REgulatory T Cell Therapy to Achieve Immunosuppression REduction (NCT06552169)
The RETIRE Trial: A Randomized Phase 2 Trial of Adoptive Therapy With Treg Adoptive Cell Transfer (TRACT) To Prevent Rejection in Living Donor Kidney Transplant Recipients
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (36 items).
Location: Mayo Clinic in Arizona — Phoenix, Arizona
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria Based on SOC Pre-Transplant Evaluation The following exclusion criteria must be determined prior to randomization per SOC pre-transplant evaluation.
- Known sensitivity or contraindication to thymoglobulin, everolimus, sirolimus, or tacrolimus or other immunosuppression medication prescribed.
- Subjects with a positive crossmatch by virtual cross matching or complement-dependent cytotoxicity (CDC) cross matching or flow cytometry cross matching (FCXM).
- Subjects with PRA \>80% per SOC pre-transplant assessment. PRA must be repeated prior to transplant if patient receives a blood product transfusion after the initial assessment.
- Subjects with current or historic donor specific antibodies.
- Body Mass Index (BMI) of \< 16 kg/m2 or \> 38 kg/m2 per SOC pre-transplant evaluation.
- Subjects who are pregnant or nursing mothers.
- Subjects whose life expectancy is severely limited by diseases other than renal disease, per judgement of an investigator.
- Ongoing active drug or alcohol substance abuse, per judgement of an investigator.
- Major ongoing psychiatric illness or recent history of noncompliance with current medical therapy, per judgement of an investigator.
- Significant cardiovascular disease (e.g.):
- Significant non-correctable coronary artery disease, per judgement of an investigator
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (7 Sites)
- Mayo Clinic in Arizona — Phoenix, Arizona
- Northwestern Memorial Hospital — Chicago, Illinois
- Mayo Clinic in Minnesota — Rochester, Minnesota
- Taichung Veterans General Hospital — Taichung,
- National Cheng Kung University Hospital — Tainan,
- National Taiwan University Hospital — Taipei,
- Chang Gung Medical Foundation Hospital — Taoyuan,
📞 Contact the Study Coordinator
Phone: (312) 219-4670
Email: susan.murray@singulera-tx.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: 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) immunosuppre...
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.