Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
REgulatory T Cell Therapy to Achieve Immunosuppression REduction
NCT06552169 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this multi-national, multi-center, open-label, randomized Phase 2 trial is to determine the safety and efficacy of administering expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor renal transplant recipients. Enrolled subjects will be randomized to one of 2 study arms: Arm 1 subjects will receive standard of care immunosuppression Arm 2 subjects will receive initial standard of care (SOC) immunosuppression and a single infusion of TRK-001. Three months after the transplant, Arm 2 subjects may be able to begin reducing their immunosuppression medication to a 1-drug regimen. The primary outcome measures of trial are to evaluate several components indicating immunologic problems with the transplanted organ at 1-year post-transplant and to evaluate the ability for the study subjects given TRK-001 to wean to a 1-drug immunosuppression regimen. All enrolled subjects will be followed for 5 years post-transplant.
Conditions Studied
Interventions
- DRUG Arm 1: SOC (mTOR + CNI)
- BIOLOGICAL Arm 2A: TRACT/MONO mTOR
- BIOLOGICAL Arm 2B: TRACT/MONO CNI
Study Locations (7)
Other
- Taichung Veterans General Hospital — Taichung
- National Cheng Kung University Hospital — Tainan
- National Taiwan University Hospital — Taipei
- Chang Gung Medical Foundation Hospital — Taoyuan District
Arizona
- Mayo Clinic in Arizona — Phoenix
Illinois
- Northwestern Memorial Hospital — Chicago
Minnesota
- Mayo Clinic in Minnesota — Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2025-06-13 |
| Est. Completion | 2031-12 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06552169
The ClinicalTrials.gov registry entry for NCT06552169 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Singulera Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Kidney Transplantation appearing as the primary indexed condition, and to 3 interventions — of which Arm 1: SOC (mTOR + CNI) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06552169 reports 7 study locations spanning 4 distinct geographic areas — top geographies include Other, Arizona, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06552169 about?
NCT06552169 is a clinical study titled "REgulatory T Cell Therapy to Achieve Immunosuppression REduction". The goal of this multi-national, multi-center, open-label, randomized Phase 2 trial is to determine the safety and efficacy of administering expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor renal transplant recipients. Enrolled subjects will be randomized to one ...
What is the current status of trial NCT06552169?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2025-06-13. Estimated completion is 2031-12.
What conditions does trial NCT06552169 study?
This clinical trial studies the following conditions: Kidney Transplantation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06552169?
The interventions under investigation include: Arm 1: SOC (mTOR + CNI) (DRUG), Arm 2A: TRACT/MONO mTOR (BIOLOGICAL), Arm 2B: TRACT/MONO CNI (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06552169?
This trial is sponsored by Singulera Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06552169 being conducted?
This trial has 7 study locations across Arizona, Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.