Clinical Trials List
Protocol NumberTRACT-KD-101
NCT Number(ClinicalTrials.gov Identfier)NCT06552169
Active
2024-12-30 - 2031-06-30
Phase II
Recruiting4
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
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/09
Investigators and Locations
Co-Principal Investigator
- Kuan-Der Lee Division of General Internal Medicine
- Ming-Ju Wu Division of Nephrology
- Cheng-Kuang Yang Division of Urology
- Cheng-Che Chen Division of Urology
- TUNG-MIN YU Division of Nephrology
- 蔡尚峰 Division of Nephrology
- 黃士婷 Division of Nephrology
- 邱顯富 Division of Nephrology
- 鍾牧圻 Division of Nephrology
- Chia-Yen Lin Division of Urology
- 吳致瑩 Division of Others
- Jian-Ri Li Division of Urology
- 許永楨 Division of Others
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- MENG-KUN TSAI Division of General Surgery
- 陳建嘉 Division of General Surgery
- 林維洲 Division of Others
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ya-Chung Tian Division of Nephrology
- Kun-Hua Tu Division of Nephrology
- 王敘涵 Division of Urology
- 吳欣旭 Division of Nephrology
- 陳泰迪 Division of Others
- 余美靜 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Shen-Shun Chang
Co-Principal Investigator
- Sin-Syue Li Division of Hematology & Oncology
- 陳盈妊 Division of Others
- 黃絜歆 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Kidney Transplantation
Objectives
Determine the safety and efficacy of autologous expansion of regulatory T cells (Tregs) infusion into living donor kidney transplant recipients.
Test Drug
Suspension Injection
Active Ingredient
Autologous ex vivo expanded natural regulatory T cells (Tregs)
Dosage Form
275
Dosage
1.0 - 5.0 x 10^9 Treg細胞
Endpoints
The primary outcome measure of this trial was to assess the immunological failure composite index in all subjects one year post-transplantation; failure was defined as any of the following:
• the presence of newly generated donor-specific antibodies, or
• acute rejection confirmed by biopsy, or
• subclinical rejection confirmed by biopsy, or
• significant (2+) interstitial fibrosis/renal tubular atrophy based on a biopsy with just cause/standard care
and to assess the ability of Group 2 subjects to successfully tape off to single therapy one year post-transplantation.
• the presence of newly generated donor-specific antibodies, or
• acute rejection confirmed by biopsy, or
• subclinical rejection confirmed by biopsy, or
• significant (2+) interstitial fibrosis/renal tubular atrophy based on a biopsy with just cause/standard care
and to assess the ability of Group 2 subjects to successfully tape off to single therapy one year post-transplantation.
Inclution Criteria
Inclusion Criteria
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.
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
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
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. Historical data within three months of transplant are acceptable.
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 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%.
The following exclusion criteria must be determined prior to transplant per SOC pre-transplant evaluation.
Subjects with an active infection considered clinically significant by an investigator that has not resolved prior to transplant.
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.
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
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. Historical data within three months of transplant are acceptable.
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 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%.
The following exclusion criteria must be determined prior to transplant per SOC pre-transplant evaluation.
Subjects with an active infection considered clinically significant by an investigator that has not resolved prior to transplant.
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.
The Estimated Number of Participants
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Taiwan
24 participants
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Global
34 participants
