Low-dose IL-2 for Treg Expansion and Tolerance (LITE)
Status:
Terminated
Trial end date:
2019-01-31
Target enrollment:
Participant gender:
Summary
Regulatory T cells (Tregs) suppress cytopathic immune responses and inhibit transplant
rejection. Our goal is to exploit the Treg suppressive properties to induce transplantation
tolerance. In contrast to effector T cells, Tregs constitutively express the high affinity
IL-2 receptor, which makes them exquisitely sensitive to very low-doses of IL-2. We propose
here to conduct a phase IV clinical trial in which we will test the capacity of low-dose IL-2
to promote the selective expansion of endogenous Tregs in liver transplant recipients at the
time immunosuppressive drugs are being discontinued. We expect this will promote Treg
accumulation within the transplanted liver, shift the balance between effector T cells and
Tregs, and facilitate the development of operational tolerance in patients unlikely to reach
this state spontaneously. We expect the trial to start shortly after the initiation of the
project and to provide robust evidence on the efficacy of IL-2 within 47 months.