Characterization of Autoreactive Regulatory and Conventional CD4 T Cells in Recent Onset Type 1 Diabetes and Control Individuals
NCT06427421 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2025-11-20
Summary
Type 1 diabetes (T1D) is caused by an autoimmune response leading to the destruction of pancreatic beta cells. The disease association with particular HLA class II alleles, particularly HLA-DQ8, indicates the implication of CD4 T cells in its aetiology. The hypothesis is therefore that T1D starts by the loss of tolerance in autoreactive CD4 T cells. This might result from alterations in conventional autoreactive CD4 T cells (Tcons), which drive disease, or autoreactive regulatory CD4 T cells expressing the transcription factor FOXP3 (Tregs), which normally maintain immune tolerance. The investigators expect that the characterization of HLA-DQ8-restricted Tcons and Tregs in recent onset HLA-DQ8+ T1D patients shall shed light on the molecular mechanisms underpinning T1D development. This knowledge will guide the development of novel cell therapies harnessing the power of genetically engineered Tregs expressing the relevant antigen receptor to restore immune homeostasis upon cell transfer. The ultimate goal is to reach a curative effect
Conditions
Interventions
- BIOLOGICAL
-
Frequency of Treg and Teffs
additionnal blood sampling at inclusion
- BIOLOGICAL
-
Phenotype of Treg and Teffs
additionnal blood sampling at inclusion
- BIOLOGICAL
-
RNA seq analysis
additionnal blood sampling at inclusion
- BIOLOGICAL
-
HLA typing
additionnal blood sampling at inclusion
- BIOLOGICAL
-
beta-cell autoantibody dosage
additionnal blood sampling at inclusion
- BIOLOGICAL
-
Glycated haemoglobin (HbA1C) dosage
additionnal blood sampling at inclusion
- BIOLOGICAL
-
blood glucose dosage
additionnal blood sampling at inclusion
- BIOLOGICAL
-
C-peptide dosage
additionnal blood sampling at inclusion
Sponsors & Collaborators
-
URC-CIC Paris Descartes Necker Cochin
collaborator OTHER -
Assistance Publique - Hôpitaux de Paris
lead OTHER
Principal Investigators
-
Simon FILATREAU, PhD · Institut National de la Santé Et de la Recherche Médicale, France
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-06
- Primary Completion
- 2027-05-31
- Completion
- 2027-05-31
Countries
- France
Study Locations
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