EBV SPECIFIC T-LYMPHOCYTES","EBV","Hodgkin's Lymphoma","lymphoma relapse","2026-06-22",{"date":70,"type":37},"2026-06-25",{"date":72,"type":37},"2022-10-31",{"date":74,"type":22},"2042-11",{"name":76,"class":44},"Baylor College of Medicine",4]