A Phase 1/2 interventional study of TX200-TR101 in Kidney Transplant Rejection and End Stage Renal Disease, sponsored by Sangamo Therapeutics. Completed at 5 sites in 3 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Sangamo Therapeutics · Phase 1/2, Interventional, and Prevention
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.
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 26 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Sangamo Therapeutics is the lead sponsor of 27 studies on the registry; 1 is open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects undergo kidney transplant as per planned standard of care and are administered study drug post transplantation.
Biological: TX200-TR101
Control group: Subjects undergo kidney transplant as per planned standard of care with no study drug administered.
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.
Also known as: CAR-Tregs
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.
Time frame: 28 days post infusion
Acute Graft Related Outcomes
Incidence of biopsy confirmed acute rejection according to the Banff classification criteria
Time frame: Day of infusion through to Week 84
Long-term Safety
Number of transplant recipient subjects with TEAEs, including SAEs, as assessed by CTCAE v5.0
Time frame: Day of infusion through to Week 84
Immunosuppression
Ability to reduce immunosuppression as measured by the proportion of subjects receiving tacrolimus monotherapy at Week 84
Time frame: Day of infusion through to Week 84
Graft Localization
Graft localization of TX200-TR101 cells as measured by the presence of CD4+ CAR+ cells in the renal transplant biopsy
Time frame: Day of infusion through to Week 84
Chronic Graft Related Outcomes
Chronic graft dysfunction as measured by estimated glomerular filtration rate
Time frame: Day of infusion through to Week 84
Chronic Graft Related Outcomes
Incidence of chronic graft rejection according to the Banff criteria for chronic rejection
Time frame: Day of infusion through to Week 84
Participants were recruited from across 5 transplant centers between March 2021 and September 2023. All 13 participants met the inclusion criteria and proceeded to the transplant.13 participants were kidney recipients. DL = dose level
| Milestone | Treatment With TX200-TR101 (DL1) | Treatment With TX200-TR101 (DL2) | Treatment With TX200-TR101 (DL3) | Treatment With TX200-TR101 (DL4) | Controls | Donors |
|---|---|---|---|---|---|---|
| Started | 4 | 1 | 1 | 3 | 4 | 13 |
| Transplant | 4 | 1 | 1 | 3 | 4 | 13 |
| Week 12 | 3 | 1 | 1 | 3 | 3 | 0 |
| Week 16 | 3 | 1 | 1 | 3 | 3 | 0 |
| Week 84 | 3 | 1 | 1 | 3 | 3 | 0 |
| Completed | 3 | 1 | 1 | 3 | 3 | 13 |
| Not completed | 1 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 | 1 | 0 |
Incidence and grade of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) according to CTCAE V5.0.
| Participants | Treatment With TX200-TR101 (DL1) | Treatment With TX200-TR101 (DL2) | Treatment With TX200-TR101 (DL3) | Treatment With TX200-TR101 (DL4) | Controls | Donors |
|---|---|---|---|---|---|---|
| Number of participants with TEAEs < grade 3 | 1 | 0 | 0 | 1 | 2 | 0 |
| Number of participants with TEAEs >= grade 3 | 1 | 0 | 0 | 0 | 0 | 0 |
| Number of participants with no TEAEs | 1 | 1 | 1 | 2 | 1 | 13 |
Incidence of biopsy confirmed acute rejection according to the Banff classification criteria
Results for this outcome have not been posted.
Number of transplant recipient subjects with TEAEs, including SAEs, as assessed by CTCAE v5.0
Results for this outcome have not been posted.
Ability to reduce immunosuppression as measured by the proportion of subjects receiving tacrolimus monotherapy at Week 84
Results for this outcome have not been posted.
Graft localization of TX200-TR101 cells as measured by the presence of CD4+ CAR+ cells in the renal transplant biopsy
Results for this outcome have not been posted.
Chronic graft dysfunction as measured by estimated glomerular filtration rate
Results for this outcome have not been posted.
Incidence of chronic graft rejection according to the Banff criteria for chronic rejection
Results for this outcome have not been posted.
Collected over Adverse event data was collected from the subject's date of consent until their end of study visit at week 84. For ongoing subjects adverse event data is reported up to the data cut of 22Nov2024.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment With TX200-TR101 (DL1) | 0/4 (0%) | 2/4 (50%) | 4/4 (100%) |
| Treatment With TX200-TR101 (DL2) | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Treatment With TX200-TR101 (DL3) | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) |
| Treatment With TX200-TR101 (DL4) | 0/3 (0%) | 2/3 (66.7%) | 3/3 (100%) |
| Controls | 0/4 (0%) | 2/4 (50%) | 4/4 (100%) |
| Donors | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Event | Treatment With TX200-TR101 (DL1) | Treatment With TX200-TR101 (DL2) | Treatment With TX200-TR101 (DL3) | Treatment With TX200-TR101 (DL4) | Controls | Donors |
|---|---|---|---|---|---|---|
| Blood creatinine increasedInvestigations | 0/4 | 0/1 | 1/1 | 0/3 | 0/4 | 0/13 |
| Catheter site haemorrhageGeneral disorders | 0/4 | 0/1 | 0/1 | 1/3 | 0/4 | 0/13 |
| Ureteric obstructionRenal and urinary disorders | 0/4 | 0/1 | 0/1 | 1/3 | 0/4 | 0/13 |
| LymphoceleVascular disorders | 0/4 | 0/1 | 0/1 | 1/3 | 0/4 | 0/13 |
| GastroenteritisInfections and infestations | 1/4 | 0/1 | 0/1 | 0/3 | 1/4 | 0/13 |
| PyelonephritisInfections and infestations | 1/4 | 0/1 | 0/1 | 0/3 | 0/4 | 0/13 |
| MalaiseGeneral disorders | 1/4 | 0/1 | 0/1 | 0/3 | 0/4 | 0/13 |
| Renal impairmentRenal and urinary disorders | 1/4 | 0/1 | 0/1 | 0/3 | 0/4 | 0/13 |
| HypotensionVascular disorders | 0/4 | 0/1 | 0/1 | 0/3 | 1/4 | 0/13 |
| IleusGastrointestinal disorders | 1/4 | 0/1 | 0/1 | 0/3 | 0/4 | 0/13 |
| Event | Treatment With TX200-TR101 (DL1) | Treatment With TX200-TR101 (DL2) | Treatment With TX200-TR101 (DL3) | Treatment With TX200-TR101 (DL4) | Controls | Donors |
|---|---|---|---|---|---|---|
| Folate deficiencyMetabolism and nutrition disorders | 1/4 | 1/1 | 0/1 | 0/3 | 1/4 | 0/13 |
| HypophosphataemiaMetabolism and nutrition disorders | 1/4 | 1/1 | 0/1 | 0/3 | 1/4 | 0/13 |
| HypercalcaemiaMetabolism and nutrition disorders | 0/4 | 1/1 | 0/1 | 0/3 | 1/4 | — |
| HyperlipidaemiaMetabolism and nutrition disorders | 0/4 | 1/1 | 0/1 | 0/3 | 1/4 | — |
| Vitamin D deficiencyMetabolism and nutrition disorders | 0/4 | 0/1 | 1/1 | 1/3 | 1/4 | — |
| HypokalaemiaMetabolism and nutrition disorders | 0/4 | 0/1 | 1/1 | 0/3 | 0/4 | — |
| HyperuricaemiaMetabolism and nutrition disorders | 0/4 | 1/1 | 0/1 | 0/3 | 0/4 | — |
| Steroid diabetesMetabolism and nutrition disorders | 0/4 | 1/1 | 0/1 | 0/3 | 0/4 | — |
| VomitingGastrointestinal disorders | 0/4 | 0/1 | 1/1 | 0/3 | 1/4 | — |
| Apthous ulcerGastrointestinal disorders | 0/4 | 1/1 | 0/1 | 0/3 | 0/4 | — |
Kidney transplant donors (who completed the study after transplantation) and kidney recipients who reached 12 weeks post-transplant visit.
| Age, Categorical(Participants) | Treatment With TX200-TR101 (DL1) | Treatment With TX200-TR101 (DL2) | Treatment With TX200-TR101 (DL3) | Treatment With TX200-TR101 (DL4) | Controls | Donors | Total |
|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 1 | 1 | 2 | 3 | 11 | 21 |
| >=65 years | 0 | 0 | 0 | 1 | 0 | 2 | 3 |
| Sex: Female, Male(Participants) | Treatment With TX200-TR101 (DL1) | Treatment With TX200-TR101 (DL2) | Treatment With TX200-TR101 (DL3) | Treatment With TX200-TR101 (DL4) | Controls | Donors | Total |
|---|---|---|---|---|---|---|---|
| Female | 0 | 1 | 1 | 0 | 1 | 4 | 7 |
| Male | 3 | 0 | 0 | 3 | 2 | 9 | 17 |
| Race (NIH/OMB)(Participants) | Treatment With TX200-TR101 (DL1) | Treatment With TX200-TR101 (DL2) | Treatment With TX200-TR101 (DL3) | Treatment With TX200-TR101 (DL4) | Controls | Donors | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 2 | 1 | 0 | 1 | 2 | 8 | 14 |
| More than one race | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 1 | 0 | 1 | 1 | 1 | 5 | 9 |
| Ethnicity (NIH/OMB)(Participants) | Treatment With TX200-TR101 (DL1) | Treatment With TX200-TR101 (DL2) | Treatment With TX200-TR101 (DL3) | Treatment With TX200-TR101 (DL4) | Controls | Donors | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 2 | 1 | 1 | 3 | 2 | 11 | 20 |
| Unknown or Not Reported | 1 | 0 | 0 | 0 | 1 | 2 | 4 |
| Region of Enrollment(Participants) | Treatment With TX200-TR101 (DL1) | Treatment With TX200-TR101 (DL2) | Treatment With TX200-TR101 (DL3) | Treatment With TX200-TR101 (DL4) | Controls | Donors | Total |
|---|---|---|---|---|---|---|---|
| Netherlands | 2 | 0 | 1 | 2 | 2 | 8 | 15 |
| Belgium | 1 | 1 | 0 | 0 | 1 | 4 | 7 |
| United Kingdom | 0 | 0 | 0 | 1 | 0 | 1 | 2 |
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