REgulatory T Cell Therapy to Achieve Immunosuppression REduction
NCT Number: NCT06552169
Acronym: RETIRE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Kidney Transplantation
Interventions: DRUG: Arm 1: SOC (mTOR + CNI)|BIOLOGICAL: Arm 2A: TRACT/MONO mTOR|BIOLOGICAL: Arm 2B: TRACT/MONO CNI
Sponsor: Tract Therapeutics, Inc.
Collaborators: PhiBio Therapeutics Inc|Taiwan Bio Therapeutics Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-12
Completion Date: 2030-12
Locations: Northwestern Memorial Hospital, Chicago, Illinois, 60611, United States|National Taiwan University Hospital - Hsinchu Branch, Hsinchu, 302058, Taiwan|Taichung Veterans General Hospital, Taichung, 407219, Taiwan|National Taiwan University Hospital, Taipei, 100229, Taiwan|Chang Gung Medical Foundation Hospital, Taoyuan, 333, Taiwan

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 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.

Primary Outcome Measures: Development of de novo donor-specific antibodies, A primary outcome measure for this study is to evaluate a composite endpoint of immunologic events against the allograft, where a failure is defined as patient-experienced immunologic events including the development of de novo donor-specific antibodies., Month 12 Post-transplant|Biopsy-proven acute rejection, A primary outcome measure for this study is to evaluate a composite endpoint of immunologic events against the allograft, where a failure is defined as patient-experienced immunologic events including biopsy-proven acute rejection., Month 12 Post-transplant|Biopsy-proven subclinical rejection, A primary outcome measure for this study is to evaluate a composite endpoint of immunologic events against the allograft, where a failure is defined as patient-experienced immunologic events including biopsy-proven subclinical rejection., Month 12 Post-transplant|Development of significant (2+) interstitial fibrosis/tubular atrophy, A primary outcome measure for this study is to evaluate a composite endpoint of immunologic events against the allograft, where a failure is defined as patient-experienced immunologic events including the development of significant (2+) interstitial fibrosis/tubular atrophy., Month 12 Post-transplant|Successful taper to monotherapy (Arm 2), A primary outcome measure for this study is to evaluate the ability for Arm 2 subjects to successfully taper to monotherapy by one-year post-transplant., Month 12 Post-transplant
Secondary Outcome Measures: Successful maintenance of monotherapy (Arm 2), A secondary outcome measure for this study is to evaluate the ability for Arm 2 subjects to successfully maintain monotherapy through two-years post-transplant., Month 24 Post-transplant|Development of de novo donor-specific antibodies, A secondary outcome measure for this study is to evaluate overall and composite component-specific time to immunologic failure where a failure is defined as patient-experienced immunologic events including the development of de novo donor-specific antibodies., To Month 60 Post-transplant|Biopsy-proven acute rejection, A secondary outcome measure for this study is to evaluate overall and composite component-specific time to immunologic failure where a failure is defined as patient-experienced immunologic events including biopsy-proven acute rejection., To Month 60 Post-transplant|Biopsy-proven subclinical rejection, A secondary outcome measure for this study is to evaluate overall and composite component-specific time to immunologic failure where a failure is defined as patient-experienced immunologic events including biopsy-proven subclinical rejection., To Month 60 Post-transplant|Development of significant (2+) interstitial fibrosis/tubular atrophy, A secondary outcome measure for this study is to evaluate overall and composite component-specific time to immunologic failure where a failure is defined as patient-experienced immunologic events including the development of significant (2+) interstitial fibrosis/tubular atrophy., To Month 60 Post-transplant|Graft loss, A secondary outcome measure for the study is the incidence and timing of clinical outcomes, including graft loss. Graft loss is defined as 56 consecutive days of hemodialysis or re-transplantation., To Month 60 Post-transplant|Malignancy, A secondary outcome measure for the study is the incidence and timing of clinical outcomes, including malignancy., To Month 60 Post-transplant|Infections, A secondary outcome measure for the study is the incidence and timing of clinical outcomes, including infections (bacterial, viral, fungal)., To Month 60 Post-transplant|Metabolic anomalies, A secondary outcome measure for the study is the incidence and timing of clinical outcomes, including metabolic anomalies (e.g., diabetes mellitus, metabolic syndrome, hyperthyroidism, hypothyroidism)., To Month 60 Post-transplant|Biopsy-proven acute rejection, A secondary outcome measure for the study is to evaluate the incidence and timing of a composite endpoint of immunologic events against the allograft, where a failure is defined as patient-experienced immunologic event, including biopsy-proven acute rejection., To Month 24 Post-transplant|Graft loss, A secondary outcome measure for the study is to evaluate the incidence and timing of a composite endpoint of immunologic events against the allograft, where a failure is defined as patient-experienced immunologic event, including graft loss. Graft loss is defined as 56 consecutive days of hemodialysis or re-transplantation., To Month 24 Post-transplant|Death (all cause), A secondary outcome measure for the study is to evaluate the incidence and timing of a composite endpoint of immunologic events against the allograft, where a failure is defined as patient- experienced immunologic event, including all cause death., To Month 24 Post-transplant|Quality of Life Measures by using KDQOL-SF, The KDQOL-SF is an assessment tool designed for individuals with kidney disease to measure the impact of kidney disease and its treatment on a patient's quality of life., To Month 60 Post-transplant|Quality of Life Measures by using EQ-5D-5L, The EQ-5D-5L is a standardized measurement tool to evaluate health status. The questionnaire has a descriptive section and a visual analog scale., To Month 60 Post-transplant|Safety- Adverse Events, Incidence of adverse events, To Month 60 Post-transplant