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.
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Development of de novo donor-specific antibodies
Timeframe: Month 12 Post-transplant
Biopsy-proven acute rejection
Timeframe: Month 12 Post-transplant
Biopsy-proven subclinical rejection
Timeframe: Month 12 Post-transplant
Development of significant (2+) interstitial fibrosis/tubular atrophy
Timeframe: Month 12 Post-transplant
Successful taper to monotherapy (Arm 2)
Timeframe: Month 12 Post-transplant