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Area of Science:

  • Immunology
  • Transplantation Medicine
  • Cell Therapy

Background:

  • Promoting immune tolerance to transplanted organs reduces the need for immunosuppressive drugs, lowering risks of mortality and morbidity.
  • Regulatory T cells (Tregs) are crucial for immune tolerance, with preclinical studies demonstrating their therapeutic potential in transplantation.
  • The ARTEMIS trial (NCT02474199) investigated the safety and efficacy of autologous donor alloantigen-reactive Treg (darTreg) therapy in liver transplant recipients.

Purpose of the Study:

  • To evaluate the efficacy of darTreg therapy in enabling calcineurin inhibitor dose reduction by 75% with stable liver function tests in living donor liver transplant recipients.
  • To assess the safety profile of darTreg infusion.
  • To gain mechanistic insights into Treg behavior after liver transplantation.

Main Methods:

  • Phase 1/2 clinical trial involving individuals 2-6 years post-liver transplant.
  • Initiation of immunosuppression withdrawal followed by darTreg infusion in eligible participants.
  • Monitoring of primary efficacy endpoint: 75% calcineurin inhibitor dose reduction with stable liver function tests for 12 weeks.
  • Mechanistic studies to analyze Treg activation, senescence, and donor reactivity.

Main Results:

  • Of 10 participants initiating immunosuppression withdrawal, 5 received darTreg infusions; 4 did not meet manufacturing criteria.
  • No adverse events were associated with darTreg infusion.
  • Two darTreg-infused participants achieved the primary efficacy endpoint.
  • Mechanistic studies indicated generalized Treg activation, senescence, and reduced donor reactivity post-transplant.

Conclusions:

  • The ARTEMIS trial demonstrated the safety of darTreg infusion but an insufficient number of participants were treated to definitively assess efficacy.
  • Mechanistic findings provide valuable insights into Treg dynamics after liver transplantation, potentially guiding future therapeutic strategies.
  • The trial design offers a framework for evaluating Treg-based therapies in transplantation.