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Safety Study of Regulatory T Cells (Treg02) and Tacrolimus Discontinuation in Adult Liver Transplant Recipients

Verified siteRegistered drugNo 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 focuses on patients who have undergone liver transplantation and are currently taking tacrolimus, a medication that prevents organ rejection. The study evaluates a new treatment called Treg02, which consists of specially processed immune cells (regulatory T cells) that are taken from the patient's own body, grown in a laboratory, and then given back to the patient through an intravenous injection.

The main purpose of this study is to determine if Treg02 treatment is safe and well-tolerated in liver transplant patients who are taking tacrolimus alone, and whether it can help patients eventually stop taking their anti-rejection medication. During the study, patients will receive paracetamol and dimetindene as supportive medications. The treatment involves taking blood from the patient, processing it to isolate and multiply specific immune cells in a laboratory, and then giving these cells back to the patient through an injection into a vein.

The study will monitor patients for any side effects from the treatment, particularly focusing on reactions to the cell infusion, infections, and signs of organ rejection. Patients will undergo regular check-ups, including blood tests and tissue samples from the transplanted liver, to ensure their safety and evaluate how well the treatment is working. The total duration of patient monitoring in the study will be approximately 14 months after receiving the cell treatment.

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

    Initial evaluation

    Your liver function will be evaluated through clinical tests to ensure stability

    A liver biopsy will be performed to check for any abnormalities

    Basic blood tests will be conducted to verify hemoglobin, platelet, and white blood cell counts

  2. Step 2

    Current medication assessment

    Confirmation that you have been on tacrolimus alone for at least 6 months

    Verification that your tacrolimus blood levels are stable at 5 ng/ml

  3. Step 3

    Treatment preparation

    Your immune system cells (regulatory T cells) will be collected

    These cells will be processed in a laboratory to increase their numbers

    The prepared cells will be called Treg02

  4. Step 4

    Cell treatment administration

    Treg02 cells will be given through an intravenous injection

    You will be monitored for any immediate reactions during and after the infusion

  5. Step 5

    Monitoring period

    Regular check-ups will occur over 14 months

    Blood tests will be performed to monitor liver function

    Additional liver biopsies may be needed to check for signs of rejection

    You will complete quality of life questionnaires

    Monitoring for infections, especially viral infections, will be conducted

    Your tacrolimus medication will be gradually reduced

  6. Step 6

    Final assessment

    Final evaluation of liver function

    Assessment of overall health status

    Review of any side effects or complications

    Completion of final quality of life questionnaire

Who can join the trial?

11 criteria

  • Must be an adult aged 18 or older who has received a single liver transplant
  • Must have had the liver transplant between 2 to 5 years ago
  • Must be able and willing to provide signed consent to participate in the study
  • Must test negative for SARS-CoV-2 (the virus that causes COVID-19)
  • Must have normal results from the most recent liver biopsy (tissue sample examination) performed around 1 year after transplant or at study entry
  • Must have stable liver function shown by specific blood test results: - Direct bilirubin less than 1 mg/dl - Total bilirubin less than 2.2 mg/dl - Albumin greater than 3 g/l - ALT less than 62 IU/l
  • Must have acceptable levels of inflammation and tissue scarring in the liver
  • Must be stable for at least 6 months on tacrolimus (an anti-rejection medication) alone
  • Must not have any autoimmune liver diseases
  • Must have acceptable blood test results: - Hemoglobin level of 7.0 g/dl or higher - Platelet count of 80,000 or higher - White blood cell count of 3,000 or higher
  • Must be willing and able to follow all study requirements

Who cannot join the trial?

15 criteria

  • Age under 18 or over 65 years old
  • Having an active infection (an illness caused by harmful organisms like bacteria or viruses)
  • History of cancer in the past 5 years
  • Presence of autoimmune diseases (conditions where the body's immune system attacks its own tissues)
  • Pregnant or breastfeeding women
  • Having received any other organ transplant besides liver
  • Current participation in other clinical trials
  • Severe kidney problems
  • Uncontrolled diabetes (high blood sugar levels)
  • History of severe allergic reactions to medications
  • Significant heart or lung disease
  • Active substance abuse or alcohol dependency
  • Mental conditions that could affect ability to follow study requirements
  • Taking medications that could interfere with the study treatment
  • Signs of liver transplant rejection in the past 6 months
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Investigated drugs

  • Treg02

    (autologous polyclonal regulatory T cells) is a cell therapy made from the patient's own immune cells. These cells are collected from the patient's blood, grown in a laboratory to increase their numbers, and then given back to the patient. This therapy aims to help regulate the immune system in liver transplant patients.

  • Tacrolimus

    is a medication that suppresses the immune system to prevent organ rejection in transplant patients. It is commonly used after liver transplantation to prevent the body from attacking the transplanted organ. In this trial, doctors are studying if Treg02 therapy can help patients safely stop taking tacrolimus.

What is already known about the treatment

  • Tacrolimus

    A potent immunosuppressive medication administered orally or intravenously, primarily used to prevent organ rejection in transplant recipients, particularly in liver transplantation. This medication works by inhibiting T-lymphocyte activation and suppressing the immune system's response, belonging to the calcineurin inhibitor class of drugs. Tacrolimus is currently a standard-of-care medication in transplant medicine, with extensive documentation in medical literature supporting its effectiveness in preventing organ rejection while requiring careful monitoring of blood levels to maintain the optimal therapeutic range.

  • Regulatory T cells (Tregs)

    An innovative cellular therapy administered through infusion, consisting of the patient's own immune cells that have been specially expanded and activated in laboratory conditions. These cells are being investigated as a potential treatment to help liver transplant patients reduce or eliminate their dependence on conventional immunosuppressive medications like tacrolimus. Regulatory T cells work naturally in the body to maintain immune tolerance and prevent autoimmune responses, and their therapeutic application represents a cutting-edge approach in transplant medicine that aims to achieve a more targeted form of immunosuppression.

Investigated diseases

Solid Organ Transplantation (Liver) - A medical condition where a damaged or failing liver is surgically replaced with a healthy liver from a donor. The recipient's immune system naturally recognizes the new organ as foreign and attempts to reject it. After transplantation, the body's immune system begins mounting a response against the new liver tissue. This process can lead to complications if the immune response is not properly controlled. The immune system's reaction to the transplanted liver can vary in intensity and timing. The body continues to maintain an immune response to the transplanted organ over time. Note: I've provided a single disease description based on the medical condition mentioned in the source data. The description focuses on the condition and its progression, avoiding treatment methods, diagnostics, and prognosis, as requested.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-508261-32-00Protocol codeLiveTregEstimated enrolment27 patientsSponsorCharite Universitaetsmedizin Berlin KöR

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