Methodology

Project Information

Grant agreement ID: 101080823
Status: Ongoing project
Overall budget: € 6,998,037.50
Funding: European Union’s Horizon Europe Research and Innovation programme

Start date

July 2023

End date

June 2028

Coordinated by: INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE – France

Work packages

8
European partners

2
Associations involved

more than
8,5

millions of T1D patients worldwide

7
Work Packages

5
Years project

WP1

Human autoreactive Tregs and TCRs in health and T1D

WP2

Humanized T1D models for human antigen-specific Tregs assessment

WP3

Treg supporting strategies in vivo

WP4

GMP-compliant production of antigen-receptor-engineered stable human Treg

WP5

Regulatory and Ethical aspects

WP6

Communication, dissemination and exploitation of results

WP7

Coordination and project management

WP2

Humanized T1D models for human antigen-specific Tregs assessment 

Start: July 2023
End: June 2027

WP leader

Objectives

To demonstrate the effectiveness of the selected TCR and to select the most effective TCR for clinical application using mouse models. Later on, an humanized mouse model will be generated to test the effect of TRC-engineered human Tregs.

WP3

Treg supporting strategies in vivo 

Start: February 2025
End: December 2027

WP leader & Co Leader

Objectives

To improve TCR-engineered Tregs transfer in animals thanks to supported techniques development. Two strategies will be tested separately in order to select the most effective.

WP4

GMP-compliant production of antigen-receptor-engineered stable human Treg

Start: July 2023
End: June 2028

WP leader & Co Leader

Objectives

To obtain a validated, clinical-grade process to use TCR-engineered Tregs in a phase 1 clinical trial for patients with T1D. The primary goal is to gain access to a Good Manufacturing Practice (GMP) compliant process to produce TCR-engineered human Tregs.

WP5

Regulatory and Ethical aspects

Start: July 2023
End: June 2028

WP leader

Objectives

To perform the project (including animal studies) in strict accordance with national and EU regulations. The project will feature 2 transversal WP: WP6 Communication, dissemination and exploitation of results and WP7 Coordination and project management.

WP6

Communication, dissemination and exploitation of results

Start: July 2023
End: June 2028

WP leader

Objectives

To implement a comprehensive communication and dissemination strategy. This will involve the creation of dissemination tools and the establishment of links with patients’ associations. The partners will also develop an appropriate exploitation plan to ensure the protection, application, and further use of the project results.

WP7

Coordination and project management

Start: July 2023
End: June 2028

WP leader & Co Leader

Objectives

To implement an effective management structure to make sure ARTiDe achieves its objectives and impacts.

WP1

Human autoreactive Tregs and TCRs in health and T1D

Start: March 2023
End: December 2027

WP leader

Objectives

To identify potential and promising TCR candidates of Tregs in type 1 diabetic patients. A database will be generated from these experiments which will be analyzed using a machine learning strategy to develop a rational approach for selecting TCRs. At the end of this WP, a small number of TCRs will be selected to be tested in the other WP.