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Safety Study of Regulatory T Cells (Treg02) in Patients After Kidney Transplant

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What is this trial about?

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

This clinical trial investigates the use of regulatory T cells (Treg02) as an additional therapy in people receiving kidney transplants. The study aims to determine if giving patients their own modified immune cells is safe and can help prevent transplant rejection while potentially reducing the need for other immunosuppressive medications. The main treatment being tested is Treg02, which is given by injection, along with standard anti-rejection medications including tacrolimus, mycophenolate mofetil, and methylprednisolone.

During the study, participants who have received a kidney transplant will be given their own immune cells that have been specially processed in a laboratory. These cells, called regulatory T cells, are part of the body's natural system for controlling immune responses. The researchers will monitor the safety of this treatment and how well it works with regular check-ups and tests over approximately 60 weeks.

Other medications that may be used during the study include sulfamethoxazole and trimethoprim to prevent infections, valganciclovir for viral infections, and medications like paracetamol and dimetindene to manage side effects. The study will track any complications, infections, or rejection episodes that occur, as well as how well the transplanted kidney is working.

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

    Initial medication before transplant

    You will receive methylprednisolone tablets as part of the initial treatment.

    A medication called Thymoglobuline will be administered through infusion to help prevent organ rejection.

  2. Step 2

    Transplant procedure and Treg02 administration

    After receiving the kidney transplant, you will receive an injection of Treg02, which contains specially prepared immune cells.

    During this period, you will be monitored for any immediate reactions to the treatment.

  3. Step 3

    Post-transplant medications

    You will receive tacrolimus in the form of tablets or capsules to prevent organ rejection.

    Mycophenolate mofetil tablets will be administered to help suppress the immune system.

    Valganciclovir tablets will be given to prevent viral infections.

    Cotrim tablets will be provided as protection against certain types of infections.

    Paracetamol tablets may be given if needed for pain management.

  4. Step 4

    Monitoring period

    Regular monitoring will continue for 60 weeks after transplantation.

    Kidney biopsies will be performed to check for signs of rejection.

    Blood tests will be conducted to monitor kidney function and medication levels.

    Your overall health status will be regularly assessed.

  5. Step 5

    Long-term follow-up

    The total duration of the study extends until June 2027.

    Regular check-ups will continue to monitor the transplanted kidney's function.

    Medication doses may be adjusted based on your response to treatment.

Who can join the trial?

7 criteria

  • Must be between 18 and 70 years old
  • Must have severe kidney disease with a kidney function (GFR) less than 15 ml/min and be approved for transplantation
  • Must be willing and able to participate in the trial
  • Must provide written informed consent (for those unable to read/write, verbal consent with a witness signature is acceptable)
  • Must have minimum blood test values: - Hemoglobin level of at least 7.0 g/dl - Blood platelet count of at least 80,000 per microliter - White blood cell count of at least 3,000 per microliter
  • Must have a Karnofsky performance score between 40 and 90 (this measures the patient's ability to perform daily activities)
  • The kidney donor must be: - At least 18 years old - If over 50 years old, they cannot have more than 2 of these conditions: - High blood pressure - High creatinine levels (above 1.5 mg/dl) - Expected kidney storage time before transplant longer than 24 hours

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Active or chronic infections including but not limited to:
    • Hepatitis B (liver infection)
    • Hepatitis C (liver infection)
    • HIV (human immunodeficiency virus)
    • Tuberculosis (bacterial infection affecting lungs)
    • Previous organ transplants other than current kidney transplant
    • Current pregnancy or planning to become pregnant during the study
    • Active cancer or history of cancer in the past 5 years
    • Severe heart, lung, or liver disease
    • Uncontrolled diabetes (high blood sugar levels)
    • Active autoimmune diseases (conditions where immune system attacks own body)
    • Mental conditions that could affect ability to follow study requirements
    • Participation in other clinical trials within past 30 days
    • Known allergies to study medications
    • Drug or alcohol abuse within the past year
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Investigated drugs

  • Regulatory T cells (Tregs)

    This is a cell therapy that uses the patient's own immune cells, specifically T regulatory cells (Tregs). These cells are taken from the patient, expanded (multiplied) in a laboratory, and then given back to the patient. Tregs are natural cells in our body that help control immune responses and prevent the immune system from attacking healthy tissues. In kidney transplant patients, these cells may help prevent rejection of the transplanted organ and potentially reduce the need for other immunosuppressive medications.

  • Standard Immunosuppressive Therapy

    This refers to the conventional medications that transplant patients receive to prevent organ rejection. The study aims to see if using Treg therapy might allow doctors to reduce or eliminate the need for these standard anti-rejection medications, which can have significant side effects when used long-term.

What is already known about the treatment

Regulatory T cells (Tregs) - A specialized cellular therapy administered intravenously that consists of the patient's own immune cells (T-regulatory cells) which have been collected, expanded in the laboratory, and then reinfused. This experimental treatment is currently being investigated in clinical trials for kidney transplant recipients to potentially reduce the need for conventional immunosuppressive medications. The therapy works by enhancing the body's natural immune regulatory mechanisms, helping to prevent organ rejection while maintaining the ability to fight infections. These cells function by suppressing excessive immune responses and promoting tolerance to the transplanted kidney, representing a promising advancement in transplant medicine that could potentially reduce the long-term complications associated with traditional anti-rejection medications.

Investigated diseases

  • End-Stage Renal Disease

    A condition where the kidneys permanently lose their ability to filter waste from the blood, leading to the need for kidney transplantation. The disease develops gradually as kidney function deteriorates over time. It causes buildup of waste products and excess fluid in the body, affecting multiple organ systems. The condition leads to various complications including anemia, bone disease, and high blood pressure.

  • Kidney Transplant Rejection

    A process where the recipient's immune system recognizes the transplanted kidney as foreign and attempts to destroy it. The rejection can occur at different times after transplantation and varies in severity. The immune system produces antibodies and activates immune cells that attack the donated organ. Rejection can develop suddenly or gradually, affecting the function of the transplanted kidney.

  • Chronic Kidney Rejection

    A slow, progressive deterioration of the transplanted kidney that occurs over months or years. The condition involves gradual scarring and damage to the kidney tissue. It results in declining kidney function and changes in the organ's structure. The process involves both immune and non-immune mechanisms affecting the transplanted organ.

  • Graft Dysfunction

    A condition where the transplanted kidney shows signs of poor or declining function. It can develop gradually or suddenly after transplantation. The condition may involve inflammation and damage to the kidney's filtering units. Changes in kidney structure and function can be observed through various clinical signs.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514398-23-00Estimated enrolment27 patientsSponsorCharite Universitaetsmedizin Berlin KöR

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