Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552169
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
REgulatory T Cell Therapy to Achieve Immunosuppression REduction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RETIRE
Brief 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
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
Detailed Description:
This is a prospective multi-national multi-center open-label randomized Phase 2 trial to determine the safety and efficacy of administering autologous expanded regulatory T cells TRK-001 to prevent allograft rejection in living donor renal transplant recipients
All subjects will be followed for 5 years post-transplant comprising of a 2-year post-transplant follow-up period and a 3-year surveillance period
Subjects with end-stage renal disease undergoing a living donor kidney transplant will be enrolled into the trial as follows
Arm 1 SOC Standard of care immunosuppression N14
Arm 2 TRACTMONO TRK-001 and initial SOC immunosuppression weaned to monotherapy N20
At Month 3 post-transplant Arm 2 subjects will be further randomized prior to weaning to either mTOR or CNI monotherapy as follows
Arm 2A TRACTMONO mTOR N10 or Arm 2B TRACTMONO CNI N10
All subjects will be followed for 5 years post-transplant comprising of a 2-year post-transplant follow-up period and a 3-year surveillance period
Subjects with end-stage renal disease undergoing a living donor kidney transplant will be enrolled into the trial as follows
Arm 1 SOC Standard of care immunosuppression N14
Arm 2 TRACTMONO TRK-001 and initial SOC immunosuppression weaned to monotherapy N20
At Month 3 post-transplant Arm 2 subjects will be further randomized prior to weaning to either mTOR or CNI monotherapy as follows
Arm 2A TRACTMONO mTOR N10 or Arm 2B TRACTMONO CNI N10
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None