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A plain-language summary of the goals, design and what participants do
This clinical trial is focused on helping patients who have undergone an allogeneic hematopoietic stem cell transplant and are experiencing viral infections that do not respond to regular drug treatments. The viruses being studied include Cytomegalovirus (CMV), Adenovirus, Epstein-Barr virus (EBV), and BK virus. These infections can be particularly challenging for young patients, aged 0 to 30 years, who have received a stem cell transplant.
The treatment being tested in this study involves a special type of cell therapy using virus-specific T-cells, which are a kind of immune cell. These T-cells are selected from a family donor and are designed to target and fight the specific viruses causing the infections. The treatment is given as a solution through an intravenous infusion, which means it is delivered directly into the bloodstream.
The main goal of the study is to evaluate the safety of this cell therapy. Participants will receive the treatment and be monitored for any changes in their health, including any side effects or improvements in their condition. The study will also look at how well the treatment works in reducing the viral infections and improving the overall health of the participants. The trial is expected to continue until July 2025.
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
9 criteria
4 criteria
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Cytomegalovirus (CMV) infection is caused by a common virus that can infect almost anyone. Once infected, the virus remains in the body for life, often without causing symptoms. However, in individuals with weakened immune systems, such as those who have undergone a stem cell transplant, CMV can reactivate and lead to serious health issues. The virus can affect various organs, leading to symptoms like fever, fatigue, and inflammation. In severe cases, it can cause damage to the liver, lungs, and other organs.
Adenovirus infection is caused by a group of viruses that can affect the respiratory tract, eyes, intestines, and urinary tract. These infections are common and can occur in people of all ages, but they are more severe in individuals with weakened immune systems. Symptoms can range from mild respiratory issues to severe pneumonia, depending on the virus type and the individual's health. In immunocompromised patients, adenovirus can spread to multiple organs, leading to more serious complications.
Epstein-Barr virus (EBV) is a member of the herpesvirus family and is best known for causing infectious mononucleosis. After the initial infection, the virus remains dormant in the body and can reactivate, especially in those with weakened immune systems. Reactivation can lead to various health problems, including fever, sore throat, and swollen lymph nodes. In some cases, EBV reactivation can contribute to the development of certain cancers and other serious conditions.
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