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Eight Treg

A groundbreaking clinical trial is underway to assess the safety and potential of “Eight Treg,” an innovative cell therapy for kidney transplant patients. This study aims to reduce dependence on traditional immunosuppressive drugs by using the patient’s own regulatory T cells to promote graft tolerance. The trial represents a significant step forward in transplant medicine, offering hope for improved long-term outcomes and reduced side effects for kidney transplant recipients.

Table of Contents

What is EIGHT TREG?

EIGHT TREG is an experimental drug being studied for use in kidney transplant patients[1]. It’s a type of treatment called cell therapy, which means it uses living cells as a medicine. Specifically, EIGHT TREG is made from a patient’s own immune cells, called CD8+ regulatory T cells (also known as CD8+ Tregs)[1].

How Does It Work?

Here’s how EIGHT TREG is prepared and given to patients:

  1. The patient’s own CD8+ Tregs are collected from their blood.
  2. These cells are grown and multiplied in a laboratory for 21 days[1].
  3. The expanded cells are then given back to the patient through an intravenous (IV) infusion the day before their kidney transplant surgery[1].

The goal is for these regulatory T cells to help control the immune system’s response to the new kidney, potentially reducing the risk of rejection.

Why Is It Being Developed?

EIGHT TREG is being developed to address some of the challenges faced by kidney transplant patients[1]:

  • Long-term graft survival: Current anti-rejection drugs (immunosuppressants) don’t always prevent chronic problems with the transplanted kidney.
  • Side effects of immunosuppressants: These drugs can increase the risk of infections and cancers, and may have other negative effects on the body.
  • Graft tolerance: Researchers hope that treatments like EIGHT TREG might help the body accept the new kidney with less need for long-term immunosuppressant drugs.

Current Research

EIGHT TREG is currently being studied in a Phase I clinical trial[1]. This is an early stage of research focused on testing the safety of the treatment. Key points about the study include:

  • It involves 9 patients receiving kidney transplants from living donors.
  • Different doses of EIGHT TREG will be tested to find the safest and most effective amount.
  • This is the first time expanded CD8+ Tregs will be given to humans.
  • The study is being conducted at Nantes University Hospital in France.

Potential Benefits

While it’s too early to know for sure, researchers hope that EIGHT TREG might offer several benefits for kidney transplant patients[1]:

  • Reduced inflammation in the transplanted kidney
  • Lower total immunosuppressive burden, meaning patients might need less anti-rejection medication
  • Fewer infections in the year after transplant
  • Potentially improved long-term survival of the transplanted kidney

Safety Considerations

The main goal of the current study is to evaluate the safety of EIGHT TREG[1]. Researchers will be closely monitoring patients for:

  • Treatment-related side effects, especially in the first 3 months after transplant
  • Any serious side effects (called “dose-limiting toxicities”) that might require stopping or adjusting the treatment

It’s important to note that similar cell therapies using other types of regulatory cells have been tested in transplant patients without causing significant side effects[1].

Future Prospects

This early study of EIGHT TREG is an important first step in exploring the potential of CD8+ Treg therapy for transplant patients[1]. If the results are promising, it could lead to larger studies to further test the effectiveness of this approach. The long-term hope is that treatments like EIGHT TREG might help reduce reliance on traditional immunosuppressant drugs and improve outcomes for kidney transplant recipients.

Aspect Details
Study Type Phase I clinical trial
Experimental Drug Eight Treg (autologous CD8+ regulatory T cells)
Target Population Living donor kidney transplant recipients
Administration Peripheral IV infusion one day before transplant
Primary Outcomes Safety assessment, adverse events, dose-limiting toxicity
Secondary Outcomes Graft inflammation, immunosuppressive burden, infection rates, immune response evaluation
Potential Benefits Reduced dependence on conventional immunosuppressants, improved graft tolerance
Significance First human trial of expanded CD8+ Tregs in transplantation

FAQ

  • What is Eight Treg? Eight Treg is an experimental cell therapy product containing CD8+ regulatory T lymphocytes (Tregs) that are expanded from the patient's own cells. It is designed to help prevent rejection in kidney transplant recipients.
  • How is Eight Treg administered? Eight Treg is given to patients through a peripheral IV infusion the day before their kidney transplant surgery, in addition to the standard immunosuppressive medications.
  • What are the potential benefits of Eight Treg? The goal of Eight Treg is to induce graft tolerance, potentially reducing the need for long-term immunosuppressive drugs and their associated side effects, such as increased risk of infections and malignancies.
  • Who is eligible for this clinical trial? This phase I trial is designed for recipients of kidney transplants from living donors. The study aims to include 9 participants to assess the safety of increasing doses of Eight Treg.
  • What outcomes are being measured in this trial? The primary outcomes focus on safety, including the number of treatment-related adverse events and dose-limiting toxicities. Secondary outcomes include graft inflammation, immunosuppressive burden, infection rates, and biological evaluation of immune responses.

Ongoing Clinical Trials on Eight Treg

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

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Regulatory T cells (Tregs): A type of immune cell that helps control the immune system's response, potentially preventing rejection of transplanted organs.
  • CD8+ T cells: A specific type of immune cell that can have regulatory functions and is the focus of the Eight Treg therapy.
  • Immunosuppressive (IS) drugs: Medications that reduce the activity of the immune system, used to prevent rejection in organ transplant recipients.
  • Graft tolerance: A state where the immune system accepts the transplanted organ without the need for ongoing immunosuppression.
  • Ex vivo expansion: The process of growing and multiplying cells outside the body in a laboratory setting.
  • Autologous: Using cells or tissues from the same individual, in this case, the patient's own regulatory T cells.
  • Phase I clinical trial: An initial study in humans to evaluate the safety and dosing of a new treatment.
  • Dose escalation: A method in clinical trials where the dose of a treatment is gradually increased to find the optimal safe dose.
  • Adverse event (AE): Any unfavorable or unintended sign, symptom, or disease associated with the use of a medical treatment.
  • CTCAE: Common Terminology Criteria for Adverse Events, a standardized method for classifying the severity of side effects in cancer therapy and other medical treatments.

References

  1. https://clinicaltrials.gov/study/NCT06777719