Characterization of Autoreactive b Lymphocytes in Autoimmune Diseases and Immune Deficiencies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2031-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Systemic Lupus Erythematosus Systemic Scleroderma ANCA-associated Vasculitis Antiphospholipid Syndrome Primary Immunodeficiencies

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Systemic lupus erythematosus

blood draw

Intervention Type BIOLOGICAL

blood draw

Systemic scleroderma

blood draw

Intervention Type BIOLOGICAL

blood draw

ANCA-associated vasculitis

blood draw

Intervention Type BIOLOGICAL

blood draw

Antiphospholipid syndrome

blood draw

Intervention Type BIOLOGICAL

blood draw

Primary immunodeficiencies

blood draw

Intervention Type BIOLOGICAL

blood draw

Interventions

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blood draw

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Patient refusing to participate in the study
* 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.)
* Patient under legal protection
* Patient under guardianship or conservatorship

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No