(CTOTC-12/ ARTEMIS) Safety of Donor Alloantigen Reactive Tregs to Facilitate Minimization and/or Discontinuation of Immunosuppression in Adult Liver Transplant Recipients

Project: Research project

Project Details

Description

Study Objectives
2.1 Primary Safety Objective: darTregs Infusion
This study will evaluate the safety and tolerability of a single infusion of donor alloantigen reactive regulatory T cells (darTregs) in adult LT recipients.
2.1.1 Secondary Safety Objective: IS Withdrawal
This study will evaluate the safety of IS 1) reduction and 2) discontinuation after one IV dose of darTregs.
2.2 Primary Efficacy Objective: IS Minimization
The study will evaluate the ability of a single IV dose of darTregs to reduce baseline, standard of care (SOC) CNI dose by 75% along with discontinuation of either prednisone or mycophenolate mofetil (MMF), as applicable.
2.3 Secondary Efficacy Objective: Tolerance
This study will determine the number and proportion of LT recipients who become operationally tolerant with darTregs infusion. We hypothesize that a single dose of darTregs in a well-defined cohort of LT recipients will induce operational tolerance as revealed by subsequent IS withdrawal.
2.4 Mechanistic Objectives
We will assess the pharmacokinetic profile of darTregs by measuring the level of deuterium-labeled darTregs in circulation and in biopsies. Potential impact of darTregs therapy on immunological profiles will be assessed by comparing leukocyte phenotypes and tissue histology in protocol and for-cause biopsies, and alloantibody before and after darTregs infusion.
StatusFinished
Effective start/end date2/1/161/31/20

Funding

  • University of California, San Francisco (9320sc//5U01AI104347-05 REVISED)
  • National Institute of Allergy and Infectious Diseases (9320sc//5U01AI104347-05 REVISED)

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