Status:
RECRUITING
REgulatory T Cell Therapy to Achieve Immunosuppression REduction
Lead Sponsor:
Singulera Therapeutics Inc.
Collaborating Sponsors:
Taiwan Bio Therapeutics Inc.
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
This is a prospective, multi-national, multi-center, open-label, randomized Phase 2 trial to determine the safety and efficacy of administering autologous expanded regulatory T cells (TRK-001) to prev...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Known sensitivity or contraindication to thymoglobulin, everolimus, sirolimus, or tacrolimus or other immunosuppression medication prescribed.
- Subjects with an active infection considered clinically significant by an investigator that has not resolved prior to transplant.
- Subjects with a positive flow cytometric crossmatch using donor lymphocytes and recipient serum.
- 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
- History of recent (within 3 months) vascular intervention(s) for coronary artery disease at the time of informed consent
- Documented arrhythmias that require a pacemaker or medical therapy for control.
- Subjects who require use of chronic anticoagulation medications. Use of anti-platelet medications will be allowed in absence of a documented arrhythmia.
- Malignancy within 3 years, excluding non-melanoma skin cancers such as basal cell carcinoma and squamous cell carcinoma.
- Serologic evidence of active infection with HCV, HIV or HBV per SOC pre-transplant evaluation.
- Subjects with a total white blood cell count \< 4,000/mm3; platelet count \< 50,000/mm3; triglyceride \> 400 mg/dL; total cholesterol \> 300 mg/dL, prothrombin time \<8.4 seconds or \>15.7 seconds, activated partial thromboplastin time \<21.6 seconds or \>42.3 seconds, fibrinogen \<177 mg/dL or \>598 mg/dL, and INR \<0.64 or \>1.4.
- Subjects with underlying renal disease etiologies with high risk of disease recurrence such as primary focal segmental glomerulosclerosis and others per investigator discretion.
- Subjects requiring the use of chronic immunosuppressive medication to control an underlying renal disease, or a disease with extrarenal manifestations (i.e., inflammatory bowel disease). Subjects requiring chronic or intermittent use of inhaled corticosteroids for respiratory conditions will be allowed.
- Diabetic subjects with an HbA1c of \>8%.
- Exclusion Criteria Prior to Leukapheresis (Arm 2)
- Subjects with an active infection considered clinically significant by an investigator that has not resolved prior to leukapheresis.
- Subjects with PRA \>80%, if repeated after SOC pre-transplant assessment. (PRA must be repeated prior to leukapheresis if patient receives a blood product transfusion after the initial assessment).
- Subjects who are pregnant or nursing.
- Subjects who received an investigational drug within 30 days prior to leukapheresis.
- Subjects who received anti-T cell therapy within 30 days prior to leukapheresis.
- Subjects who do not meet pre-leukapheresis clearance parameters per institutional practices or per investigator discretion.
- Exclusion Criteria Prior to TRACT Cellular Product Infusion (Arm 2)
- Subjects with an active infection considered clinically significant by the investigator that has not resolved prior to planned Treg infusion.
- Subjects with a new, clinically significant medical condition that, per investigator opinion, would impact the ability to safely administer TRK-001.
- Subjects who experience a rejection episode of the kidney graft prior to the planned Treg infusion.
- Subjects who are pregnant or nursing. Women who are of childbearing potential must have a negative urine or serum pregnancy test before infusion of TRK-001.
- Subjects who received an investigational drug within 30 days prior to infusion.
- Subjects who received anti-T cell therapy within 30 days prior to infusion.
Exclusion
Key Trial Info
Start Date :
June 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2031
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06552169
Start Date
June 13 2025
End Date
June 1 2031
Last Update
November 4 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
2
Taichung Veterans General Hospital
Taichung, Taiwan, 407219
3
National Taiwan University Hospital
Taipei, Taiwan, 100229
4
Chang Gung Medical Foundation Hospital
Taoyuan District, Taiwan, 333