Ongoing Clinical Trials for Epstein-Barr Virus Infection
There are currently 4 clinical trials investigating new approaches to prevent and treat Epstein-Barr virus infection and its complications. These studies are taking place across Europe, including Belgium, France, Germany, Italy, and the Netherlands. The trials focus on various aspects including prevention in transplant patients, treatment of resistant infections, and management of fatigue and cancer associated with the virus.
Clinical trial locations
- Belgium
- France
- Germany
- Italy
- Netherlands
Evaluating Somatostatin Receptor 2 Expression Using [68Ga]Ga-DOTA-TOC PET/CT Imaging in Patients with Epstein-Barr Virus Associated Nasopharyngeal Carcinoma
This study focuses on improving imaging techniques for nasopharyngeal carcinoma, a type of cancer that develops in the upper part of the throat behind the nose and is associated with Epstein-Barr virus infection. The trial takes place in the Netherlands and investigates whether a special type of scan can help doctors better visualize and understand these tumors.
Main inclusion criteria: Participants must be at least 18 years old with stage IB-IVA nasopharyngeal carcinoma that is positive for Epstein-Barr virus. They should be planned to receive either induction chemotherapy or chemoradiation therapy. Previous tumor tissue samples must be available for testing, and women of childbearing potential must have a negative pregnancy test.
Main exclusion criteria: Patients cannot participate if they have had allergic reactions to octreotide or the imaging agent, are pregnant or breastfeeding, have severe kidney problems, cannot lie still during the scan, have received radiation or chemotherapy within 2 weeks, have other active cancers requiring treatment, have uncontrolled diabetes, or are taking medications that interfere with the imaging agent.
Study focus: The trial uses a specialized imaging substance called [68Ga]Ga-DOTA-TOC administered through PET/CT scans performed before and after cancer treatment. This radioactive tracer binds to specific receptors on tumor cells, allowing doctors to visualize the cancer more clearly and assess how it responds to treatment. The imaging technique may help determine which patients could benefit from certain targeted therapies in the future.
Investigational substance: [68Ga]Ga-DOTA-TOC is a radiopharmaceutical imaging agent that binds to somatostatin receptor 2 on tumor cells, making them visible on PET/CT scans.
Study on Rituximab for Preventing Epstein-Barr Virus Infection and Lymphoproliferative Disorders in EBV-Negative Kidney Transplant Patients
This French study examines whether early treatment with Rituximab can prevent initial infection with Epstein-Barr virus and related complications in kidney transplant recipients. The trial specifically targets patients who have never been infected with the virus but receive a kidney from a donor who has the virus.
Main inclusion criteria: Participants must be at least 18 years old receiving a kidney transplant or combined kidney-pancreas transplant. They must be negative for Epstein-Barr virus antibodies, confirmed from 6 months before transplant to the day of transplant. The kidney donor must be positive for the virus. Children older than 2 years but younger than 18 are also eligible. Women must have a negative pregnancy test and agree to use contraception.
Main exclusion criteria: Patients who are already positive for Epstein-Barr virus cannot participate, nor can those receiving kidneys from donors who are negative for the virus. Patients outside the specified age ranges or not meeting the study criteria are excluded.
Study focus: The trial investigates whether giving Rituximab early after transplant can prevent the virus from establishing an initial infection and reduce the risk of post-transplant lymphoproliferative disorder, a serious complication involving abnormal growth of immune cells. Participants are randomly assigned to receive either Rituximab or placebo and are monitored for up to 5 years with regular blood tests to check for viral infection and immune function.
Investigational drug: Rituximab is a monoclonal antibody administered by intravenous infusion that targets specific immune cells to help prevent viral infection and related complications.
Study on the Effectiveness of 2LEBV and 2LXFS for Reducing Fatigue in Patients with Epstein-Barr Virus Infection
This Belgian trial focuses on treating one of the most common and debilitating symptoms of Epstein-Barr virus infection: persistent fatigue. The study compares two experimental treatments against placebo to determine if they can effectively reduce exhaustion in infected patients.
Main inclusion criteria: Participants must be at least 12 years old with significant fatigue lasting at least one month. They must have at least two additional symptoms such as fever, sore throat, swollen lymph nodes, muscle pain, headaches, sleep disorders, or digestive problems. Blood tests must confirm positive serology for Epstein-Barr virus showing current or past infection. Participants must agree to have blood tests and lymphocyte typing.
Main exclusion criteria: Individuals without confirmed Epstein-Barr virus infection cannot participate. Specific age requirements apply, though both males and females are eligible.
Study focus: The trial compares two investigational medications, 2LEBV and 2LXFS, to determine their effectiveness in reducing fatigue severity compared to placebo. This is a double-blind study lasting six months, meaning neither participants nor researchers know who receives which treatment. Participants complete regular questionnaires assessing fatigue levels, physical activity, motivation, and mental fatigue.
Investigational drugs: 2LEBV and 2LXFS are oral medications taken through the mouth’s mucous membranes, currently under investigation for their potential to alleviate fatigue in patients with Epstein-Barr virus infection.
Study on Treating Resistant Viral Infections in Stem Cell Transplant Patients Using Allogeneic Multivirus-Specific T Cells
This international trial spans Belgium, France, Germany, Italy, and the Netherlands, investigating a novel immune cell therapy for patients who have undergone stem cell transplantation and developed viral infections that don’t respond to standard antiviral drugs. The study targets three viruses including Epstein-Barr virus.
Main inclusion criteria: Participants must be adults or children older than 2 months who have undergone hematopoietic stem cell transplantation. They must have new or reactivated infection with cytomegalovirus, Epstein-Barr virus, or adenovirus that has not improved after two weeks of standard antiviral treatment. The original stem cell donor must be available and have an immune response to the specific virus causing the infection.
Main exclusion criteria: Patients who have not undergone stem cell transplantation cannot participate. Those without confirmed viral infections resistant to standard treatments, or whose infections are responding to usual antiviral medications, are excluded.
Study focus: The trial tests whether specially engineered immune cells called multivirus-specific T cells can help clear viral infections that resist standard treatments. These T cells are designed to recognize and attack cells infected with the target viruses. The treatment is delivered through intravenous infusion, and patients are monitored closely for up to 15 weeks to assess viral clearance, side effects, and overall health outcomes.
Investigational treatment: Multivirus-specific T cells are specially engineered immune cells that target and fight cytomegalovirus, Epstein-Barr virus, and adenovirus infections in transplant patients with weakened immune systems.
Summary
The four ongoing clinical trials for Epstein-Barr virus infection demonstrate diverse approaches to managing different aspects of the disease. One notable observation is the concentration of research on transplant-related complications, with two studies focusing specifically on transplant recipients. The Netherlands hosts research on virus-associated cancer imaging, Belgium investigates fatigue management, France examines infection prevention in transplant patients, and multiple countries collaborate on treating resistant infections in stem cell transplant recipients.
The trials employ various therapeutic strategies including advanced imaging techniques, preventive immunotherapy with Rituximab, experimental fatigue treatments with 2LEBV and 2LXFS, and engineered immune cell therapy. This range reflects the complexity of Epstein-Barr virus infection and its varied manifestations, from persistent fatigue to cancer development and life-threatening infections in immunocompromised patients. The international collaboration, particularly evident in the multivirus-specific T cell trial spanning five countries, highlights the importance of this research area in transplant medicine.
