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Study on Treating Resistant Viral Infections in Stem Cell Transplant Patients Using Allogeneic Multivirus-Specific T Cells

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on treating patients who have undergone a type of procedure called allogeneic stem cell transplantation and are now facing viral infections that do not respond to standard antiviral treatments. The viruses being studied are cytomegalovirus (CMV), Epstein-Barr virus (EBV), and adenovirus (AdV). The treatment being tested involves using special cells called allogeneic multivirus-specific T cells. These T cells are designed to target and fight the specific viruses mentioned. The study will also include a comparison with a placebo to evaluate the effectiveness of the T cell treatment.

The purpose of the study is to assess how well the T cell treatment works in clearing the viral infections in patients who have not responded to other treatments. Participants in the study will receive the T cell treatment through an infusion, which is a method of delivering the treatment directly into the bloodstream. The study will monitor the patients over a period of time to see if the viral infections are reduced or cleared and to observe any side effects or changes in health status.

Throughout the study, various health indicators will be checked, such as the presence of the virus in the blood and any symptoms related to the infections. The study will also look at the overall health and survival of the patients, as well as any potential side effects from the treatment. The goal is to determine if the T cell treatment can provide a new option for patients with these challenging viral infections after stem cell transplantation.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age and medical condition.

    Written informed consent is required from the patient or their legal representative.

  2. Step 2

    Initial assessment

    A comprehensive assessment is conducted, including physical examination and laboratory tests.

    Baseline measurements are taken, such as viral load and T-cell phenotyping.

  3. Step 3

    Treatment administration

    The treatment involves an intravenous infusion of allogeneic multivirus-specific T cells.

    The infusion is designed to target viral infections that are resistant to standard antiviral treatments.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring occurs from Day 0 to Week 8, including vital signs and adverse event documentation.

    Weekly blood samples are taken to assess changes in viral load and T-cell activity.

  5. Step 5

    Evaluation of outcomes

    Primary outcomes include the percentage of patients achieving viral clearance and progression rates.

    Secondary outcomes involve the incidence of graft-versus-host disease and changes in clinical symptoms.

  6. Step 6

    Extended follow-up

    Follow-up continues until Week 15 to monitor long-term effects and document any additional treatments.

    Overall survival and quality of life assessments are conducted at the end of the follow-up period.

Who can join the trial?

5 criteria

  • Patients must be adults or children older than 2 months who have had a **hematopoietic stem cell transplantation (HSCT)**. This is a procedure where a patient receives blood-forming stem cells.
  • Patients must have a new or reactivated infection with **CMV (Cytomegalovirus)**, **EBV (Epstein-Barr Virus)**, or **AdV (Adenovirus)**. These are types of viruses that can cause illness.
  • The infection must not have improved after two weeks of standard antiviral treatment. This means the amount of virus in the blood has not decreased significantly, as shown by a test called **quantitative blood PCR analysis**.
  • The original donor of the stem cells must be available and have an immune response to the virus causing the infection. This means the donor's immune system can recognize and fight the virus.
  • The patient or their legal representative must provide **written informed consent**. This means they agree to participate in the study after being informed about it.

Who cannot join the trial?

5 criteria

  • Patients who have not undergone a procedure called HSCT, which stands for Hematopoietic Stem Cell Transplantation. This is a treatment that replaces damaged or diseased bone marrow with healthy stem cells.
  • Patients who do not have a new or reactivated infection with viruses like CMV (Cytomegalovirus), EBV (Epstein-Barr Virus), or AdV (Adenovirus). These are types of viruses that can cause infections, especially in people with weakened immune systems.
  • Patients whose viral infections are not resistant to standard antiviral treatments. This means that the usual medicines used to treat these infections are still working for them.
  • Patients who are not between the ages of 2 and 18 years old.
  • Patients who are not part of a vulnerable population, which means they do not have additional health or social factors that make them more at risk.
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Investigated drugs

Multispecific T Cells are a type of therapy used in this clinical trial. These T cells are specially designed to target and fight against specific viruses, such as CMV (Cytomegalovirus), EBV (Epstein-Barr Virus), and AdV (Adenovirus). The therapy involves transferring these T cells into patients who have undergone allogeneic stem cell transplantation and are experiencing viral infections that do not respond to standard chemotherapy treatments. The goal is to help the patient's immune system better recognize and eliminate these viruses.

What is already known about the treatment

Multispecific T Cells – This treatment involves the administration of specially engineered T cells, delivered intravenously, to target and combat specific viral infections. Currently, it is being studied in clinical trials, particularly for patients who have undergone stem cell transplantation and are experiencing viral infections that do not respond to standard antiviral medications. The main therapeutic use is to treat infections caused by viruses like CMV, EBV, and AdV in these patients. At the molecular level, these T cells are designed to recognize and attack cells infected with these viruses, enhancing the body's immune response. This treatment falls under the category of immunotherapy, as it utilizes the body's immune system to fight infections.

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, it can reactivate, especially in individuals with weakened immune systems, such as those who have undergone stem cell transplantation. Reactivation can lead to symptoms like fever, fatigue, and inflammation of various organs. The virus spreads through bodily fluids and can be detected through blood tests. In severe cases, it may affect the eyes, lungs, liver, esophagus, stomach, and intestines.

  • Epstein-Barr Virus Infection

    Epstein-Barr Virus (EBV) infection is a common viral infection that often causes infectious mononucleosis, also known as "mono" or the "kissing disease." The virus is transmitted through saliva and can cause symptoms such as fever, sore throat, swollen lymph nodes, and fatigue. After the initial infection, the virus remains dormant in the body and can reactivate, particularly in individuals with compromised immune systems. Reactivation can lead to more serious conditions, including certain types of cancer. The infection is typically diagnosed through blood tests that detect antibodies to the virus.

  • 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, often resulting in symptoms like sore throat, fever, cough, and eye redness. In individuals with weakened immune systems, such as those who have undergone stem cell transplantation, the infection can become severe and spread to other parts of the body. The virus is highly contagious and spreads through close personal contact, respiratory droplets, and contaminated surfaces. Diagnosis is usually made through laboratory tests that detect the virus in samples from the infected area.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512321-84-00Estimated enrolment111 patientsSponsorMedical Center - University Of Freiburg

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