Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

A Multicentre, Open-Label, Single Ascending Dose, Dose-Ranging, Phase I/IIa Study to Evaluate the Safety and Tolerability of an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (TX200-TR101) in Living Donor Renal Transplant Recipients

This study is looking into a new cell therapy, called TX200-TR101, designed specifically for people who have received a kidney transplant from a living donor. The main goal is to find out if this treatment is safe and well-tolerated by the body. We also want to see if it can successfully help stop the body from rejecting the new kidney. This work is a very early step in testing this treatment, as it's the first time it's being used in humans. It combines two early phases of research, meaning we're gently increasing the dose while carefully checking for any side effects and seeing how it helps prevent rejection.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Sangamo Therapeutics France

Enrolment target

Start

27 Jun 2024

Prophylaxis against renal transplant rejection

What is this study about?

When someone receives a kidney transplant, their body's immune system often sees the new kidney as 'foreign' and tries to attack it. This is called rejection. To prevent this, patients usually need to take powerful medicines for the rest of their lives. These medicines, while लाइफ-saving, can have side effects and weaken the immune system, making patients more prone to infections and other problems.

This study is testing a new and different approach. It uses a special type of cell therapy, called TX200-TR101, which is made from the patient's own cells. The idea is to 'teach' the patient's immune system to accept the new kidney without needing as many strong anti-rejection drugs. This could potentially lead to fewer side effects and a healthier life for transplant recipients.

The study is in its very early stages (Phase 1/2a), which means it's the first time this treatment is being given to people. Researchers will be carefully checking how safe the treatment is and if patients tolerate it well. They will also be looking closely to see if it helps prevent kidney rejection and how it affects the immune system over time.

Key takeaways

This study tests a new cell therapy (TX200-TR101) for kidney transplant patients.
The main goals are to check if the treatment is safe and helps prevent kidney rejection.
It's an early-stage study, meaning it's the first time humans are receiving this treatment.
Participation involves a single treatment and regular check-ups for about 84 weeks.
It aims to potentially reduce the need for lifelong anti-rejection medications.

Who may be eligible?

This study is designed for adults aged 18 and over who have recently received a kidney transplant from a living donor. Both men and women can take part.

To be considered, you would need to meet certain health criteria that the study doctors will explain fully. These criteria are in place to ensure the safety of participants and to make sure the study can gather clear and useful information about the new treatment.

It's important to discuss your full medical history with the study team, including any current medications or existing health conditions, to see if this study is suitable for you.

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 18 years old or older?
Have you recently received a kidney transplant from a living donor?
Are you able to attend regular hospital appointments for about 1.5 years?
Do you want to explore new ways to manage your kidney transplant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the TX200-TR101 cell therapy as a single infusion. After this, the study involves regular check-ups and assessments over a period of about 84 weeks (approximately a year and nine months). These appointments will allow the healthcare team to monitor your health closely.

During these visits, doctors will check for any side effects, take blood samples, and monitor your kidney function. There will also be a kidney biopsy early into the study to see how the treatment is working at a cellular level. Throughout the study, the team will keep a close eye on your existing anti-rejection medications and adjust them as needed, with the goal of reducing them if the new treatment is successful.

The total duration of your active involvement in the study will be around 84 weeks. After this, there might be long-term follow-up to check on your overall health and kidney function.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. A potential benefit could be that this new therapy helps your body accept your new kidney more effectively, possibly reducing the need for strong anti-rejection medications and their associated side effects. However, at this early stage, we don't know for sure if it will be effective. Potential risks include side effects from the study treatment itself, which will be monitored very closely, and the usual risks associated with kidney transplants and their necessary care. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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

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Unverified
Belgium
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Unverified
Netherlands

Common questions

What is TX200-TR101?

It's a new type of cell therapy made from your own cells, designed to help your immune system accept your new kidney.

Is this a new treatment?

Yes, this is the first time this specific treatment is being given to people, so it's a very early stage of research.

How long will I be in the study?

If you join, the study will involve regular check-ups for about 84 weeks, which is roughly a year and nine months.

Will I still need my usual anti-rejection medicines?

Yes, you will continue with your current medicines, but the study team will monitor and might adjust them over time if the new treatment is successful.

What if I change my mind about taking part?

You can withdraw from the study at any time, for any reason, and it won't affect the care you receive for your kidney transplant.