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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06427421 on ClinicalTrials.gov