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BK Virus Infection clinical trials

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NCT ID: NCT06219616 Recruiting - Clinical trials for Kidney Transplant Infection

Prediction of BK Virus Reactivation in Kidney Transplant Recipient

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

There has been no effective predicting tool to accurately predict BKV reactivation after kidney transplantation. The aim is to elucidate the use of flow cytometric analysis for both intracellular cytokines and surface activation markers for BKV-specific T cell response in kidney transplant recipients.

NCT ID: NCT05618275 Recruiting - BK Virus Infection Clinical Trials

Role of Neutralizing Antibodies in the Prediction and Treatment of BK Virus Infection in Hematopoietic Stem Cell Allograft Patients at the Pediatric Oncology-hematology Department of the HUS

BKV-Allograf
Start date: January 1, 2020
Phase:
Study type: Observational

The BK virus (BKV) belongs to the Polyomaviridae family. The primary infection, generally asymptomatic, occurs during childhood. The virus then persists in latent form in the body, mainly in the epithelial cells of the kidney and urinary tract. Cellular immunosuppression favors BKV replication. It is responsible for pathologies of the renal-urinary tract such as BKV-associated nephropathy (BKVAN) in kidney transplant recipients, hemorrhagic cystitis (HC) in hematopoietic stem cell (HSC) recipients or ureteral stenosis. To date, there is no specific antiviral treatment against BKV. The management of patients is essentially symptomatic and requires a multidisciplinary approach. It is therefore necessary to identify early prognostic markers for the occurrence of CH and to develop new therapeutic strategies.

NCT ID: NCT05511779 Recruiting - Clinical trials for Kidney Transplantation

Study to Confirm of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation

Start date: October 14, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase II, multicenter, open-label, randomized, standard of care (SOC) controlled, multiple ascending dose study to assess the safety and tolerability of IV Brincidofovir (BCV) in subjects with BKV infection after kidney transplantation. The study will be conducted at multiple study sites in several countries including Australia and Japan. Subjects who meet eligibility criteria will be enrolled in the study and will be randomized and assigned to BCV or SOC (defined as use of the same immunosuppressant administered during prescreening) before receipt of the first dose of study drug in both the Dose Escalation Phase and the Expansion Phase.

NCT ID: NCT05183490 Recruiting - Clinical trials for Cytomegalovirus Infections

R-MVST Cells for Treatment of Viral Infections

Start date: May 3, 2022
Phase: Phase 1
Study type: Interventional

The primary objective is to determine the safety and feasibility of administering R-MVST cells to patients with refractory viral reactivation and/or 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. Secondary 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.

NCT ID: NCT05101213 Recruiting - Clinical trials for Malignant Solid Neoplasm

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

Start date: January 6, 2023
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT05042076 Recruiting - Clinical trials for Kidney Transplant Infection

BK With VST for Kidney Transplant Patients

Start date: December 16, 2021
Phase: Phase 1
Study type: Interventional

This study measures the safety, feasibility, and efficacy of viral-specific T cells (VST) against BK Virus (BKV) in adult kidney transplant recipients. Participants are expected to be on study for 52 weeks.

NCT ID: NCT04542733 Recruiting - Clinical trials for Kidney Transplant Infection

The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus in Treatment of BK Virus Infection in Kidney Transplantation Recipient

ELF
Start date: February 10, 2021
Phase: N/A
Study type: Interventional

BK virus infection is one of the causes of renal allograft loss in the current era. Reduction of immunsuppression is the only intervention that prooved to be effective in treating of BK virus in kidney transplant recipient. However, there are evidences from retrospective and prospective studies showed that leflunomide and mTOR inhibitor such as everolimus or sirolimus have positive outcomes in treatment of BK virus in kidney tranplant recipient. The investigators conduct the RCT to compare the efficacy of leflunomide and mTOR inhibitor everolimus, in treatment of BK virus infected patients who do not respond to immunosuppression reduction.

NCT ID: NCT03576014 Recruiting - Clinical trials for Cytomegalovirus Infections

Evaluate Tolerability and Safety of BD03 for Prevention of CMV and BKV Reactivation in Kidney Transplant Recipient

Start date: April 27, 2018
Phase: Phase 1
Study type: Interventional

This study is a phase I, open-label study to determine recommended phase 2 dose (RP2D) for the BD03 vaccination in kidney transplant recipients. The recommended dose will be selected based on the safety and tolerability profiles observed.

NCT ID: NCT02479698 Recruiting - Clinical trials for Human Immunodeficiency Virus

Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus

Start date: July 23, 2015
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well donor cytotoxic T lymphocytes work in treating patients with malignancies with BK and/or 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/or JC virus.