Engineered immune cells aim to trick the body into accepting a new kidney
NCT ID NCT04817774
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 Hide 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
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Oxford University Hospitals NHS Foundation Trust,
Oxford, United Kingdom
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University Hospitals Leuven
Leuven, Belgium
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University Medical Center Groningen
Groningen, Netherlands
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