Dose Finding Study of Il-2 at Ultra-low Dose in Children With Recently Diagnosed Type 1 Diabetes
Status:
Completed
Trial end date:
2017-03-16
Target enrollment:
Participant gender:
Summary
Human recombinant interleukin-2 (rhIL-2) is a biological signalling protein playing a key
role in the regulation of the immune system. At high doses, rhIL-2 activates the immune
effectors T cells (TEFFS) while at low doses rhIL-2 induces and activates regulatory T cells
(TREGS), a population of immune cells controlling the immune Teff response. In patients with
Type 1 Diabetes (T1D), TREGS fail to control the autoimmune destruction by TEFFS of
pancreatic beta-cells producing insulin. The investigator recently showed that rhIL-2 at low
dose is well tolerated in patients with an autoimmune disease and in adults with established
T1D, inducing TREGS without effects on TEFFS. The investigators aim to use rhIL-2 at low dose
to induce/stimulate TREGS in young recently diagnosed T1D patients. This study will
investigate the dose effect relationship of low dose rhIL-2 on TREG induction such as to
optimize the risk benefit ratio of this treatment in T1D. Through Treg induction, the
investigators aim to protect the remaining/regenerating pancreatic β-cells from autoimmune
destruction, thus improving or even curing T1D.