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Kidney Transplant Study: Reducing Immunosuppression with TRK-001

This study is looking at a new way to help people who have received a living donor kidney transplant. It's testing a treatment called TRK-001, which uses your own expanded regulatory T cells (a type of immune cell), to see if it can prevent your body from rejecting the new kidney. The goal is to see if TRK-001 can allow patients to take fewer immunosuppression medications over time. You would be randomly assigned to either receive standard care (tacrolimus + sirolimus or everolimus) or standard care plus a single infusion of TRK-001. After three months, those receiving TRK-001 might be able to reduce their medication to just one drug. The study will measure if you develop new antibodies against the donor kidney or experience rejection within 12 months. This study is for people aged 18-65 who are having a living donor kidney transplant. The current recruitment status is unclear.

Study design
This is a randomized, open-label study involving 34 participants. It compares standard immunosuppression to standard immunosuppression plus TRK-001, with some participants potentially reducing their medication later.
What's involved
Participants will be followed for 5 years post-transplant, including a 2-year follow-up and a 3-year surveillance period.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years after their transplant, which includes a 2-year follow-up and a 3-year surveillance period.

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NCT06552169

REgulatory T Cell Therapy to Achieve Immunosuppression REduction

Recruiting
PHASE2Ages 18–65InterventionalPrevention
Singulera Therapeutics Inc.
~34 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:Arm 1: SOC (mTOR + CNI)Arm 2A: TRACT/MONO mTORArm 2B: TRACT/MONO CNI

At a glance

Recruiting sites
6 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Development of de novo donor-specific antibodies
Measured over Month 12 Post-transplant
+4 more outcomes measured

Conditions

Kidney Transplantation

Explore related trials

Chronic Kidney Disease, Stage 5Kidney Transplantation

Where it's being run

7 sites across 4 states
Taiwan4
Arizona1
Illinois1
Minnesota1

Who to contact

Susan B Murray
[email protected]
+1-312-219-4670
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Significant non-correctable coronary artery disease, per judgement of an investigator
Ejection fraction below 30% per SOC echocardiogram if an echocardiogram is performed for an individual subject as part of their pre-transplant evaluation
History of recent (\< 12 months) myocardial infarction at time of informed consent
History of recent (within 3 months) vascular intervention(s) for coronary artery disease at the time of informed consent
Documented arrhythmias that require a pacemaker or medical therapy for control. 11. Subjects who require use of chronic anticoagulation medications. Use of anti-platelet medications will be allowed in absence of a documented arrhythmia. 12. Malignancy within 3 years, excluding non-melanoma skin cancers such as basal cell carcinoma and squamous cell carcinoma. 13. Serologic evidence of active infection with HCV, HIV or HBV per SOC pre-transplant evaluation. Historical data within three months of transplant are acceptable. 14. Subjects with a total white blood cell count \< 4,000/mm3; platelet count \< 50,000/mm3; triglyceride \> 400 mg/dL; total cholesterol \> 300 mg/dL, prothrombin time \<8.4 seconds or \>15.7 seconds, activated partial thromboplastin time \<21.6 or \> 42.3 seconds, fibrinogen \<177 mg/dL or \>598 mg/dL, and INR \<0.64 or \>1.4. 15. Subjects with underlying renal disease etiologies with high risk of disease recurrence such as primary focal segmental glomerulosclerosis and others per investigator discretion. 16. Subjects requiring the use of chronic immunosuppressive medication to control an underlying renal disease, or a disease with extrarenal manifestations (i.e., inflammatory bowel disease). Subjects requiring chronic or intermittent use of inhaled corticosteroids for respiratory conditions will be allowed. 17. Diabetic subjects with an HbA1c of \>8%.

What this trial measures

  • Development of de novo donor-specific antibodiesMonth 12 Post-transplant

    A primary outcome measure for this study is to evaluate a composite endpoint of immunologic events against the allograft, where a failure is defined as patient-experienced immunologic events including the development of de novo donor-specific antibodies.

  • Biopsy-proven acute rejectionMonth 12 Post-transplant

    A primary outcome measure for this study is to evaluate a composite endpoint of immunologic events against the allograft, where a failure is defined as patient-experienced immunologic events including biopsy-proven acute rejection.

  • Biopsy-proven subclinical rejectionMonth 12 Post-transplant

    A primary outcome measure for this study is to evaluate a composite endpoint of immunologic events against the allograft, where a failure is defined as patient-experienced immunologic events including biopsy-proven subclinical rejection.

  • Development of significant (2+) interstitial fibrosis/tubular atrophyMonth 12 Post-transplant

    A primary outcome measure for this study is to evaluate a composite endpoint of immunologic events against the allograft, where a failure is defined as patient-experienced immunologic events including the development of significant (2+) interstitial fibrosis/tubular atrophy.

  • Successful taper to monotherapy (Arm 2)Month 12 Post-transplant

    A primary outcome measure for this study is to evaluate the ability for Arm 2 subjects to successfully taper to monotherapy by one-year post-transplant.