Infectious Mononucleosis

Researchers are evaluating VK-2019 in adult patients with relapsed or refractory Epstein-Barr virus (EBV)-positive diffuse large B-cell lymphoma (DLBCL). This Phase Ib, open-label study aims to assess the safety and tolerability of VK-2019 given as a single agent. The trial includes biomarker assessments and follows patients for survival for up to three years. Participants receive daily oral doses of VK-2019 in one of three dose groups: 600 mg, 1200 mg, or 1800 mg. Each treatment cycle lasts 28 days and is repeated until disease progression or unacceptable toxicity occurs. Patients showing stable disease or better after three cycles may continue treatment, while those with progressive disease stop therapy. Dose adjustments may be made if unacceptable toxicity occurs. During the study, patients undergo response assessments every three cycles along with regular monitoring of safety and organ function. Researchers track the maximum tolerated dose and follow all patients for three years to assess survival outcomes. Treatment stops if consent is withdrawn, disease progresses, toxicity is unacceptable, or pregnancy is suspected.

Researchers are evaluating STAR0602, a selective T cell receptor targeting bifunctional antibody-fusion molecule, in adults with advanced solid tumors that are antigen-rich. This open-label, multicenter Phase 1/2 study aims to assess the safety, tolerability, and preliminary clinical activity of STAR0602 in participants with unresectable, locally advanced, or metastatic solid tumors where standard therapies are not effective or suitable. The study has two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1, STAR0602 is given intravenously to determine safety, the maximum tolerated dose, and the recommended dose for Phase 2. In Phase 2, participants receive STAR0602 at the established recommended dose to further evaluate safety and clinical activity. Clinical activity is measured by tumor response rates, duration of response, disease control, and progression-free survival. Participants will receive STAR0602 infusions in cycles lasting 28 days. Researchers will monitor safety by tracking dose-limiting toxicities, adverse events, and serious adverse events for up to three years. Tumor responses and survival outcomes are also assessed over this period. Pharmacokinetic measures and anti-drug antibody formation will be evaluated at specified cycles. The total study duration and follow-up can extend up to three years to gather comprehensive safety and activity data.

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 treatment's 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.

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 (8-12°C) 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 5×10^5/kg up to 1×10^6/kg. 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 1×10^6/kg to 1×10^8/kg. 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 method—starting with antibody tests followed by plasma EBV DNA testing for positive cases—and 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.

This research aims to compare the effects of remimazolam and propofol on recovery time, complications, and safety in adult patients undergoing ambulatory upper airway surgery under general anesthesia. The trial focuses on surgeries involving the nasal cavity, oral cavity, pharynx, and larynx, evaluating which anesthesia method may influence postoperative recovery quality. Participants are randomly assigned to either the Remimazolam group or the Propofol group. In the Remimazolam group, anesthesia is started and maintained by continuous infusion of remimazolam and remifentanil, with recovery supported by flumazenil. In the Propofol group, anesthesia uses continuous infusion of propofol and remifentanil via target concentration controlled infusion. Both groups receive rocuronium for muscle relaxation and sugammadex to reverse this effect after surgery. During the study, recovery times and adverse events are recorded at three stages: in the operating room, in the post-anesthesia care unit (PACU), and in the day surgery center. Assessments include eye opening time, extubation time, PACU transfer time, stay durations, pain scores, alertness levels, and safety monitoring over several hours following surgery. The primary outcome is the time until patients are fit for discharge, measured 15 minutes after surgery.

Researchers are evaluating whether the number of needle agitations during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) affects diagnostic accuracy in patients with enlarged mediastinal lymph nodes. This study aims to compare two needle agitation strategies to see if one improves diagnostic yield, tissue sample quality, and safety. The trial addresses the lack of high-level evidence about the best agitation technique and seeks to standardize procedural methods to optimize outcomes while maintaining safety. Participants will be randomly assigned to one of two needle agitation strategies during EBUS-TBNA: a low-range strategy with 10 to fewer than 30 agitations per needle pass (target about 20) or a high-range strategy with 30 to 60 agitations per pass (target about 45 to 50). All other procedural factors, such as needle type, number of passes, suction technique, and specimen handling, will be kept consistent between groups to isolate the effect of agitation number. Participants will undergo EBUS-TBNA as part of their clinical evaluation and have tissue samples measured for core length and assessed for diagnostic adequacy immediately after the procedure. Researchers will monitor for procedure-related complications to assess safety. The main outcome is diagnostic yield within 7 to 14 days after the procedure. The study starts in February 2026 and continues through December 2028, with participants closely followed during and shortly after the procedure.