NCT07251179Recruiting
Characterization of Autoreactive b Lymphocytes in Autoimmune Diseases and Immune Deficiencies
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
Autoimmune diseases (AID), whether systemic or organ-specific, affect approximately one in ten people, and their prevalence continues to increase. Many AIDs are linked to the emergence of autoreactive B cells (BCs) directed against components of the self. In healthy individuals, these autoreactive B cells are counter-selected or regulated before reaching the antibody-secreting cell compartment. However, in predisposed individuals, a breakdown in B cell tolerance can occur, leading to the formation of autoantibodies with devastating consequences, such as the emergence of systemic lupus erythematosus (SLE), rheumatoid arthritis, and vasculitis. B-cell depletion is often beneficial in these patients, but paradoxically, therapies targeting B cells are not always effective. Furthermore, B cell depletion via LB-specific antibodies (anti-CD20) or treatment with CD19 chimeric antigen receptor T cells (CAR T) leads to complete and prolonged depression of the entire B compartment without targeting the LB population responsible for the onset of the disease. To date, two pitfalls in studies of human autoreactive LBs often complicate the interpretation of results: i) the difficulty of identifying autoreactive LBs among all LBs, ii) demonstrating the pathogenicity of autoreactive B lymphocytes when they can be identified individually. We propose to quantify and phenotype these autoreactive/pathogenic B cells using high-throughput flow cytometry in several clinical situations.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 18 Nov 2025
- Start date
- 20 Jan 2026
- Primary completion date
- 31 Dec 2031
- Lead sponsor
- University Hospital, Strasbourg, France
- NCT number
- NCT07251179
What you commit to
- Study type: Observational
- Planned participants: 200
- From 20 Jan 2026 to the primary completion date, 31 Dec 2031
- 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
- Patient in a period of exclusion (determined by a previous or ongoing study) Inability to provide the subject with informed consent (in an emergency or immediate life-threatening situation, difficulties in understanding the subject, etc.)
Other
- Patient refusing to participate in the study
- Patient under legal protection
- Patient under guardianship or conservatorship
Who the study is looking for
- Patients aged between 18 and 70
- Patients for whom at least one of the following conditions has been confirmed:
- Systemic lupus erythematosus meeting the 2019 ACR/EULAR classification criteria.
- Systemic scleroderma meeting the 2013 ACR/EULAR classification criteria. ANCA-associated vasculitis according to the 2022 EULAR/ACR classification criteria.
- Antiphospholipid syndrome according to the 2023 ACR/EULAR criteria.
- Primary immunodeficiencies according to IUIS criteria.
- Patients capable of understanding the objectives of the research.
- Patients affiliated with a social security health insurance scheme (beneficiary or dependant).
- Patients who have signed and dated the informed consent form for non-identifying genetic testing.
Age in the registry: 18 years to 70 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 |
|---|---|---|---|
| Hopitaux Universitaires de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.