Kidney Transplant RejectionNCT05987527
Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)
An observational study of Kidney Transplant Rejection and End Stage Renal Disease, run by Sangamo Therapeutics at 5 sites in 3 countries.
Trial summary
This long-term follow-up study is being conducted to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Kidney Transplant Rejection, End Stage Renal Disease
- What is being tested?
- Blood sample
- How many people
- 11 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 15 Aug 2023to 11 Jun 2039
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Transplant recipients enrolled in the Phase I/IIa study (TX200-KT02) and who have consented to participate in this LTFU study,
Who may be able to join
- Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study.
- Willing and able to provide written informed consent (IC) in accordance with local regulations and governing Independent Ethics Committee (IEC)/Institutional Review Board (IRB) requirements prior to any procedure or evaluation performed specifically for the sole purpose of the study.
Who cannot join
- N/A
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
Erasmus MC, University Medical Center
Rotterdam
United Kingdom1 site
Oxford University Hospitals NHS Foundation Trust
Oxford
About this study
Official title: Long-Term Follow-Up of Patients Who Have Received an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (CAR- Treg Therapy, TX200-TR101) in a Prior Clinical Study
This long-term follow-up study is being conducted to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101.
Read the detailed description
This is long- term follow up observational trial for patients who participated previously to 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 this observational long-term follow up study (TX200-KT03) is to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101.
- Being tested
- Blood sample
- Keywords
- Regulatory T-Cells, Genetically modified cells, Chimeric antigen receptor, Long term follow up, T-Regs, Cell Therapy
- 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.
Blood sampleDiagnostic test
Routine procedures
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Subjects underwent a kidney transplant as per planned standard of care and were administered study drug TX200-TR101 in study TX200-KT02 post transplantation
Assigned interventions - subjects who received TX200-TR101 in clinical study TX200-KT02 Receives: Diagnostic Test: Blood sample | |
| Control group | Subjects underwent a kidney transplant as per planned standard of care in study TX200-KT02 with no study drug administered Receives: Diagnostic Test: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of TX200-TR101 infusion evaluated by overall survival
Long term safety and tolerability of TX200-TR101 infusion evaluated by overall survival
Measured: Up to 15 years post infusion
Safety and Tolerability TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.
Long term safety and tolerability of TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.
Measured: Up to 15 years post infusion
Secondary outcomes (8)
Long term graft related outcomes
Incidence of graft rejection according to the Banff classification criteria
Measured: Up to 15 years post infusion
Number of in-patient days in hospital to evaluate the effect of TX200-TR101 over a long term
Number of in-patient days in hospital
Measured: Up to 15 years post infusion
Incidence of Adverse Events related to TX200-TR101 over a long term period
Incidence of Adverse Events related to TX200-TR101
Measured: Up to 15 years post infusion
Incidence of Adverse Events of special interest as defined in the protocol over long term
Incidence of Adverse Events of special interest as defined in the protocol
Measured: Up to 15 years post infusion
Change in immunosuppression regime to evaluate long term safety of TX200-TR101
Change in immunosuppression regime
Measured: Up to 15 years post infusion
Incidence of graft loss due to rejection to evaluate the composite efficacy profile of TX200-TR101
Incidence of graft loss due to rejection
Measured: Up to 15 years post infusion
Incidents of deaths to evaluate composite efficacy profile of TX200-TR101
Incidences of death of TX200-TR101 participants
Measured: Up to 15 years post infusion
Incidence of chronic graft dysfunction measured by changes in estimated glomerular filtration rate to evaluate the composite efficacy profile of TX200-TR101
Incidence of chronic graft dysfunction measured by changes in estimated glomerular filtration rate
Measured: Up to 15 years post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start15 Aug 2023
- Primary completion11 Jun 2039 (estimated)
- Study completion11 Jun 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sangamo Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987527
- Sponsor's protocol ID
- TX200-KT03
- Other IDs
- 2022-002440-40
- Status last verified
- Dec 2025
- First submitted
- 30 Jun 2023
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-Up of Patients Who Have Received an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (CAR- Treg Therapy, TX200-TR101) in a Prior Clinical Study
- ClinicalTrials.gov ID
- NCT05987527
- Acronym / sponsor ID
- TX200-KT03
- Keywords
- Regulatory T-Cells, Genetically modified cells, Chimeric antigen receptor, Long term follow up, T-Regs, Cell Therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Sangamo TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 11 Jun 2039 (estimated)
- Study completion
- 11 Jun 2039 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This long-term follow-up study is being conducted to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101.
Detailed description
This is long- term follow up observational trial for patients who participated previously to 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 this observational long-term follow up study (TX200-KT03) is to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Diagnostic Test: Blood sampleSubjects underwent a kidney transplant as per planned standard of care and were administered study drug TX200-TR101 in study TX200-KT02 post transplantation Assigned interventions - subjects who received TX200-TR101 in clinical study TX200-KT02 |
| Control group | – | Diagnostic Test: Blood sampleSubjects underwent a kidney transplant as per planned standard of care in study TX200-KT02 with no study drug administered |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Transplant recipients enrolled in the Phase I/IIa study (TX200-KT02) and who have consented to participate in this LTFU study,
Key inclusion criteria (2 listed)
- Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study.
- Willing and able to provide written informed consent (IC) in accordance with local regulations and governing Independent Ethics Committee (IEC)/Institutional Review Board (IRB) requirements prior to any procedure or evaluation performed specifically for the sole purpose of the study.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleRoutine procedures | Diagnostic test | Control group, Treatment group |
Primary outcome
Safety and Tolerability of TX200-TR101 infusion evaluated by overall survival
Time frame: Up to 15 years post infusion
Long term safety and tolerability of TX200-TR101 infusion evaluated by overall survival
Safety and Tolerability TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.
Time frame: Up to 15 years post infusion
Long term safety and tolerability of TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.
8 secondary outcomes
Long term graft related outcomes
Time frame: Up to 15 years post infusion
Number of in-patient days in hospital to evaluate the effect of TX200-TR101 over a long term
Time frame: Up to 15 years post infusion
Incidence of Adverse Events related to TX200-TR101 over a long term period
Time frame: Up to 15 years post infusion
Incidence of Adverse Events of special interest as defined in the protocol over long term
Time frame: Up to 15 years post infusion
Change in immunosuppression regime to evaluate long term safety of TX200-TR101
Time frame: Up to 15 years post infusion
Incidence of graft loss due to rejection to evaluate the composite efficacy profile of TX200-TR101
Time frame: Up to 15 years post infusion
Incidents of deaths to evaluate composite efficacy profile of TX200-TR101
Time frame: Up to 15 years post infusion
Incidence of chronic graft dysfunction measured by changes in estimated glomerular filtration rate to evaluate the composite efficacy profile of TX200-TR101
Time frame: Up to 15 years post infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Link to parent study STEADFAST, TX200-KT02Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Safety and Tolerability of TX200-TR101 infusion evaluated by overall survival (time frame: Up to 15 years post infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2025.