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Study on the Safety of Eight Treg and Drug Combination for Patients with Chronic Kidney Failure Undergoing Transplant from a Living Donor

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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 treatments for people with chronic kidney disease who need a kidney transplant. The main treatment being tested is called Eight Treg, which is a type of cell therapy involving special immune cells known as CD8+ regulatory T cells. These cells are taken from the patient, grown in a lab, and then given back to the patient through an infusion. The study also involves the use of standard medications that help prevent the body from rejecting the new kidney. These medications include corticosteroids, tacrolimus, and mycophenolic acid.

The purpose of the study is to evaluate the safety of the Eight Treg treatment when used alongside these standard medications. Participants will receive the Eight Treg infusion the day before their kidney transplant. The study will monitor participants for up to three months after the transplant to check for any side effects or complications. The study will also look at how the treatment affects the immune system and the new kidney over time.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the function of their new kidney. These tests will include blood tests and possibly biopsies of the kidney to ensure everything is working as expected. The study aims to provide valuable information on how well the Eight Treg treatment works in helping kidney transplant patients and how safe it is to use with other medications.

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

    Initiation of treatment

    The trial begins with the administration of the experimental drug Eight Treg through an intravenous infusion. This occurs the day before the kidney transplant procedure.

    The purpose of this step is to evaluate the safety of the drug in combination with standard medications used to prevent organ rejection.

  2. Step 2

    Kidney transplant procedure

    The kidney transplant is performed using a kidney from a living donor. This is a critical step in the treatment of chronic renal failure.

  3. Step 3

    Post-transplant medication regimen

    After the transplant, a combination of medications is administered to prevent organ rejection and manage the immune response.

    These medications include corticosteroids such as methylprednisolone hydrogen succinate (500 mg, intravenous bolus use) and prednisone (20 mg, oral use), tacrolimus (5 mg/ml, intravenous use), and mycophenolic acid (180 mg, oral use).

    The medication regimen is maintained for up to three months post-transplant.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor the patient's health and the function of the transplanted kidney.

    Blood tests and other assessments are conducted to track the immune response and detect any potential complications.

    The occurrence of any dose-limiting toxicity is monitored up to three months post-transplant.

  5. Step 5

    Extended monitoring

    Further monitoring is conducted up to six and twelve months post-transplant to assess long-term outcomes.

    This includes analysis of graft biopsies, monitoring of infections, and evaluation of the total immunosuppressive burden.

Who can join the trial?

10 criteria

  • Man or woman with chronic renal failure needing a kidney transplant and approved to receive a first kidney from a living donor.
  • Must be part of or benefit from a social security scheme.
  • Must speak and understand French.
  • Weight should be between 50 and 100 kg.
  • Must have up-to-date vaccination against SARS Cov2 (the virus causing COVID-19) according to current health guidelines, with the last vaccine dose given at least 1 to 6 months before the first visit.
  • Must have negative results on specific tests called microlymphocytotoxicity (LCT) and flow cytometry crossmatches, which are tests to check compatibility with the donor, regardless of HLA compatibility (a genetic matching test).
  • Must provide signed and dated written informed consent, which means agreeing to participate after understanding the study details.
  • Must be at least 18 years old on the day the consent is signed.
  • Must be able to start the IS regimen (immunosuppressive treatment) at the time specified in the study plan.
  • Women of childbearing age should use an effective method of birth control, and male participants should use contraception to prevent pregnancy during the study.

Who cannot join the trial?

5 criteria

  • Patients who do not have chronic renal failure that requires a kidney transplant cannot participate. Chronic renal failure means the kidneys are not working well for a long time, and a transplant is needed.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are not receiving a kidney from a living donor cannot participate. A living donor is someone who is alive and donates a kidney.
  • Patients who are not able to receive the experimental drug "Eight Treg" or the usual drugs used after a transplant cannot participate. These usual drugs include corticosteroids (medicines that reduce inflammation), tacrolimus (a medicine that helps prevent organ rejection), and MPA (a medicine that also helps prevent organ rejection).
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes people who might need special protection or care.
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Investigated drugs

  • Eight Treg

    is an experimental therapy involving the infusion of specially prepared immune cells called regulatory CD8+ T cells. These cells are taken from the patient, expanded outside the body, and then infused back into the patient. The goal is to help the body accept a new kidney from a living donor by regulating the immune response.

  • Corticosteroids

    are medications used to reduce inflammation and suppress the immune system. In this trial, they are part of the standard treatment to help prevent the body from rejecting the transplanted kidney.

  • Tacrolimus

    is an immunosuppressive drug that helps prevent organ rejection after a transplant. It works by decreasing the activity of the immune system to stop it from attacking the new kidney.

  • MPA

    (Mycophenolic Acid) is another immunosuppressive medication used to prevent the body from rejecting a transplanted organ. It works by inhibiting the proliferation of cells that can attack the new kidney.

What is already known about the treatment

Eight Treg – This medication is administered through an intravenous infusion, typically given the day before a kidney transplant. It is currently in the experimental phase, being studied for its safety and effectiveness in medical literature. The main therapeutic indication is to support kidney transplant patients by potentially reducing the risk of organ rejection. Eight Treg works by using specially prepared immune cells, known as regulatory CD8+ T cells, to help control the body's immune response. It falls under the pharmacological classification of immunotherapy, specifically targeting immune regulation.

Investigated diseases

Chronic Kidney Disease – This condition involves the gradual loss of kidney function over time. The kidneys become less effective at filtering waste and excess fluids from the blood, which can lead to a buildup of harmful substances in the body. As the disease progresses, symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns may occur. In advanced stages, the kidneys may fail completely, necessitating dialysis or a kidney transplant. Chronic kidney disease can be caused by various factors, including diabetes, high blood pressure, and certain genetic disorders. Managing the condition involves monitoring kidney function and addressing underlying causes to slow progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-513771-40-01Protocol codeRC24_0033Estimated enrolment9 patientsSponsorCentre Hospitalier Universitaire De Nantes

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).