Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Safety & Tolerability Study of Chimeric Antigen Receptor T-Reg Cell Therapy in Living Donor Renal Transplant Recipients

This research study is testing a new treatment, TX200-TR101, for people who are receiving a kidney transplant from a living donor. The main goal is to find out if this treatment is safe and tolerable, and how well it helps the donated kidney function. TX200-TR101 is made from a patient's own immune cells, which are specially changed in a lab to help their body accept the new kidney and stop their immune system from rejecting it. This is an early-stage study, meaning it's one of the first times this treatment is being used in people. The study will involve transplant recipients who get the treatment, other transplant recipients who don't get the treatment (for comparison), and the kidney donors.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Sangamo Therapeutics

Enrolment target

Start

17 Mar 2021

Estimated completion

29 Oct 2025

Kidney Transplant Rejection End Stage Renal Disease

What is this study about?

When someone receives a kidney transplant, their body's immune system naturally tries to fight off what it sees as 'foreign' – the new kidney. This is called rejection. To prevent rejection, transplant patients usually need to take powerful medicines for the rest of their lives. While these medicines save lives, they can also have serious side effects like making patients more prone to infections or other health problems. This study is exploring a new way to help the body accept a donated kidney, aiming to potentially reduce the need for strong anti-rejection medications in the future.

The new treatment, called TX200-TR101, is quite clever. Researchers take some of the patient's own immune cells and modify them in a lab. These specially trained cells are then put back into the patient's body. The idea is that these modified cells will help 'teach' the immune system to recognise the donated kidney as part of the body, rather than attacking it. Because these are the patient's own cells, it's hoped they will be safer and might lead to fewer side effects compared to traditional anti-rejection drugs.

The study involves different groups of people. Some kidney transplant patients will receive TX200-TR101, while others will be in a comparison group and won't get the treatment – but will still be monitored. The study also includes the people who generously donate their kidney. This approach helps researchers understand if the new treatment is making a real difference. If successful, this kind of treatment could offer a brand new option for people needing kidney transplants, making life with a donated kidney healthier and simpler.

Key takeaways

This study is testing a new treatment to help kidney transplant patients.
The treatment uses your own immune cells to prevent kidney rejection.
It's an early-stage study focusing on safety and how well it works.
It could potentially reduce the need for standard anti-rejection drugs.
Participation involves close monitoring before and after your transplant.

Who may be eligible?

To join this study, you need to be between 18 and 70 years old. You must have advanced kidney disease and be waiting to receive a kidney transplant from a living donor. Importantly, you should only be receiving a kidney, not any other organs, in this transplant.

There are also some reasons why you might not be able to join. For instance, if you've had an organ transplant before, or if you have certain infections like HIV or active Hepatitis B or C. People who have had some types of cancer in the last five years, or have other serious uncontrolled health conditions, may also not be suitable. The doctors will also check your blood test results to make sure they are within a healthy range for the study. If you have had any other experimental treatments recently, you might also be excluded.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Are you waiting for a kidney transplant from a living donor?
Will you only be receiving a kidney, not other organs?
Do you have a diagnosis of end-stage kidney disease?
Have you not had an organ transplant before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step is to read and sign a consent form, which explains everything in detail. You will have regular visits to the hospital for checks and tests, especially in the period just before and after your transplant. During these visits, doctors will closely monitor your health, look at how your new kidney is working, and check for any side effects from the treatment.

Those receiving TX200-TR101 will have their own immune cells collected, which will then be prepared in a lab. After your transplant, you will receive the TX200-TR101 treatment. The study involves ongoing follow-up for a period of time to make sure the treatment is safe and effective in helping your body accept the new kidney. The exact number and timing of visits will be explained by the study team, but generally, there will be more frequent visits initially, becoming less often over time.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The main aim of this study is to see if TX200-TR101 is a safe and effective way to help your body accept a donated kidney. If successful, this new treatment might reduce the need for lifelong anti-rejection medications and their side effects in the future. However, because this is an early-stage study, we don't know all the possible risks yet. There could be side effects from the new treatment itself, or from the procedures involved in collecting and giving your cells. The study team will explain all the known risks to you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals Leuven
Verified postcode
Leuven, Belgium
University Medical Center Groningen
Verified postcode
Groningen, Netherlands
Leiden University Medical Centre
Verified postcode
Leiden, Netherlands
Erasmus MC, University Medical Center
Verified postcode
Rotterdam, Netherlands
Oxford University Hospitals NHS Foundation Trust,
Verified postcode
Oxford, United Kingdom

Common questions

What is TX200-TR101?

It's a new treatment made from your own immune cells, specially designed to help your body accept a new kidney and prevent rejection.

Will I still need to take other anti-rejection medicines?

This study aims to explore if traditional anti-rejection medicines can be reduced in the future. During the study, you might still need some, but the research could lead to changes down the line.

Who can be a living kidney donor for this study?

The study involves people who are already identified as living kidney donors for the recipient. Their specific role in the study will be explained.

What does 'Phase 1/2' mean for a study?

It means this is an early-stage study. Phase 1 focuses heavily on safety, while Phase 2 starts to look more at how well the treatment works and at different dosages.

How long will I be involved in the study?

The study involves follow-up over a period of time after your transplant. The exact duration and number of visits will be explained by the study team.