NCT06427421Recruiting
Characterization of Autoreactive Regulatory and Conventional CD4 T Cells in Recent Onset Type 1 Diabetes and Control Individuals
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 16 May 2024
- Start date
- 6 May 2025
- Primary completion date
- May 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Type 1 diabetes
- NCT number
- NCT06427421
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 6 May 2025 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of oral or intravenous corticosteriods in the month prior to blood sampling
- Use of oral or intravenous corticosteriods in the month prior to blood sampling
Other illness
- History of autoimmune or inflammatory disease
Other
- Newly diagnosed T1DM group:
- Contraindication to the use of anaesthetic cream for blood sampling.
- Control group :
- Contraindication to the use of anaesthetic cream for blood sampling
Who the study is looking for
- Newly diagnosed T1DM group:
- Age ≥ 2 years and \< 18 years on day of inclusion;
- Weight ≥ 12 kg;
- Newly diagnosed T1DM, diagnosis defined according to International Society of Pediatric and Adolescent Diabetes (ISPAD) criteria by: hyperglycemia \> 2g/L and/or ketonemia and/or polyuro-polydipsia and/or weight loss ;
- Absence of other associated inflammatory or autoimmune diseases;
- Affiliation with a health insurance scheme or beneficiary (excluding AME);
- Written consent of parental guardians;
- Ability to understand and read French.
- Control group :
- Age ≥ 2 years and \< 18 years on the day of inclusion;
- Weight ≥ 12 kg;
- No personal history of T1DM;
- Affiliation with a health insurance scheme or entitled person (excluding AME);
- Written consent from parental guardians;
- Ability to understand and read French.
Age in the registry: 6 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.