Administration of Low-dose IL-2 in Established T1D

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 54
• Participant gender: All

Summary

Randomized, controlled, double blinded, multicenter, phase I/II clinical trial to evaluate the safety of low-dose IL-2 and to test whether low-dose IL-2 can prevent further loss of beta-cell function in patients with established T1D, or even potentially improve ß-cell function in such individuals, when IL-2 is given for one year (primary outcome). Equally important, the study will carefully examine various effects of low-dose IL-2 on the immune system in patients with T1D, including effects on Treg and other cell subsets, and disease-specific autoimmune responses.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jay S. Skyler
• Collaborators: Diabetes Research Institute Foundation; National Institute of Allergy and Infectious Diseases (NIAID); University of California, San Francisco; University of Florida
• Treatments: Aldesleukin

Criteria

Inclusion Criteria:

• 12-21 years of age

• T1D, demonstrated by at least one islet autoantibody

• T1D duration 4-12 months at the time of the first dose

• Peak stimulated C-peptide >0.2 nmol/L during a 4-hour MMTT

Exclusion Criteria:

• Treatment with oral anti-diabetic agents

• Illnesses that would preclude use of low-dose IL-2