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NCT06552169 · ClinicalTrials.gov registry record · Phase 2
REgulatory T Cell Therapy to Achieve Immunosuppression REduction
A Phase 2 study of Kidney Transplantation, sponsored by Singulera Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 7
- Study locations
NCT06552169: Recruiting Phase 2 study of Kidney Transplantation, sponsored by Singulera Therapeutics.
NCT06552169 is a Phase 2 study of Kidney Transplantation that is actively recruiting participants, run by Singulera Therapeutics. The registered enrollment target is 34 participants, below the 267-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (87% lower). The trial reports 7 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06552169, a Phase 2 study of Kidney Transplantation, is actively recruiting participants, sponsored by Singulera Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
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.
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 |
What NCT06552169 shows while recruiting
NCT06552169 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 267-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (87% lower).
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.
NCT06552169 lists 7 locations in 4 states (Other, Arizona, Illinois).
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.
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).
Who is sponsoring clinical trial NCT06552169?
This trial is sponsored by Singulera Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
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
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Where NCT06552169's enrollment target sits among peer trials
34 27th of 33 higher than 7 of 33 other Kidney Transplantation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Transplantation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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