Actively Recruiting
REgulatory T Cell Therapy to Achieve Immunosuppression REduction
Led by Singulera Therapeutics Inc. · Updated on 2026-04-27
34
Participants Needed
7
Research Sites
337 weeks
Total Duration
On this page
Sponsors
S
Singulera Therapeutics Inc.
Lead Sponsor
T
Taiwan Bio Therapeutics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
REgulatory T Cell Therapy to Achieve Immunosuppression REduction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18-65 years who will undergo a single living donor kidney transplant
- Donor aged 18-65 years
- Blood type compatibility between recipient and donor 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 medically acceptable contraception throughout the trial
- Male patients must agree to use birth control following immunosuppression initiation and for at least 6 months after transplant
- Ability to understand and provide written informed consent
- Donor must provide written informed consent if required by review boards
You will not qualify if you...
- Known sensitivity or contraindication to thymoglobulin, everolimus, sirolimus, tacrolimus, or other immunosuppressive medications
- Positive crossmatch by virtual, CDC, or flow cytometry methods
- Panel reactive antibody (PRA) level greater than 80% prior to transplant or leukapheresis
- Presence of current or historic donor specific antibodies
- Body Mass Index less than 16 kg/m2 or greater than 38 kg/m2
- Pregnancy or nursing
- Limited life expectancy due to diseases other than renal disease
- Active substance abuse
- Major psychiatric illness or recent noncompliance with medical therapy
- Significant cardiovascular disease such as severe coronary artery disease, low ejection fraction below 30%, recent myocardial infarction, recent coronary interventions, or arrhythmias requiring pacemaker or medication
- Need for chronic anticoagulation medication (antiplatelet drugs allowed without arrhythmia)
- Malignancy within 3 years except certain skin cancers
- Active infection with HCV, HIV, or HBV
- Low white blood cell or platelet counts, abnormal blood clotting tests, or high triglyceride/cholesterol levels
- Underlying renal diseases with high risk of recurrence or requiring chronic immunosuppressive medications
- Diabetes with HbA1c greater than 8%
- Active infection considered clinically significant prior to transplant, leukapheresis, or cell infusion
- Receipt of investigational drugs or anti-T cell therapy within 30 days prior to leukapheresis or infusion
- New medical conditions impacting safe administration of TRK-001
- Rejection episode prior to planned TRK-001 infusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Mayo Clinic in Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
3
Mayo Clinic in Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
4
Taichung Veterans General Hospital
Taichung, Taiwan, 407219
Actively Recruiting
5
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Not Yet Recruiting
6
National Taiwan University Hospital
Taipei, Taiwan, 100229
Actively Recruiting
7
Chang Gung Medical Foundation Hospital
Taoyuan, Taiwan, 333
Actively Recruiting
Research Team
S
Susan B Murray
CONTACT
E
Erwin Teng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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