[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558519":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":43,"centralContacts":44,"locations":54,"responsibleParty":150,"collaborators":152,"id":155,"slug":156,"hasResults":157,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":157,"sex":163,"minAge":164,"maxAge":165,"enrollmentInfo":166,"targetDuration":43,"studyType":169,"phases":170,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":57,"whyStopped":43,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},{"fullName":5,"class":6},"Singulera Therapeutics Inc.","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Standard of Care (SOC)","ACTIVE_COMPARATOR","Arm 1: SOC-Subjects randomized to Arm 1 will be followed on the prescribed 2-drug SOC immunosuppression throughout the trial.\n\nThe study allowed SOC regimen is tacrolimus + sirolimus or everolimus.",[13],"Drug: Arm 1: SOC (mTOR + CNI)",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2A: TRACT\u002FMONO mTOR","EXPERIMENTAL","Arm 2: TRACT\u002FMONO- At the beginning of the trial, subjects randomized to Arm 2 will be maintained on the prescribed 2-drug SOC immunosuppression and have a single infusion of expanded Tregs (TRK-001) at Day +53 to +67 following living donor kidney transplantation.\n\nAt Month 3 post-transplant, Arm 2 TRACT\u002FMONO subjects will be further randomized to either Arm 2A: TRACT\u002FMONO mTOR or Arm 2B: TRACT\u002FMONO CNI.\n\nSubjects randomized to Arm 2A: TRACT\u002FMONO mTOR who have a normal biopsy and no de novo donor specific antibodies at Month 3 will begin weaning of tacrolimus and will remain on a 1-drug regimen with either everolimus or sirolimus until the end of the trial.",[19],"Biological: Arm 2A: TRACT\u002FMONO mTOR",{"label":21,"type":16,"description":22,"interventionNames":23},"Arm 2B: TRACT\u002FMONO CNI","Arm 2: TRACT\u002FMONO- At the beginning of the trial, subjects randomized to Arm 2 will be maintained on the prescribed 2-drug SOC immunosuppression and have a single infusion of expanded Tregs (TRK-001) at Day +53 to +67 following living donor kidney transplantation.\n\nAt Month 3 post-transplant, Arm 2 TRACT\u002FMONO subjects will be further randomized to either Arm 2A: TRACT\u002FMONO mTOR or Arm 2B: TRACT\u002FMONO CNI.\n\nSubjects randomized to Arm 2B: TRACT\u002FMONO CNI who have a normal biopsy and no de novo donor specific antibodies at Month 3 will begin weaning of the mTOR medication and will remain on a 1-drug regimen with low dose tacrolimus until the end of the trial.",[24],"Biological: Arm 2B: TRACT\u002FMONO CNI",[26,33,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Arm 1: SOC (mTOR + CNI)","Subjects randomized to Arm 1 will remain on standard dual-immunosuppression therapy (CNI and mTOR) throughout the trial.",[9],[32],"sirolimus or everolimus + tacrolimus",{"type":34,"name":15,"description":35,"armGroupLabels":36,"otherNames":37},"BIOLOGICAL","All subjects will be prescribed standard of care (SOC) immunosuppressive agents. Subjects randomized to Arm 2 will be maintained on the prescribed SOC immunosuppression (tacrolimus + sirolimus or everolimus) and have a single intravenous infusion of autologous, expanded Tregs (TRK-001) at Day +53 to +67 post-transplant. At Month 3 post-transplant, Arm 2 subjects will be further randomized to receive either:\n\n* Arm 2A: mTOR monotherapy or\n* Arm 2B: CNI monotherapy.\n\nThese subjects will transition to the assigned 1-drug immunosuppression regimen beginning at Month 3 post-transplant. Weaning must be completed by 12 months post-transplant.\n\nSubjects in Arm 2 will undergo leukapheresis to collect peripheral blood mononuclear cells required for the cellular product.",[15],[38],"TRK-001 + sirolimus or everolimus",{"type":34,"name":21,"description":35,"armGroupLabels":40,"otherNames":41},[21],[42],"TRK-001 + tacrolimus",null,[45,50],{"name":46,"role":47,"phone":48,"phoneExt":43,"email":49},"Susan B Murray","CONTACT","+1-312-219-4670","susan.murray@singulera-tx.com",{"name":51,"role":47,"phone":52,"phoneExt":43,"email":53},"Erwin Teng","+886-931-392700","erwin.teng@twbio-thera.com",[55,73,86,99,113,126,138],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Mayo Clinic in Arizona","RECRUITING","Phoenix","Arizona","85054","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-112.07404,33.44838,{"lat":67,"lon":66},[70],{"name":71,"role":72,"phone":43,"phoneExt":43,"email":43},"Girish Mour, M.B.B.S.","PRINCIPAL_INVESTIGATOR",{"facility":74,"status":57,"city":75,"state":76,"zip":77,"country":61,"countryCode":62,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Northwestern Memorial Hospital","Chicago","Illinois","60611",{"type":64,"coordinates":79},[80,81],-87.65005,41.85003,{"lat":81,"lon":80},[84],{"name":85,"role":72,"phone":43,"phoneExt":43,"email":43},"M. Javeed Ansari, MD, MRCP",{"facility":87,"status":57,"city":88,"state":89,"zip":90,"country":61,"countryCode":62,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Mayo Clinic in Minnesota","Rochester","Minnesota","55905",{"type":64,"coordinates":92},[93,94],-92.4699,44.02163,{"lat":94,"lon":93},[97],{"name":98,"role":72,"phone":43,"phoneExt":43,"email":43},"Nikolaos Skartsis, M.D., Ph.D.",{"facility":100,"status":57,"city":101,"state":43,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Taichung Veterans General Hospital","Taichung","407219","Taiwan","TW",{"type":64,"coordinates":106},[107,108],120.6839,24.1469,{"lat":108,"lon":107},[111],{"name":112,"role":72,"phone":43,"phoneExt":43,"email":43},"Cheng-Hsu Chen, MD, PhD",{"facility":114,"status":115,"city":116,"state":43,"zip":117,"country":103,"countryCode":104,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"National Cheng Kung University Hospital","NOT_YET_RECRUITING","Tainan","704",{"type":64,"coordinates":119},[120,121],120.21333,22.99083,{"lat":121,"lon":120},[124],{"name":125,"role":72,"phone":43,"phoneExt":43,"email":43},"Shen-Shin Chang, MD",{"facility":127,"status":57,"city":128,"state":43,"zip":129,"country":103,"countryCode":104,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"National Taiwan University Hospital","Taipei","100229",{"type":64,"coordinates":131},[132,133],121.52639,25.05306,{"lat":133,"lon":132},[136],{"name":137,"role":72,"phone":43,"phoneExt":43,"email":43},"Chih-Yuan Lee, MD, PhD",{"facility":139,"status":57,"city":140,"state":43,"zip":141,"country":103,"countryCode":104,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Chang Gung Medical Foundation Hospital","Taoyuan","333",{"type":64,"coordinates":143},[144,145],121.29696,24.99368,{"lat":145,"lon":144},[148],{"name":149,"role":72,"phone":43,"phoneExt":43,"email":43},"Huang-Yu Yang, MD, PhD",{"type":151,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[153],{"name":154,"class":6},"Taiwan Bio Therapeutics Inc.","100558519","phase-2-regulatory-t-cell-therapy-to-achieve-immunosuppression-reduction-100558519",false,"NCT06552169","REgulatory T Cell Therapy to Achieve Immunosuppression REduction","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","RETIRE","Inclusion Criteria\n\nAll inclusion criteria must be met prior to randomization.\n\n1. Males or females aged 18-65 years as of the date of informed consent who will undergo a single organ, living donor kidney transplant.\n2. 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.\n3. Blood type compatibility between recipient and donor must be established as follows.\n\n   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.\n4. No prior organ transplant of any kind.\n5. 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.\n6. 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.\n7. Subjects (recipients) must be able to understand the consent form and give written informed consent prior to any trial procedure.\n8. If donor informed consent is required by IRB\u002FIEC, 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.\n\nExclusion Criteria Based on SOC Pre-Transplant Evaluation\n\nThe following exclusion criteria must be determined prior to randomization per SOC pre-transplant evaluation.\n\n1. Known sensitivity or contraindication to thymoglobulin, everolimus, sirolimus, or tacrolimus or other immunosuppression medication prescribed.\n2. Subjects with a positive crossmatch by virtual cross matching or complement-dependent cytotoxicity (CDC) cross matching or flow cytometry cross matching (FCXM).\n3. 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.\n4. Subjects with current or historic donor specific antibodies.\n5. Body Mass Index (BMI) of \\\u003C 16 kg\u002Fm2 or \\> 38 kg\u002Fm2 per SOC pre-transplant evaluation.\n6. Subjects who are pregnant or nursing mothers.\n7. Subjects whose life expectancy is severely limited by diseases other than renal disease, per judgement of an investigator.\n8. Ongoing active drug or alcohol substance abuse, per judgement of an investigator.\n9. Major ongoing psychiatric illness or recent history of noncompliance with current medical therapy, per judgement of an investigator.\n10. Significant cardiovascular disease (e.g.):\n\n    * Significant non-correctable coronary artery disease, per judgement of an investigator\n    * Ejection fraction below 30% per SOC echocardiogram if an echocardiogram is performed for an individual subject as part of their pre-transplant evaluation\n    * History of recent (\\\u003C 12 months) myocardial infarction at time of informed consent\n    * History of recent (within 3 months) vascular intervention(s) for coronary artery disease at the time of informed consent\n    * Documented arrhythmias that require a pacemaker or medical therapy for control.\n11. Subjects who require use of chronic anticoagulation medications. Use of anti-platelet medications will be allowed in absence of a documented arrhythmia.\n12. Malignancy within 3 years, excluding non-melanoma skin cancers such as basal cell carcinoma and squamous cell carcinoma.\n13. Serologic evidence of active infection with HCV, HIV or HBV per SOC pre-transplant evaluation. Historical data within three months of transplant are acceptable.\n14. Subjects with a total white blood cell count \\\u003C 4,000\u002Fmm3; platelet count \\\u003C 50,000\u002Fmm3; triglyceride \\> 400 mg\u002FdL; total cholesterol \\> 300 mg\u002FdL, prothrombin time \\\u003C8.4 seconds or \\>15.7 seconds, activated partial thromboplastin time \\\u003C21.6 or \\> 42.3 seconds, fibrinogen \\\u003C177 mg\u002FdL or \\>598 mg\u002FdL, and INR \\\u003C0.64 or \\>1.4.\n15. Subjects with underlying renal disease etiologies with high risk of disease recurrence such as primary focal segmental glomerulosclerosis and others per investigator discretion.\n16. 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.\n17. Diabetic subjects with an HbA1c of \\>8%.\n\n    The following exclusion criteria must be determined prior to transplant per SOC pre-transplant evaluation.\n18. Subjects with an active infection considered clinically significant by an investigator that has not resolved prior to transplant.\n\nExclusion Criteria Prior to Leukapheresis (Arm 2)\n\n1. Subjects with an active infection considered clinically significant by an investigator that has not resolved prior to leukapheresis.\n2. 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).\n3. Subjects who are pregnant or nursing.\n4. Subjects who received an investigational drug within 30 days prior to leukapheresis.\n5. Subjects who received anti-T cell therapy within 30 days prior to leukapheresis.\n6. Subjects who do not meet pre-leukapheresis clearance parameters per institutional practices or per investigator discretion.\n\nExclusion Criteria Prior to TRACT Cellular Product Infusion (Arm 2)\n\n1. Subjects with an active infection considered clinically significant by the investigator that has not resolved prior to planned Treg infusion.\n2. Subjects with a new, clinically significant medical condition that, per investigator opinion, would impact the ability to safely administer TRK-001.\n3. Subjects who experience a rejection episode of the kidney graft prior to the planned Treg infusion.\n4. 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.\n5. Subjects who received an investigational drug within 30 days prior to infusion.\n6. Subjects who received anti-T cell therapy within 30 days prior to infusion.","ALL","18 Years","65 Years",{"count":167,"type":168},34,"ESTIMATED","INTERVENTIONAL",[171],"PHASE2","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.\n\nEnrolled subjects will be randomized to one of 2 study arms:\n\nArm 1 subjects will receive standard of care immunosuppression\n\nArm 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.\n\nThe 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.\n\nAll enrolled subjects will be followed for 5 years post-transplant.",[174],"Kidney Transplantation",[176,177,174,178,179,180,181,182,183],"Regulatory T cells","Treg adoptive cell transfer (TRACT)","Graft Rejection","Autologous cell therapy","End stage renal disease","Prevention of organ transplant rejection","Tregs","Reduced immunosuppression","2026-04-22",{"date":186,"type":187},"2026-04-27","ACTUAL",{"date":189,"type":187},"2025-06-13",{"date":191,"type":168},"2031-12",{"name":5,"class":6},7]