REgulatory T Cell Therapy to Achieve Immunosuppression REduction

Recruiting now · Phase 2

Conditions studied: Kidney Transplantation

In brief

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.

Key facts

Study ID: NCT06552169
Run by: Singulera Therapeutics Inc.
People needed: 34
Starts: 2025-06-13
Expected to finish: 2031-12-01
Last updated by the study team: 2026-04-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All inclusion criteria must be met prior to randomization.
Males or females aged 18-65 years as of the date of informed consent who will undergo a single organ, living donor kidney transplant.
Donor aged 18-65 years as of the date of organ donation. A certain degree of HLA matching between the donor and the recipient is not required.
Blood type compatibility between recipient and donor must be established as follows.
Recipient A to Donor A or O; Recipient B to Donor B or O; Recipient AB to Donor A, B, AB, or O; Recipient O to Donor O.
No prior organ transplant of any kind.
Women of childbearing potential must agree to use a medically acceptable method of contraception throughout the trial. A list of the medically acceptable methods of contraception are listed in the informed consent document.
Male patients must agree to use birth control following the initiation of standard-of-care immunosuppression and for a minimum of 6 months following kidney transplant.
Subjects (recipients) must be able to understand the consent form and give written informed consent prior to any trial procedure.
If donor informed consent is required by IRB/IEC, donor must be able to understand the consent form and give written informed consent prior to any trial procedure. Note: Donor informed consent is required for donors participating in the research assay collections.
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
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

Where it is running

Taichung Veterans General Hospital — Taichung, Taiwan (enrolling)
Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
Mayo Clinic in Minnesota — Rochester, Minnesota, United States (enrolling)
Mayo Clinic in Arizona — Phoenix, Arizona, United States (enrolling)
Chang Gung Medical Foundation Hospital — Taoyuan, Taiwan (enrolling)
National Taiwan University Hospital — Taipei, Taiwan (enrolling)
National Cheng Kung University Hospital — Tainan, Taiwan

Full record on ClinicalTrials.gov

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