CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
PolyTregs+IL-2biological
Likely dose
PolyTregs+IL-2 106 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02772679
NCT02772679Phase 1Completed
CompareCT.gov

A Phase 1 Trial of CD4+CD127lo/-CD25+ Polyclonal Treg Adoptive Immunotherapy With Interleukin-2 for the Treatment of Type 1 Diabetes

Jeffrey Bluestone·interventional·Posted May 13, 2016·Updated Oct 19, 2021

In Brief

A Phase 1 clinical trial evaluating PolyTregs+IL-2 for Type 1 Diabetes Mellitus. Completed, enrolled 16 participants across 2 sites.

Detailed Summary

The purpose of this study is to assess the safety of Tregs + IL-2 and survival of Tregs in patients with recent onset T1DM who receive infusions of autologous Tregs + IL-2.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsYale University

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 13, 2016
Enrollment StartAug 1, 2016
Primary CompletionAug 27, 2021
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 10.1 years ago

Interventions

PolyTregs+IL-2biological

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.