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Study on the Safety of ATreg Cells for Patients with Leukemia After Stem Cell Transplant to Reduce Graft vs Host Disease

Verified siteInvestigationalNo placebo
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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 studying the safety and tolerability of a new treatment for patients who have undergone a haematopoietic stem cell transplantation (HSCT). The treatment involves using a special type of immune cell called GP120-activated regulatory T cells (ATreg). These cells are designed to help reduce the incidence and severity of a condition known as acute Graft vs Host Disease (GvHD), which can occur after a stem cell transplant. The study is particularly relevant for patients with blood cancers such as leukaemia, who require a stem cell transplant as part of their treatment.

The purpose of the study is to assess how safe and tolerable the ATreg treatment is for patients. Participants in the study will receive the ATreg treatment through an infusion, which is a method of delivering medication directly into the bloodstream. The study will monitor participants for any serious side effects related to the treatment at various intervals, including 24 hours, 3 days, 7 days, and 14 days after receiving the ATreg infusion. Additionally, the study will observe the effects of the treatment on the incidence and severity of acute GvHD, as well as any potential infections or relapses of the underlying blood cancer.

Throughout the study, researchers will also track changes in blood components such as neutrophils, platelets, and haemoglobin to assess how well the transplanted cells are taking hold in the body. The study will continue to monitor participants for up to six months after the ATreg treatment to gather comprehensive data on the treatment's long-term effects, including any occurrences of GvHD, infections, or cancer relapse. This trial aims to provide valuable insights into the potential benefits and risks of using ATreg cells in patients who have recently undergone a stem cell transplant.

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

    Participation begins after meeting specific criteria, including being an adult with a hematologic condition requiring a stem cell transplant.

    A healthy donor must be available, and the transplant must be planned.

  2. Step 2

    Treatment preparation

    The treatment involves the use of allogeneic cd4+ and cd25+ t lymphocytes, which are special cells prepared outside the body.

    These cells are activated with a substance called gp120 before being used in the treatment.

  3. Step 3

    Treatment administration

    The activated cells are given as a solution for infusion, which means they are delivered directly into the bloodstream.

    This step is crucial for assessing the safety and tolerability of the treatment.

  4. Step 4

    Monitoring and follow-up

    After the infusion, monitoring occurs at several intervals: within 24 hours, 3 days, 7 days, and 14 days.

    Further assessments are conducted at days 28, 56, and 90, and at 6 months after the treatment.

  5. Step 5

    Evaluation of outcomes

    The study evaluates the type, incidence, and severity of any serious side effects related to the treatment.

    Other outcomes include the incidence of infections, relapse of the disease, and overall survival without relapse.

Who can join the trial?

7 criteria

  • Must be an adult aged 18 years or older, any gender.
  • Must be willing and able to provide written permission to participate, known as informed consent.
  • Must have a healthy third-party donor available.
  • Must meet all requirements for a hematopoietic stem cell transplant (HSCT), which is a procedure to replace damaged or diseased bone marrow, and have a transplant planned. The source can be either peripheral blood or bone marrow, with any HLA status (a type of tissue compatibility) and any blood group.
  • Must have a donor who is a good match for HLA (10 out of 10 or 9 out of 10 matches).
  • Must have a blood-related cancer, such as acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), acute lymphoblastic leukemia (ALL), multiple myeloma (MM), myeloproliferative neoplasms (MPN), or lymphoma (including B-cell non-Hodgkin lymphoma (B-NHL) and Hodgkin lymphoma), that requires a transplant.
  • Must have a life expectancy of more than 6 weeks.

Who cannot join the trial?

8 criteria

  • Patients who have any other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent major surgery.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of allergic reactions to similar treatments.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures or instructions.
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Investigated drugs

GP120-activated Regulatory T cells (ATreg) are a type of therapy being studied for their potential to reduce the incidence and severity of acute Graft vs Host Disease (GvHD) after a patient undergoes a haematopoietic stem cell transplantation (HSCT). This therapy involves using a specific type of immune cell, known as regulatory T cells, which are activated by a protein called GP120. The goal is to help control the immune response and prevent the body from attacking the transplanted cells, which can lead to GvHD. The study is focused on understanding how safe and tolerable this treatment is for patients.

What is already known about the treatment

GP120-activated Regulatory T cells (ATreg) – This medication is administered through infusion, typically following a hematopoietic stem cell transplantation. It is currently being studied in clinical trials to evaluate its safety and tolerability, particularly in reducing the incidence and severity of acute graft versus host disease (GvHD) in patients with leukemia. The main therapeutic indication is to prevent complications after stem cell transplants. At the molecular level, ATreg works by modulating the immune response, potentially reducing harmful immune reactions. It is classified under immunomodulatory therapies, focusing on enhancing the body's regulatory T cell function to maintain immune balance.

Investigated diseases

Leukemia – Leukemia is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of abnormal white blood cells. These abnormal cells crowd out normal blood cells, leading to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The disease can progress rapidly or slowly, depending on the type, which includes acute and chronic forms. In acute leukemia, the disease progresses quickly and requires immediate treatment, while chronic leukemia progresses more slowly and may not show symptoms for years. The exact cause of leukemia is not known, but it involves genetic and environmental factors. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-516599-14-00Protocol codeATreg-001Estimated enrolment10 patientsSponsorActiTrexx GmbH

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