Infectious Mononucleosis

This research aims to evaluate VK-2019 in adult patients with relapsed or refractory Epstein-Barr virus EBV-positive diffuse large B-cell lymphoma DLBCL who have previously undergone at least two systemic therapies. The study is a Phase Ib, open-label trial focusing on the safety and tolerability of VK-2019. It includes biomarker assessments to better understand treatment effects in this population with limited standard care options. Participants receive daily oral doses of VK-2019 in one of three dose escalation groups 600 mg, 1200 mg, or 1800 mg per day. Treatment cycles last 28 days and repeat until disease progression or unacceptable side effects occur. Patients who achieve stable disease or better after three cycles may continue therapy. Dose adjustments may be made if toxicity is observed. During the study, participants undergo response assessments every three cycles and are monitored for survival for up to three years. Researchers track safety measures including dose-limiting toxicities and organ function. Participants also complete scheduled laboratory tests and clinical evaluations to assess treatment impact and tolerability throughout the study period.

Researchers are evaluating STAR0602, a selective T cell receptor targeting bifunctional antibody-fusion molecule, in participants with advanced solid tumors that have high antigen levels. This open-label, multicenter Phase 12 study aims to assess the safety, tolerability, and early clinical activity of STAR0602 given alone and in combination with chemotherapy for these tumors, which have limited effective standard treatments. The trial includes participants with unresectable, locally advanced, or metastatic solid tumors, including specific subtypes like NSCLC and colorectal cancer. The study has two parts Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1, STAR0602 is given intravenously to determine the maximum tolerated dose and safety profile. Phase 2 uses the recommended dose from Phase 1 to further evaluate safety and preliminary effectiveness, measuring tumor responses and disease control. Chemotherapy drugs like Irinotecan and Docetaxel may be combined with STAR0602, and treatments are administered by infusion following defined cycles. Participants will undergo multiple assessments including safety monitoring for adverse events and serious adverse events up to three years. Researchers will measure tumor response rates, duration of response, disease control rate, progression-free survival, and other pharmacokinetic parameters. Study visits will include treatment administration, laboratory tests, and evaluations to track the therapys effects and tolerability over time. The total participation period may extend up to three years for follow-up and monitoring.

Researchers are evaluating the safety and immune response of an Epstein-Barr Virus EBV candidate vaccine called mRNA-1189 in healthy adults aged 18 to 30 years. This Phase 1, randomized, open-label study aims to understand how the vaccine performs when delivered through different methods and doses. The study is sponsored by ModernaTX, Inc. and focuses on both local and systemic reactions after vaccination. Participants will receive two injections of the mRNA-1189 vaccine on Days 1 and 57. These injections are administered either intradermally ID or intramuscularly IM at two different dose levels. Four study groups receive either Dose Level 1 or Dose Level 2 via ID or IM delivery. The vaccine is a sterile liquid designed for injection. During the study, participants will be monitored for adverse reactions and events through Day 225, including solicited local and systemic reactions up to Day 64 and medically attended events up to the study end. Blood samples will be taken on Days 1 and 85 to measure antibody responses, including binding antibody levels and seroconversion rates. The total participation duration extends to approximately 7.5 months to ensure thorough safety and immune response evaluation.

Researchers are evaluating the safety and feasibility of infusing donor-derived virus-specific T-cells selected by the cytokine capture system CCS in patients who have undergone hematopoietic stem cell transplantation HSCT and have treatment-resistant viral infections. This study focuses on infections caused by cytomegalovirus CMV, Epstein-Barr virus EBV, and adenovirus. The CCS technology has been used successfully in previous clinical studies in Germany and the UK. The study is conducted as a single-center, open-label, single-arm trial where donor-derived interferon-gamma IFN-B3 positive T-cells are generated and infused into HSCT recipients with viral infections. Six patients from the University Hospital of Basel will be included. If safety is confirmed, future studies will explore the treatments efficacy and expand its use to other pathogens and patient groups, including solid organ transplant recipients. Participants will receive the selected IFN-B3 positive T-cell infusions and be closely monitored. Researchers will assess the level of enriched IFN-B3 positive T-cells within 7 days and evaluate treatment efficacy at the same timepoint. Safety and viral response will be regularly checked during the study. The trial started in December 2014 and is expected to continue until December 2026.

Opportunistic infections caused by viruses such as Epstein Barr Virus EBV, Cytomegalovirus CMV, adenovirus AdV, and BK virus BKV pose serious risks for patients undergoing hematopoietic stem cell transplantation HSCT or those who are immunocompromised. These infections often lead to significant illness and death, particularly during the early period after transplant. Traditional antimicrobial drugs are used to prevent and treat these infections, but some patients develop resistance, making treatment challenging. This study evaluates the safety and effectiveness of using microbial-specific cytotoxic T lymphocytes CTLs to treat these infections in such vulnerable patients. In this trial, researchers prepare CTLs from a patients own or a donors blood by activating and enriching T cells with pathogen-specific antigens. The prepared CTLs are infused intravenously at doses ranging from approximately 1x105 to 1x106 cells per kilogram of body weight. Patients may receive repeated CTL infusions to combat microbial infections. The process of preparing the CTLs takes about 12 to 17 days. This phase III trial focuses on evaluating the safety and monitoring the antimicrobial effects of these infused CTLs. Participants will be followed closely after infusion with weekly visits for one month, then monthly for three months, and subsequently every three months until the study concludes. During these visits, doctors will assess safety using standard criteria for adverse events and monitor viral loads to evaluate treatment response. Additional evaluations include immune system recovery, incidence of graft-versus-host disease-like symptoms, and other potential infusion-related effects. The total study duration extends up to the end of 2030, allowing for long-term monitoring of participants health and immune status.

This research aims to evaluate whether using the Difflam Forte Anti-Inflammatory Throat Spray, containing benzydamine hydrochloride, can reduce the incidence and severity of postoperative sore throat POST in women undergoing gynecological surgery with general anesthesia using a laryngeal mask airway LMA. POST is a common issue caused mainly by mechanical injury to the airway mucosa during airway insertion, leading to inflammation and discomfort. The study will compare patients receiving Difflam spray after surgery to those receiving usual care with no intervention. Participants will be randomly assigned to one of two groups the study group will receive four sprays of Difflam to the back of the throat while awake in the post-anesthesia care unit, and the control group will receive no intervention. Questionnaires will be given to assess pain levels and any side effects 10 minutes and 4 hours after intervention. The trial will include 106 women undergoing surgery at a single hospital and will collect demographic and airway data during surgery. During the study, participants will be monitored for sore throat incidence and pain severity using a visual analog scale shortly after surgery and at 4 hours postoperatively. Side effects related to the spray will also be recorded. This information will help determine if Difflam spray is suitable for routine use to improve recovery and patient comfort after general anesthesia with LMA. The total study duration extends until the end of 2027.

This research aims to evaluate whether chewing gum and cold water gargling can ease common throat discomforts, such as sore throat and difficulty swallowing, experienced after bronchoscopy. The study compares these simple interventions against standard care to see if they improve patient comfort and satisfaction following the procedure. Participants will be randomly assigned to one of three groups chewing sugar-free xylitol gum for 15 minutes before bronchoscopy, gargling cold water 8-12C twice for 30 seconds each before the procedure, or receiving the usual care without additional treatments. The chewing gum and cold water gargle are supervised by researchers who provide instructions and ensure proper procedure. Participants symptoms and satisfaction will be assessed before bronchoscopy, then at 2 hours and 24 hours after the procedure. The 24-hour follow-up will be done by phone. Researchers will measure the severity of sore throat and swallowing difficulty along with patient satisfaction, aiming to understand if these interventions affect recovery and comfort. The study starts with standard fasting and includes routine education about bronchoscopy.

Researchers are evaluating EBV-TCR-T cell immunotherapy as a treatment for Epstein-Barr virus EBV infection occurring after allogeneic hematopoietic stem cell transplantation HSCT. This is a phase 1, multi-center, open-label study focused on assessing the safety and effectiveness of this therapy in patients with hematologic malignancies who develop EBV infection following HSCT. The study aims to provide important information on how this treatment works and its potential risks. Patients will receive one to three infusions of EBV-specific T cell receptor TCR T cells derived from their HSCT donors. These EBV-TCR-T cells are created by introducing a specific TCR into donor T cells through lentiviral transduction. The infused doses will escalate from 5105kg up to 1106kg. A second phase will adjust dosing based on pharmacokinetics and patient response data. This therapy is delivered intravenously and closely monitored. Participants will be followed for up to one year after treatment, during which researchers will monitor adverse events, changes in EBV-DNA levels, persistence of the infused cells, and cytokine concentrations. Dose-limiting toxicities and maximum tolerated doses will also be evaluated within the first 28 days. Additional outcomes include response rates, duration of response, incidence of EBV-related complications, and pharmacokinetic parameters of the therapy. Safety and effectiveness assessments will involve laboratory tests, clinical evaluations, and follow-ups throughout the study period.

Researchers are studying the safety and effectiveness of EBV-TCR-T cell immunotherapy in patients with Epstein-Barr virus EBV-associated hemophagocytic lymphohistiocytosis EBV-HLH or EBV infection. This phase I, multi-center, open-label trial aims to understand how well this treatment works and its safety profile. EBV is a common herpesvirus that can cause serious complications like EBV-positive B-cell lymphomas and chronic infections when not controlled. The treatment involves creating EBV-specific T cell receptor TCR T cells by introducing a restricted EBV-specific TCR into donor T cells using lentiviral transduction. Patients with EBV-HLH or EBV infection will receive infusions of these EBV-TCR-T cells in escalating doses ranging from 1106kg to 1108kg. The trial is designed as a single-arm study where all participants receive the investigational EBV-TCR-T cell therapy. Participants will be monitored for adverse events for up to one year after treatment. The study will also assess dose-limiting toxicity, maximum tolerated dose, changes in EBV-DNA levels, and pharmacokinetics of the EBV-TCR-T cells. Regular evaluations include measuring cytokine levels, viral DNA copies, and cell concentration over time to understand treatment effects and safety. The total study duration and follow-up last through one year post-treatment.

Researchers are evaluating new screening methods for nasopharyngeal carcinoma NPC in people at high risk, focusing on Epstein-Barr virus EBV associated biomarkers. This study compares plasma EBV DNA testing and BNLF2b total antibodies P85-Ab with the current standard two-antibody method VCA-IgA and EBNA1-IgA. The goal is to find the best initial screening approach that improves detection sensitivity while keeping accuracy high, which could reduce the need for invasive procedures and lower medical costs. Participants between 30 and 69 years old will have blood, nasopharyngeal swab, and saliva samples collected for testing various EBV biomarkers. The study will explore both a two-step screening methodstarting with antibody tests followed by plasma EBV DNA testing for positive casesand a single-step method where all tests are done simultaneously. Those identified as high-risk will undergo endoscopic examinations, with or without biopsy, to confirm findings. Participants will be followed and tested at the start, then again at 3 years and 10 years to measure the sensitivity, specificity, predictive values, and early diagnosis rates of each screening method. Researchers will also monitor death rates related to NPC and all causes. The study is designed to track these outcomes over a long period while ensuring participants can cooperate with ongoing follow-up to assess the screening strategies effectiveness and efficiency.