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Study on Preventing Cytomegalovirus Infection in Stem Cell Transplant Patients Using Cytolytic T Lymphocytes

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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 preventing Cytomegalovirus (CMV) infection in patients who have undergone a specific type of stem cell transplant known as hematopoietic stem cell transplantation (HSCT). This procedure is often used to treat various blood-related conditions, including some cancers. The study is particularly aimed at patients who have received transplants from family members with matching tissue types, known as HLA-identical familial donors, and who do not have any specific medication available to prevent CMV infection.

The treatment being studied involves the use of advanced cellular immunotherapy, specifically with Cytolytic T Lymphocytes (CTLs). These are special immune cells that can target and destroy virus-infected cells. The purpose of the study is to evaluate how effective this treatment is in reducing the occurrence of CMV infection within the first 100 days after the transplant. This is compared to historical data from similar patients who did not receive this treatment.

Participants in the study will receive the CTL treatment through an injection. The study will monitor the incidence of CMV infection and assess the need for further CMV treatment. It will also evaluate the presence of specific immune cells that remember the CMV virus, known as CMV-specific memory T lymphocytes. The study aims to provide valuable insights into the potential benefits of using CTLs for preventing CMV infections in this patient group.

The research process

The trial runs in 5 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, the patient must have received a hematopoietic stem cell transplant from a family donor who is a perfect match in terms of human leukocyte antigen (HLA).

    The donor must be screened and meet specific criteria, including being seropositive for cytomegalovirus (CMV).

    The patient must have a partial recovery of the hematopoietic implant, indicated by a specific count of neutrophils in the blood.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure the patient meets all inclusion criteria, such as being over 18 years old and having signed a written informed consent.

    A negative pregnancy test is required for women.

  3. Step 3

    Treatment phase

    The patient will receive antiviral prophylaxis with specific cytotoxic T lymphocytes (CTLs) to prevent CMV infection.

    This treatment aims to reduce the incidence of CMV infection within 100 days after the transplant.

  4. Step 4

    Monitoring and follow-up

    The patient's health will be monitored regularly to assess the presence of CMV infection, which is determined by measuring the viral load in the blood.

    The primary goal is to evaluate the efficacy of the treatment by checking the incidence of CMV infection at 100 days post-transplant.

  5. Step 5

    Evaluation of outcomes

    The study will assess the need for additional CMV treatment and evaluate the incidence of CMV-related disease.

    The presence of CMV-specific memory T lymphocytes will also be assessed as part of the study's secondary objectives.

Who can join the trial?

10 criteria

  • Adult patients over 18 years old, whether or not they have a blood-related cancer, who have received a transplant of blood-forming cells from a family donor with matching tissue type.
  • The donor will be checked to make sure they are suitable according to the criteria for blood-forming cell donors.
  • The donor must also sign a written agreement to participate before being included.
  • Patients who are not candidates to receive a medication called Letermovir.
  • The source of the blood-forming cells can be from the bloodstream or bone marrow.
  • Patients whose donor has been exposed to a virus called **CMV** (Cytomegalovirus).
  • Women must have a negative pregnancy test.
  • A written agreement to participate must be signed by the patient or their legal representative.
  • There must be some recovery of the blood-forming cells after the transplant, shown by a specific type of white blood cell count being above a certain level for at least three checks after the transplant.
  • Specific criteria for donors include being a tissue type match and having been exposed to **CMV**.

Who cannot join the trial?

6 criteria

  • Patients who have a different type of infection other than **Cytomegalovirus (CMV)**. CMV is a virus that can cause illness in people with weakened immune systems.
  • Patients who have not undergone an **allogeneic transplant**. This is a type of transplant where the donor and recipient are different people.
  • Patients who do not have an **HLA-identical familial donor**. HLA stands for Human Leukocyte Antigen, which is a protein on cells that helps the immune system recognize which cells belong in the body and which do not. An HLA-identical familial donor is a family member whose HLA matches the patient's.
  • Patients who are not within the specified age range for the study.
  • Patients who are not male or female, as the study includes both genders.
  • Patients who belong to a vulnerable population, as the study does not include vulnerable groups.
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Investigated drugs

CTLs (Cytotoxic T Lymphocytes) are a type of immune cell therapy used in this trial. These cells are specifically designed to target and destroy cells infected with the cytomegalovirus (CMV). The goal of using CTLs in this trial is to prevent CMV infection in patients who have undergone a hematopoietic stem cell transplant. This therapy is being tested to see if it can effectively reduce the incidence of CMV infection within 100 days after the transplant.

What is already known about the treatment

Antiviral Prophylaxis with Specific CTLs – This treatment involves the administration of specific cytotoxic T lymphocytes (CTLs) to prevent cytomegalovirus (CMV) infection in patients who have undergone HLA-identical familial allogeneic hematopoietic stem cell transplantation. Currently, this approach is being evaluated in clinical trials and is not yet widely available in standard medical practice. The main therapeutic indication is the prevention of CMV infection in a specific patient population where no pharmacological prophylaxis is available. The mechanism of action involves the use of CTLs to target and destroy cells infected with CMV, thereby reducing the incidence of infection. This treatment falls under the pharmacological classification of advanced cellular immunotherapy.

Investigated diseases

Cytomegalovirus Infection – This is a viral infection caused by the cytomegalovirus, which is a type of herpesvirus. It often remains dormant in the body after the initial infection, but can reactivate, especially in individuals with weakened immune systems. In the context of post allogeneic HLA-identical familial hematopoietic stem cell transplantation, the virus can cause significant complications. The infection may manifest with symptoms such as fever, fatigue, and muscle aches, but can also affect various organs if it progresses. Monitoring and managing the viral load is crucial to prevent severe outcomes.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-520020-28-00Protocol codeINMUNOCELL-CTMVEstimated enrolment32 patientsSponsorInstituto De Investigacion Marques De Valdecilla

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