REgulatory T Cell Therapy to Achieve Immunosuppression REduction
Status:
RECRUITING
Trial end date:
2031-06-01
Target enrollment:
Participant gender:
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.
Phase:
PHASE2
Details
Lead Sponsor:
Tract Therapeutics, Inc.
Collaborators:
PhiBio Therapeutics Inc Taiwan Bio Therapeutics Inc.