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Engineered immune cells aim to trick the body into accepting a new kidney

NCT ID NCT04817774

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This trial tests a new cell therapy called TX200-TR101 in people who receive a kidney from a living donor. The therapy is made from the patient's own immune cells, which are genetically modified to help the body accept the donated kidney instead of rejecting it. The study focuses on safety and how well the therapy works, and involves a small group of participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TX200-TR101 (CAR-Tregs)
What this could lead to
If successful, this approach could reduce or eliminate the need for lifelong immunosuppressive drugs after kidney transplant, improving quality of life.
What could go wrong
This is an early-phase trial with a small number of participants. The therapy may not work as hoped, and there are risks from the cell infusion and genetic modification.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

26 people

The number who actually took part.

Started

Mar 2021

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Written informed consent. * Male or female aged 18 - 70 years. * Diagnosis of End Stage Renal Disease and waiting for a new kidney from an identified live donor. * Subjects who will be single organ recipients (kidney). * Able and willing to use contraception. Exclusion Criteria: * HLA identical to the donor. * Subjects with prior organ transplant. * Known hypersensitivity to study medication ingredients, protocol defined immunosuppressive medications, or a significant allergic reaction to any drug. * Positive serology for human immunodeficiency virus (HIV) or syphilis, active or occult hepatitis B virus (HBV), active hepatitis C virus (HCV) infection, or other clinically active local or systemic infection. * Subjects who are Epstein-Barr Virus (EBV) seronegative. * Positive flow cytometric crossmatch using donor lymphocytes and recipient serum. * Subjects with panel-reactive antibody (PRA) \>20% within 6 months prior to enrolment. * Subjects with current or recent donor-specific antibodies. * Use of any experimental medicinal product within 3 months. * Current use of systemic immunosuppressive agents * Significant unstable or poorly controlled acute or chronic diseases (except ESRD), limited life expectancy, clinically relevant central nervous system pathology, history of drug/alcohol abuse or psychiatric disorder or other condition that is not compatible with adequate study follow-up, history of malignancy in the past 5 years and any other reason that, in the opinion of the Site Investigator or Medical Monitor, would render the subject unsuitable for participation in the study. * Subjects with abnormal laboratory values in the following parameters: * Haemoglobin * Platelets * White blood cells * Aspartate transaminase (AST) and or alanine transaminase (ALT) * Total bilirubin

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Erasmus MC, University Medical Center

    Rotterdam, 3015 CN, Netherlands

  • Leiden University Medical Centre

    Leiden, 2333 ZA, Netherlands

  • Oxford University Hospitals NHS Foundation Trust,

    Oxford, United Kingdom

  • University Hospitals Leuven

    Leuven, Belgium

  • University Medical Center Groningen

    Groningen, Netherlands

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