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Kidney Transplant RejectionPhase 1/2STEADFASTNCT04817774

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

A Phase 1/2 study testing TX200-TR101 in people with Kidney Transplant Rejection and End Stage Renal Disease, run by Sangamo Therapeutics at 5 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and tolerability of TX200-TR101 and its effects on the donated kidney in living donor kidney transplant recipients. TX200-TR101 is a product made from a kidney transplant recipient's own immune cells, which are genetically modified and designed to help the transplant… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
TX200-TR101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
5 sitesin 3 countries
Study dates
17 Mar 2021to 16 Oct 2025
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

Netherlands3 sites

  • University Medical Center Groningen

    Groningen

  • Leiden University Medical Centre

    Leiden, 2333 ZA

  • Erasmus MC, University Medical Center

    Rotterdam, 3015 CN

Other trials in Netherlands

Belgium1 site

  • University Hospitals Leuven

    Leuven

Other trials in Belgium

United Kingdom1 site

  • Oxford University Hospitals NHS Foundation Trust,

    Oxford

Other trials in United Kingdom

About this study

Official title: Multicentre Open-Label Single Ascending Dose Dose-Ranging Phase I/IIa Study to Evaluate Safety and Tolerability of an Autologous Antigen-Specific Chimeric Antigen Receptor TRegulatory Cell Therapy in Living Donor Renal Transplant Recipients

The purpose of this study is to evaluate the safety and tolerability of TX200-TR101 and its effects on the donated kidney in living donor kidney transplant recipients. TX200-TR101 is a product made from a kidney transplant recipient's own immune cells, which are genetically modified and designed to help the transplant recipient's body accept their donated kidney and prevent their immune system from rejecting it.

Read the detailed description

This is a multicentre, first-in-human, open-label, single ascending dose, dose-ranging study of autologous, chimeric antigen receptor T regulatory cells (CAR-Treg) in HLA-A2 mismatched living donor kidney transplant recipients, with a control cohort of mismatched kidney transplant recipients of similar immunological risk.The aim is for the CAR-Tregs to recognise the HLA-A2 molecule present on the donated kidney and subsequently induce and maintain immunological tolerance to the organ.

The study requires two arms - transplant recipients who will receive the study treatment TX200-TR101and control participants, who are transplant recipients who will not receive the study treatment.

Being tested
TX200-TR101
Keywords
Regulatory T cells, Genetically modified cells, Chimeric Antigen Receptor, Living donor, Autologous
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TX200-TR101Biological

    Also called CAR-Tregs

    TX200-TR101 is an autologous gene therapy medicinal product composed of Treg cells (CD4+/CD45RA+/CD25+/CD127low/neg) that have been ex vivo expanded and transduced with a lentiviral vector encoding for a CAR to recognize HLA-A*02. Treatment will be given via an IV infusion at a pre-defined timepoint several weeks after transplant. Four, single ascending dose cohorts of TX200-TR101 are planned and an additional expansion cohort.

Study groups in NCT04817774
Study groupRoleWhat they receive
Treatment groupExperimentalSubjects undergo kidney transplant as per planned standard of care and are administered study drug post transplantation.
Receives: Biological: TX200-TR101
Control groupNo interventionControl group: Subjects undergo kidney transplant as per planned standard of care with no study drug administered.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Short Term Safety and Tolerability of TX200-TR101 Infusion.

    Incidence and grade of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) according to CTCAE V5.0.

    Measured: 28 days post infusion

Secondary outcomes (6)

  1. Acute Graft Related Outcomes

    Incidence of biopsy confirmed acute rejection according to the Banff classification criteria

    Measured: Day of infusion through to Week 84

  2. Long-term Safety

    Number of transplant recipient subjects with TEAEs, including SAEs, as assessed by CTCAE v5.0

    Measured: Day of infusion through to Week 84

  3. Immunosuppression

    Ability to reduce immunosuppression as measured by the proportion of subjects receiving tacrolimus monotherapy at Week 84

    Measured: Day of infusion through to Week 84

  4. Graft Localization

    Graft localization of TX200-TR101 cells as measured by the presence of CD4+ CAR+ cells in the renal transplant biopsy

    Measured: Day of infusion through to Week 84

  5. Chronic Graft Related Outcomes

    Chronic graft dysfunction as measured by estimated glomerular filtration rate

    Measured: Day of infusion through to Week 84

  6. Chronic Graft Related Outcomes

    Incidence of chronic graft rejection according to the Banff criteria for chronic rejection

    Measured: Day of infusion through to Week 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2021
  2. Study start17 Mar 2021
  3. Primary completion11 Jul 2024
  4. Study completion16 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04817774
Sponsor's protocol ID
TX200 KT02
Other IDs
2019-001730-34, 2024-512579-11-00, 2019
Acronym
STEADFAST
Status last verified
Jun 2026
First submitted
9 Mar 2021
Last updated
2 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TX200-TR101 in people with Kidney Transplant Rejection and End Stage Renal Disease, run by Sangamo Therapeutics at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands, Belgium, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short Term Safety and Tolerability of TX200-TR101 Infusion. (time frame: 28 days post infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04817774.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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