B/BE/18/BVW5 - Summary Notification Information Format (SNIF) Public information presented according to the provisions of Directive 2001/18/EC
Long title
A prospective, multi-center, Phase 1b/2a study to assess the safety and tolerability of different doses of AG019 administered alone or in association with teplizumab in subjects with clinical recent-onset Type 1 Diabetes Mellitus (T1D).
Date receipt dossier
EU record number
B/BE/18/BVW5
EudraCT number
2016-004161-68
Company / Sponsor
Intrexon T1D Partners, LLC
Phase
Ib/II
Treated organism
Humans
Indication category
Metabolic disorders
Disease
Type 1 Diabetes Mellitus (T1D)
Therapeutic approach
Immunotherapy
Genetic modification
Biologically contained strain of Lactococcus lactis, genetically modified to secrete human interleukin-10 and proinsulin
Administered biological material
GM Lactococcus lactis
Route of administration
Oral
Locations in Belgium
UZ Gasthuisberg, Leuven; UZ Brussel; UZ Antwerpen, Edegem
Nr of subjects
The clinical trial will enroll a total of 48 participants. Among these 48 patients, only 10 will be enrolled in Belgium.
Foreseen duration
From 01/08/2018 until 31/08/2019
Type of procedure
Contained use and Deliberate release
Current status
Authorized