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Study on Virus-Specific T-Cells for Treating Resistant Viral Infections in Young Patients After Stem Cell Transplant

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What is this study about?

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.

1 enrollment

The patient is enrolled in the study after meeting specific criteria, including having received an allogeneic hematopoietic stem cell transplant and experiencing a viral infection resistant to standard treatments.

Informed consent is obtained from the patient or their legal guardian.

2 treatment preparation

Virus-specific T lymphocytes are selected in vitro from a family donor. These are special immune cells that target specific viruses.

The preparation involves ensuring the absence of severe uncontrolled infections and other health conditions that could interfere with the treatment.

3 treatment administration

The patient receives the treatment through intravenous use. This means the solution is administered directly into a vein.

The treatment consists of a solution for infusion, which is a liquid containing the virus-specific T lymphocytes.

4 monitoring and follow-up

The patient is monitored for any adverse events, which are significant changes in vital signs or organ function.

Regular assessments are conducted to evaluate organ health, overall survival, and the effectiveness of the immune response against the virus.

The study aims to collect data on any changes in the level of virus in the blood, known as viremia.

5 study completion

The study is expected to conclude by July 24, 2025.

Final evaluations are conducted to assess the long-term effects and safety of the treatment.

Who Can Join the Study?

  • The patient must have had an allogeneic transplant, which means they received stem cells from a donor.
  • The patient or their parent/legal guardian must provide informed consent, which is an agreement to participate after understanding the study.
  • The patient must be between the ages of 0 and 30 years.
  • The patient must have a viral infection or reactivation of viruses like CMV, EBV, ADV, or BK.
  • The patient should not have any other severe infections that are not controlled.
  • The patient should have a life expectancy of more than 30 days.
  • The patient should not have Graft versus Host Disease (GvHD) that is not controlled. GvHD is a condition where the donor cells attack the patient’s body.
  • The patient should not have acute kidney damage that is not related to the viral infection. This means their creatinine level should not be more than three times the normal value for their age.
  • The patient should not have severe acute liver injury that is not related to the viral infection. This means their direct bilirubin should not be more than 3 mg/dl, and their SGOT should not be more than 500 UI/L.

Who Cannot Join the Study?

  • Patients who have not received an allogeneic hematopoietic stem cell transplant. This is a type of transplant where stem cells are taken from a donor and given to the patient.
  • Patients who have not developed post-transplant viral reactivation. This means the virus has not become active again after the transplant.
  • Patients whose viral reactivation is not resistant to pharmacological therapies. This means the virus can still be treated with regular medicines.
  • Patients who are older than 30 years. The study is only for young patients between 0 and 30 years old.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
IRCCS Istituto Giannina Gaslini Genoa Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
28.09.2022

Trial locations

Virus-specific T-cell Therapy is a treatment being studied for its safety in treating certain resistant viral infections. This therapy involves using T-cells, a type of immune cell, that are specifically trained to target and fight viruses. These T-cells are selected in a laboratory from a family donor and are used to help the patient’s immune system combat infections like Adenovirus, Epstein-Barr virus, Cytomegalovirus, and BK virus. This approach is being tested in young patients who have undergone a type of stem cell transplant called allogeneic hematopoietic stem cell transplantation.

Investigated diseases:

Cytomegalovirus Infection – 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 – 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 Infection – 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.

Trial ID:
2024-518925-14-02
Protocol code:
PTC:VS-TC
NCT ID:
NCT05075837
Trial Phase:
Human Pharmacology (Phase I) – Other

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