[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bk-virus-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bk-virus-infection":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,43,73,100,135,163,187,220,239,259],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100557503","immune-registry-for-bk-in-kidney-transplant-recipients-100557503",false,"NCT06538961","Immune Registry for BK in Kidney Transplant Recipients","Immune Registry for BK (Polyomavirus Hominis 1) in Kidney Transplant Recipients","Inclusion Criteria:\n\n* Adult (\\>18 years old) male and female, deceased donor KT recipients\n* Will include single organ transplants.\n* Each participant must also have recently been diagnosed with BK viremia.\n* In addition to the aforementioned inclusion criteria, each participant in the sub-study must also have recently been diagnosed with BK viremia or have difficult-to-treat BKV \\> 3 logs (BKV log does not decrease by more than 1 log copy\u002Fml drop on second per protocol lab).\n\nExclusion Criteria:\n\n* Prisoners will not be included in the study\n* Multi-organ transplants and pregnant women","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","24 Months","OBSERVATIONAL","Kidney transplantation (KT) is the best treatment modality available to date for patients with advanced kidney disease and the success of KT is dependent on maintaining a selective intricate balance between the risk of rejection and infections in KT recipients. BK virus is an important clinical infection affecting the post-transplant outcomes in KT recipients. BK nephropathy can affect 8-15% of patients after KT causing acute kidney injury, increased risk of rejection and fibrosis leading to additional hospital stays, increasing overall health care cost burden, and in some cases graft loss. The exact pathogenesis and treatment options for BK nephropathy are not clearly understood. It is debatable whether BK nephropathy is a full fledge donor-derived infection or reactivation of the recipient's latent infection. Irrespective of etiology, the common consensus is that treatment of BK virus infection depends on the selective restoration of host immune responses and balancing the risk of rejection vs worsening of infection.",[25,26],"BK Virus Infection","Kidney Transplant; Complications",[28,29],"Immune Registry","BK in Kidney Transplant Recipients","RECRUITING","2026-06-25",{"date":33,"type":34},"2026-06-26","ACTUAL",{"date":36,"type":34},"2024-05-29",{"date":38,"type":20},"2026-07",{"name":40,"class":41},"Virginia Commonwealth University","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":42},"100245918","phase-2-cytotoxic-t-lymphocytes-in-treating-patients-with-malignancies-with-bk-andor-jc-virus-100245918","NCT02479698","Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and\u002For JC Virus","Phase II Study Assessing the Effect of BK Specific CTL Lines Generated by Ex Vivo Expansion in Patients With BK Virus Infection and JC Virus Infection","Inclusion Criteria:\n\n* Patients ≥ 2 years. English and non-English speaking patients are eligible.\n* Immunocompromised patients; and\u002For Non-immunocompromised patients with PML\u002FJC virus Encephalitis; and\u002For patients with any type of malignancies; and\u002For HIV\u002FAIDs; and\u002For history of solid organ transplant; and\u002For Merkel polyoma-virus related Merkel cell tumor(s) with measurable disease on imaging per RECIST criteria.\n* Patients with microscopic hematuria OR biopsy proven BK nephritis and urine or blood PCR positive for BK virus and\u002For JC viral encephalitis and\u002For JC end-organ disease and\u002For polyomavirus.\n* Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg\u002Fkg\u002Fday of prednisone.\n* Patients who are currently receiving treatment with cidofovir, leflunomide, or other antiviral therapy with no response, will be eligible for CTL infusion.\n* Written informed consent and\u002For signed assent from patient, parent or guardian. Patients with cognitive impairments are eligible.\n* Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.\n* Patients enrolled on this study may be enrolled on other IND studies at the discretion of the PI.\n* Patients may be re-enrolled in the protocol should the infection re-occur, provided they meet all the other eligibility criteria at the moment of re-enrollment.\n\nExclusion Criteria:\n\n* Patients receiving prednisone \\> 0.5 mg\u002Fkg\u002Fday at time of enrollment, or have received ATG within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment.\n* Patients with other uncontrolled infections (except HIV\u002FAIDS). For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection\n* Patients with active acute (GVHD) grades II-IV",{"count":51,"type":20},100,"INTERVENTIONAL",[54],"PHASE2","This phase II trial studies how well donor cytotoxic T lymphocytes work in treating patients with malignancies with BK and\u002For JC virus. Cytotoxic T lymphocytes are made from donated blood cells that are grown in the laboratory and are designed to kill viruses that can cause infections in transplant patients and may be an effective treatment in patients with malignancies with BK and\u002For JC virus.",[57,25,58,59,60,61,62,63],"Acquired Immunodeficiency Syndrome","Human Immunodeficiency Virus","JC Virus Infection","Malignant Neoplasm","Merkel Cell Carcinoma","Merkel Cell Polyomavirus Infection","Viral Encephalitis","2026-06-10",{"date":66,"type":34},"2026-06-12",{"date":68,"type":34},"2015-07-23",{"date":70,"type":20},"2027-07-31",{"name":72,"class":41},"M.D. Anderson Cancer Center",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":52,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":42},"100453357","phase-1-r-mvst-cells-for-treatment-of-viral-infections-100453357","NCT05183490","R-MVST Cells for Treatment of Viral Infections","Phase I Study of Adoptive Immunotherapy of Refractory Viral Infection With ex Vivo Expanded Rapidly Generated Virus Specific T (R-MVST) Cells","Recipient Inclusion Criteria:\n\n* Men and women ages 18 years or older of all ethnic groups will be eligible for the treatment\n* Patients with history of HCT or SOT who demonstrate evidence of viral reactivation and\u002For infection manifesting as end-organ or systemic disease due to one or more of the following viruses: EBV, CMV, ADV or BK virus and suboptimal response to the standard of care therapy.\n* Recurrent or Multiple Viral Infection. RVI defined as occurrence of more than one episode of reactivation that required intervention or symptomatic disease in recipient of allogeneic HCT that required standard of care treatment. MVI defined as more than one virus reactivating (defined by PCR positivity) or causing symptomatic systemic or end-organ disease. At least one of those viral reactivations required standard of care intervention. No standard of care therapy is defined for ADV and BK. Patients with multiple infections\u002Freactivations will be eligible as long as at least one of those viral infections meet the criterium of \"refractory\".\n\nRecipient Exclusion Criteria:\n\n* Patients with other uncontrolled infections, except for CMV, EBV, ADV or BK. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to the day of infusion. For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to R-MVST infusion. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection\n* Patients who receive corticosteroids at ≥ 0.5mg\u002Fkg prednisone or equivalent.\n* Patients who received anti-thymocyte globulin (ATG, Alemtuzumab (Campath), or other T-Cell immunosupressive monoclonal antibodies in the last 28 days.\n* Patients who received methotrexate, or other antimetabolite-type immunosuppressants that are toxic to proliferating T cells in the last 7 days.\n* Patients who received extracorporeal photopheresis within the last 28 days.\n* Patients who received checkpoint inhibitor agents (e.g., nivolumab, pembrolizumab, ipilimumab) within 3 drug half-lives of the most recent dose to the infusion of R-MVST.\n* Received donor lymphocyte infusion in last 28 days.\n* Evidence of GVHD ≥ grade 2\n* Evidence of biopsy-proven acute rejection in SOT recipients\n* Active and uncontrolled relapse of malignancy\n* Patients who are pregnant, or breastfeeding.\n* Female of childbearing potential, or male with a female partner of childbearing potential, unwilling to use a highly effective method of contraception.\n* Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients who have received investigational (IND) product within 14 days of infusion of the the R-MVST cells.\n\nDonor inclusion and exclusion criteria will be followed as per the most current BMT SOP (Donor selection, Donor evaluation and Donor Deferral).",{"count":81,"type":20},36,[83],"PHASE1","The primary objective is to determine the safety and feasibility of administering R-MVST cells to patients with refractory viral reactivation and\u002For symptomatic disease caused by Epstein Barr Virus (EBV), cytomegalovirus (CMV), adenovirus (ADV) or BK virus. R-MVST cells will be generated on-demand from the closest partially human leukocyte antigen (HLA)-matched (minimum haploidentical) healthy donors or from the original allo-transplant donor if available. The investigator will closely monitor the recipients for potential toxicities including graft-versus-host disease (GVHD) post-infusion.\n\nSecondary objectives are to determine the effect of R-MVST infusion on viral load, possible recovery of antiviral immunity post-infusion and for evidence of clinical responses and overall survival. Recipients will be monitored for secondary graft failure at day 28 post R-MVST infusion.",[86,87,88,25],"Epstein-Barr Virus Infections","Cytomegalovirus Infections","Adenovirus",[90,91],"Rapidly generated virus specific T cells (R-MVST)","Refractory viral reactivation","2026-06-08",{"date":64,"type":34},{"date":95,"type":34},"2022-05-03",{"date":97,"type":20},"2028-06",{"name":99,"class":41},"Columbia University",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":108,"conditions":109,"keywords":118,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":42},"100619680","study-of-the-serotype-and-genotype-of-bk-virus-in-kidney-transplant-recipients-and-their-donors-to-identify-individuals-at-risk-of-nephropathy-100619680","NCT07347769","Study of the Serotype and Genotype of BK Virus in Kidney Transplant Recipients and Their Donors to Identify Individuals at Risk of Nephropathy","TYPIK","Inclusion Criteria:\n\n* Kidney transplant patients with a first positive BK virus viral load in urine. - BK virus viral load in urine \\> 3 log copies\u002FmL.\n* More than 3 months post-transplant and less than 2 years post-transplant.\n* Men or women aged 18 years and older.\n* Followed up at Grenoble Alpes University Hospital.\n* Affiliated with social security or beneficiary of such a scheme.\n* Patients who are not opposed to the TYPIK study.\n\nExclusion Criteria:\n\n* Expected renal graft survival is \\\u003C 6 months, estimated by an eGFR \\\u003C 15 mL\u002Fmin\u002F1.73 m² at the time of BKPyV viruria\n* Patients who object to the use of their data and\u002For samples for research purposes\n* Subjects who are excluded from another study\n* Subjects under administrative or judicial supervision",{"count":51,"type":20},"The aim of this observational study is to characterize the urinary replication of BK polyomavirus (BKV) in kidney transplant recipients. Although BKV reactivation after transplantation is well established, the origin of the replicating virus remains uncertain. Current evidence suggests that BKV detected in recipients may originate either from the transplanted kidney (donor-derived) or from viral reactivation in the recipient. The evaluation of new biomarkers to predict BKV replication are needed.\n\nThis study seeks to address the following key questions:\n\n* Origin of the replicating virus: Is the BKV detected in the recipient identical to the virus originating from the donor kidney?\n* Host immune response and viral genotype: Is there an association between the recipient's immune response and the genotype of the replicating BKV?\n* Differences in immune response according to viral replication profile: Does the immune response differ between patients presenting isolated BKV viruria and those with both viruria and viremia?\n* Can new biomarkers help predict BKV replication and viremia?\n\nPatients will be grouped according to their BKV replication profile:\n\nGroup 1: patients with BKV viruria without viremia Group 2: patients with both BKV viruria and viremia Comparisons between these two groups will help identify whether different viral genotypes or immune responses are associated with systemic dissemination (viremia).\n\nKidney transplant recipients will be included if they present BKV viruria during their post-transplant follow-up. Additional blood samples will be collected during scheduled follow-up visits at the university hospital. These visits are part of routine clinical care, and no extra visits will be required specifically for the study.",[110,111,112,113,114,25,115,116,117],"Nephropathy","Opportunistic Viral Infection","Polyoma Virus Nephropathy","BK Nephropathy","BK Viremia; BKV DNAemia","BK Polyomavirus","Immune Response","Neutralizing Antibodies",[119,120,121,122,123,124,125],"TTV","BK polyomavirus","neutralizing antibodies","ELISPOT BKV","genotype","miRNA BKV","urinary chimiokine","2026-05-22",{"date":128,"type":34},"2026-05-27",{"date":130,"type":34},"2026-03-11",{"date":132,"type":20},"2030-09-11",{"name":134,"class":41},"University Hospital, Grenoble",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":52,"phases":144,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":4},"100631659","phase-2-a-study-to-understand-how-a-new-unlicensed-drug-aic468-works-compared-with-a-placebo-against-bk-virus-in-patients-who-have-had-a-kidney-transplant-100631659","NCT07503561","A Study to Understand How a New, Unlicensed Drug (AIC468) Works, Compared With a Placebo, Against BK Virus in Patients Who Have Had a Kidney Transplant.","A Randomized, Adaptive, Double-Blind, Placebo-Controlled, Operationally Seamless Phase 2\u002F3 Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of AIC263029 in the Treatment of BKV Infection in Kidney Transplant Recipients","Inclusion Criteria:\n\n1. Male or female aged 18 years or older\n2. Kidney transplantation within 12 months prior to randomization\n3. First episode of detectable BKV DNA in plasma since last kidney transplantation. As defined by either:\n\n   1. positive BKV DNA test of one time \\>104 IU\u002FmL and \\\u003C106 IU\u002FmL, within 30 days prior to randomization, or\n   2. \\>103 IU\u002FmL and ≤104 IU\u002FmL sustained for at least 2 weeks (confirmed by at least 2 consecutive measurements), with the most recent measurement within 14 days prior to randomization.\n4. Female participants (if of childbearing potential) must agree to remain abstinent (refrain from heterosexual intercourse) or use at least one highly effective contraceptive method that result in a failure rate of \\\u003C1% per year until the end of the trial.\n\n   Male participants must agree to refrain from donating sperm, and to remain abstinent (refrain from heterosexual intercourse) or use a condom with a female partner of childbearing potential until the end of the trial.\n5. Negative serum β-HCG (beta-human chorionic gonadotropin) test for women of child-bearing potential at Screening and a negative urine pregnancy test prior to randomization on Day 1.\n6. Able and willing to provide written informed consent and comply with trial protocol.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any component of the IMP\n2. Estimated glomerular filtration rate (\\[e\\]GFR) \\\u003C30 mL\u002Fminute\u002F1.73 m2 at screening\n3. Alanine transaminase (ALT) \\>2×upper limit of normal (ULN) or direct bilirubin \\>1.1×ULN (except Gilbert's Disease) at screening\n4. Uncontrolled participants who are treated or planned to be treated with an mTOR inhibitor or belatacept as part of their immunosuppression regimen post-transplantation at the time of enrollment and during the trial period\n5. Participants who have received a multi-organ transplant involving a kidney (e.g. kidney-pancreas, kidney-liver, kidney-heart)\n6. Participants who are treated or planned to be treated during trial participation with leflunomide, cidofovir, or medicinal products potentially active against BKV at the time of randomization and during the trial period until end of treatment.\n7. Participants who received antibody-depletion therapy within 3 months prior to randomization, or in the opinion of the Investigator are likely to require antibody-depletion therapy during trial participation. Antibody-depletion therapies include but are not necessarily limited to plasmapheresis, immunoadsorption, and intravenous immunoglobulins (IVIg)\n8. Participants with active kidney transplant rejection or those considered at high-risk of recurrence of native kidney disease (e.g. primary focal segmental glomerulosclerosis \\[FSGS\\], C3 glomerulopathy)\n9. Participants with known donor-specific antibodies (\\[DSA\\], de novo, or pre-transplantation). Kidney transplant recipients with low-level pretransplant DSAs (\\\u003C1,000 mean fluorescence intensity \\[MFI\\]) can be included if no impact on the trial assessments is expected by the discretion of the Investigator.\n10. Pregnant or nursing (lactating) women\n11. Uncontrolled acute or chronic infections such as hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV), cytomegalovirus (CMV), or Epstein-Barr virus (EBV)\n12. History of malignancy within the past 5 years, except completely excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ at least 2 years prior to screening\n13. Documented evidence of the use of another Investigational Medicinal Product (IMP) within 30 days or 5 half-lives of randomization, or until the expected PD effect has returned to baseline (whichever is longer)\n14. Known current alcoholism or drug addiction\n15. Any other condition or laboratory abnormality, that in the opinion of the Investigator, would interfere with the evaluation of the IMP or interpretation of the participant safety data or trial results.",{"count":143,"type":20},24,[54],"The goal of this clinical trial is to learn if AIC263029 is safe and well tolerated in adult kidney transplant recipients with BK virus (BKV) in the blood (viremia). The study will also examine how the body processes AIC263029 and whether it lowers BKV levels in the blood.\n\nResearchers will compare AIC263029 to a placebo (a look-alike injection with no active drug). Participants will be assigned by chance to receive AIC263029 or placebo and will receive weekly injections under the skin for 4 weeks. Participants will have clinic visits and blood tests during treatment and follow-up to monitor safety and measure BKV levels, and will be followed for up to about 24 weeks after treatment.",[25],[148,149,150,151],"BK Virus","BK Viremia in kidney transplant","antisense oligonucleotide","AIC263029","NOT_YET_RECRUITING","2026-05-06",{"date":155,"type":34},"2026-05-08",{"date":157,"type":20},"2026-06-15",{"date":159,"type":20},"2026-12-31",{"name":161,"class":162},"AiCuris Anti-infective Cures AG","INDUSTRY",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":52,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":42},"100447036","phase-1-study-assessing-the-feasibility-safety-and-efficacy-of-genetically-engineered-glucocorticoid-receptor-knock-out-virus-specific-ctl-lines-for-viral-infections-in-immunosuppressed-cancer-patients-100447036","NCT05101213","Study Assessing the Feasibility, Safety and Efficacy of Genetically Engineered Glucocorticoid Receptor Knock Out Virus Specific CTL Lines for Viral Infections in Immunosuppressed Cancer Patients","Inclusion Criteria:\n\n* Patients \\> or = 18 years of age or older.\n* For BKV, ADV or CMV infections: Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using bone marrow, peripheral blood stem cells or single or double umbilical cord blood. For JC virus and COVID19 infection: no prior hematopoietic stem cell transplantation (HSCT) is required.\n* For BKV infection, patients need to have polymerase chain reaction (PCR) positive for BKV (in peripheral blood or urine) with consistent clinical symptoms.\n* For ADV infection, patients need to have PCR positive for ADV in peripheral blood AND\u002FOR patients need to fit criteria of probable or definitive adenovirus organ disease.\n* For CMV infection, patients need to have PCR positive for CMV in peripheral blood AND\u002FOR patients need to fit criteria of probable or definitive CMV disease.\n* For JCV, patients need to have documented JC viral encephalitis or JC end-organ disease.\n* For COVID-19 infection, patients need to have COVID-19 related pneumonia\u002Facute respiratory distress syndrome (ARDS) to be enrolled, defined as patients with a positive COVID-19 test (bronchoalveolar lavage \\[BAL\\], nasal or pharyngeal) and radiological and clinical signs of pneumonia or ARDS.\n* Written informed consent from patient or designated power of attorney.\n* Subjects are also are required to consent to PA17-0483 for long term follow up per the guidelines set forth by the Food and Drug Administrations' (FDA's) Biologic Response Modifiers Advisory Committee (BRMAC).\n* Negative pregnancy blood test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use at least two forms of birth control during the study and for at least 6 months after stopping treatment. Acceptable forms of birth control include intrauterine device (IUD), hormonal methods (birth control pills, injections, and implants), condoms, diaphragms, tubal ligation, or vasectomy.\n\nExclusion Criteria:\n\n* Patients who have received anti-thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or campath within 28 days of enrollment.\n* Patients with other uncontrolled infections (excluding human immunodeficiency virus \\[HIV\\]\u002Facquired immunodeficiency syndrome \\[AIDS\\]). For bacterial infections, patients must be receiving definitive therapy and have signs of improving infection prior to enrollment as determined by the principal investigator (PI). For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have signs of improving infection prior to enrollment as determined by the PI.\n* Patients with active steroid refractory graft versus host disease (GVHD).\n* Patients on immunosuppressive therapy other than tacrolimus, sirolimus or steroids\n* Active and uncontrolled relapse of malignancy. Patients with controlled malignancy on maintenance therapy would be eligible for the study.",{"count":170,"type":20},30,[83],"This phase I trial tests the feasibility and safety of genetically modified cytotoxic T-lymphocytes in controlling infections caused by adenovirus (ADV), BK virus (BKV), cytomegalovirus (CMV), JC virus (JCV), or COVID-19 in immunocompromised patients with cancer. Viral infections are a leading cause of morbidity and mortality after hematopoietic stem cell transplantation, and therapeutic options for these infections are often complicated by associated toxicities. Genetically modified cytotoxic T-lymphocytes (CTLs) are designed to kill a specific virus that can cause infections. Depending on which virus a patient is infected with (ADV, BKV, CMV, JCV, or COVID-19), the CTLs will be designed to specifically attack that virus. Giving genetically modified CTLs may help to control the infection.",[174,25,175,176,59,177,178],"Adenovirus Infection","Cytomegaloviral Infection","Hematopoietic and Lymphoid Cell Neoplasm","Malignant Solid Neoplasm","Symptomatic COVID-19 Infection Laboratory-Confirmed","2026-04-13",{"date":181,"type":34},"2026-04-16",{"date":183,"type":34},"2023-01-06",{"date":185,"type":20},"2027-01-31",{"name":72,"class":41},{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":197,"conditions":198,"keywords":203,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":4},"100623204","id-entity-trial--evaluating-serial-t-id-monitoring-100623204","NCT07393594","ID-ENTITY Trial- Evaluating Serial T-ID Monitoring","A Prospective, Multicenter, Observational Study Evaluating Serial T-ID Monitoring for the Prevention of CMV Disease and BK Virus-Associated Nephropathy Following Kidney Transplantation","ID-ENTITY","Inclusion Criteria:\n\n* Participants must meet all the following criteria:\n\n  * Written informed consent and HIPAA authorization obtained prior to any study-related data collection.\n  * Age ≥18 years at the time of enrollment.\n  * Recipient of a kidney transplant, including:\n  * Primary or repeat kidney transplantation\n  * Living-donor or deceased-donor transplantation\n  * At 1 month post-kidney transplant at the time of enrollment.\n  * Receiving maintenance immunosuppressive therapy per institutional standard of care.\n  * Selected by the treating provider to undergo TRAC testing as part of usual post-transplant clinical monitoring.\n\nExclusion Criteria:\n\n* Recipient of a combined organ transplant involving a non-renal solid organ (e.g., kidney-liver, kidney-heart) and\u002For islet cell transplantation.\n* History of prior non-renal solid organ transplantation or islet cell transplantation.\n* Known pregnancy at the time of enrollment.\n* Known active viral infection at enrollment with any of the following:\n* Hepatitis B surface antigen (HBsAg)-positive\n* Hepatitis B virus (HBV) nucleic acid testing (NAT)-positive\n* Human immunodeficiency virus (HIV) infection or HIV NAT-positive\n* \\*Known active BK virus-associated nephropathy (BKVAN) or CMV disease at the time of enrollment.\n* Medical, psychiatric, or social condition that, in the opinion of the Investigator, would interfere with the participant's ability to provide informed consent or comply with study procedures.\n* Concurrent participation in another investigational biomarker study designed to evaluate clinical utility of post-transplant molecular diagnostics.\n\n  * Participants with asymptomatic or low-level viral replication detected during routine clinical monitoring are eligible, provided there is no evidence of established CMV disease or BK virus-associated nephropathy at enrollment.",{"count":196,"type":20},1000,"To evaluate the association between time-updated CMV and BK viral loads measured monthly by T-ID and the risk of CMV disease and\u002For biopsy-proven BK virus-associated nephropathy (BKVAN) during the first 12 months following kidney transplantation, accounting for the net immune environment (TTV viral load) and allograft injury (donor-derived cell-free DNA, dd-cfDNA).",[199,200,25,201,202],"Kidney Diseases","Kidney Injury","CMV","TTV Virus",[204,205,206,207,208,209,210],"Biomarkers testing","Kidney transplant rejection","T-ID Assay","TRAC Assay cell free DNA","Biopsy","dd-cfDNA","T-ID","2026-02-20",{"date":213,"type":34},"2026-02-24",{"date":215,"type":20},"2026-03-31",{"date":217,"type":20},"2028-10-30",{"name":219,"class":162},"Transplant Genomics, Inc.",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":42},"100459564","new-therapeutic-approach-against-bk-virus-infection-based-on-monoclonal-antibodies-100459564","NCT05264259","New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies","AcMBK","Inclusion Criteria:\n\n* BK positive\n* adult\n* ok to participed to research\n\nExclusion Criteria:\n\n* under guardianship\n* under curatorship\n* opposed to research\n* deprived of liberty",{"count":51,"type":20},"BK virus (BKV) infection has a major negative impact on transplant recipients. No BKV-specific antiviral therapy is available, so there is an urgent need to develop new anti-BKV preventive and therapeutic strategies.",[25],"2025-08-04",{"date":232,"type":34},"2025-08-08",{"date":234,"type":34},"2022-09-05",{"date":236,"type":20},"2025-12-01",{"name":238,"class":41},"University Hospital, Strasbourg, France",{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":246,"enrollmentInfo":4,"targetDuration":4,"studyType":247,"phases":4,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":253,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":257,"locationsCount":4},"100600984","tetravi-expanded-access-program-100600984","NCT07104591","TETRAVI Expanded Access Program","Expanded Access Use of Multivirus-Specific Cytotoxic T-Lymphocytes for Pediatric Patients With EBV, CMV, Adenovirus, or BK Virus Infections Post Allogeneic Stem Cell Transplant","Inclusion Criteria:\n\n* Patients \\\u003C18 years of age.\n* Patients who have undergone myeloablative or non-myeloablative allogeneic HSCT or CAR T therapy in the Sate of Texas (USA).\n* Have persistent, increasing, or recurrent infections with EBV, CMV, adenovirus, or BK virus despite standard treatment.\n* Treating physician must be based in Texas.\n* Must obtain IRB approval and submit a protocol to FDA with Letter of Authorization from Baylor.\n\nExclusion Criteria:\n\n* Patients with active uncontrolled infections unrelated to the viruses mentioned.\n* Use of certain immunosuppressive agents within 28 days.\n* Serious uncontrolled medical conditions or relapse of underlying disease.","17 Years","EXPANDED_ACCESS","This Expanded Access Program (EAP) allows qualified physicians within Texas to obtain access to multivirus-specific cytotoxic T lymphocytes (VSTs) developed under Baylor College of Medicine's TETRAVI program (NCT04013802) for the treatment of persistent or recurrent infections with EBV, CMV, adenovirus, or BK virus in pediatric patients being treated in Texas who have received allogeneic stem cell transplants and have no other suitable therapeutic options.",[250,87,174,25,59,251,252],"Epstein-Barr Virus Infection","Viral Infections Post-Transplant","Post-Allogeneic Stem Cell Transplant Complications","AVAILABLE","2025-07-29",{"date":256,"type":34},"2025-08-05",{"name":258,"class":41},"Baylor College of Medicine",{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":16,"minAge":266,"maxAge":267,"enrollmentInfo":268,"targetDuration":4,"studyType":52,"phases":270,"briefSummary":84,"conditions":271,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":42},"100587323","phase-1-r-mvst-cells-for-treatment-of-viral-infections-in-children-and-young-adults-100587323","NCT06926894","R-MVST Cells for Treatment of Viral Infections in Children and Young Adults","Single Center Phase I Study of Adoptive Immunotherapy of Refractory Viral Infection With ex Vivo Expanded Rapidly Generated Virus Specific T (R-MVST) Cells for Immunodeficient Children and Young Adults","Inclusion Criteria:\n\n* Children and young adults (3 months to \\\u003C26 years) of all ethnic groups will be eligible for the treatment\n* Patients with history of HCT or SOT who demonstrate evidence of viral reactivation and\u002For infection manifesting as end-organ or systemic disease due to one or more of the following viruses: EBV, CMV, ADV or BK virus and suboptimal response to the standard of care therapy.\n* Recurrent or Multiple Viral Infection. RVI defined as occurrence of more than one episode of reactivation that required intervention or symptomatic disease in recipient of allogeneic HCT that required standard of care treatment. MVI defined as more than one virus reactivating (defined by PCR positivity) or causing symptomatic systemic or end-organ disease. At least one of those viral reactivations required standard of care intervention. No standard of care therapy is defined for ADV and BK. Patients with multiple infections\u002Freactivations will be eligible as long as at least one of those viral infections meet the criterium of \"refractory\".\n\nExclusion Criteria:\n\n* Patients with other uncontrolled infections, except for CMV, EBV, ADV or BK. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to the day of infusion. For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to R-MVST infusion. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.\n* Patients who receive corticosteroids at ≥ 0.5mg\u002Fkg prednisone or equivalent.\n* Patients who received anti-thymocyte globulin (ATG, Alemtuzumab (Campath), or other T-Cell immunosuppressive monoclonal antibodies in the last 28 days.\n* Patients who received methotrexate, or other antimetabolite-type immunosuppressants that are toxic to proliferating T cells in the last 7 days.\n* Patients who received extracorporeal photopheresis within the last 28 days.\n* Patients who received checkpoint inhibitor agents (e.g., nivolumab, pembrolizumab, ipilimumab) within 3 drug half-lives of the most recent dose to the infusion of R-MVST.\n* Received donor lymphocyte infusion in last 28 days.\n* Evidence of GVHD ≥ grade 2\n* Evidence of biopsy-proven acute rejection in SOT recipients\n* Active and uncontrolled relapse of malignancy\n* Patients who are pregnant, or breastfeeding.\n* Female of childbearing potential, or male with a female partner of childbearing potential, unwilling to use a highly effective method of contraception.\n* Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients who have received investigational (IND) product within 14 days of infusion of the the R-MVST cells.\n* Unable or unwilling to receive infusions at Morgan Stanley Children's Hospital.","3 Months","26 Years",{"count":269,"type":20},18,[83],[272,87,88,25,273],"Epstein-Barr Virus","Immune Deficiency",{"date":275,"type":34},"2025-07-31",{"date":277,"type":34},"2025-04-20",{"date":279,"type":20},"2030-12",{"name":99,"class":41}]