Characterization of Autoreactive b Lymphocytes in Autoimmune Diseases and Immune Deficiencies

NCT07251179 | Not Yet Recruiting

• 1 other identifier: 9942
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Study of the percentage of autoreactive LB / tetrameric LB+

  inclusion visit

Study Arms (5)

Systemic lupus erythematosus

Biological: blood draw

Systemic scleroderma

Biological: blood draw

ANCA-associated vasculitis

Biological: blood draw

Antiphospholipid syndrome

Biological: blood draw

Primary immunodeficiencies

Biological: blood draw

Interventions

blood draw BIOLOGICAL

blood draw

ANCA-associated vasculitis; Antiphospholipid syndrome; Primary immunodeficiencies; Systemic lupus erythematosus; Systemic scleroderma

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hôpitaux Universitaires de Strasbourg

You may qualify if:

• 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.

You may not qualify if:

• Patient refusing to participate in the study
• Patient under legal protection
• Patient under guardianship or conservatorship

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Scleroderma, Systemic; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Antiphospholipid Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Anne-Sophie KORGANOW, MD

CONTACT

03 69 55 09 94; anne-sophie.korganow@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

FR (1)