T1DM Immunotherapy Using Polyclonal Tregs + IL-2

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

August 27, 2021

Study Completion Date

August 27, 2021

Conditions
Type 1 Diabetes Mellitus
Interventions
BIOLOGICAL

PolyTregs+IL-2

PolyTregs will be infused into the patient in a single infusion. The first cohort will receive 3 x10\^6 cells. The second cohort will receive 20x10\^6 cells. Following the day 0 infusion of polyclonal Tregs, subjects will receive two 5-day courses of IL-2 (1 x 106 IU daily), the first on days 3-7 and the second on days 38-42. Administration of the second course of IL-2 may be delayed or withheld depending on threshold criteria for peripheral blood Treg frequencies and MMTT-stimulated C-peptide levels determined on day 28.

Trial Locations (2)

94143

University of California, San Francisco Medical Center, San Francisco

06519

Yale University, New Haven

All Listed Sponsors
collaborator

Yale University

OTHER

lead

Jeffrey Bluestone

OTHER

NCT02772679 - T1DM Immunotherapy Using Polyclonal Tregs + IL-2 | Biotech Hunter | Biotech Hunter