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NCT Number: NCT07251179

Characterization of Autoreactive b Lymphocytes in Autoimmune Diseases and Immune Deficiencies

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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Key information

Conditions

Systemic Lupus Erythematosus ANCA-associated Vasculitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Antiphospholipid Syndrome Autoimmune Diseases Cardiovascular Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Primary Immunodeficiencies Scleroderma, Systemic Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Scleroderma Systemic Vasculitis Vascular Diseases Vasculitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location status: Recruiting

Location contact

Anne-Sophie KORGANOW, MD

CONTACT

[email protected]

+33369551123 ext. 0033

Anne-Sophie KORGANOW, MD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Draw

Biological

blood draw

Primary outcomes

Study of the percentage of autoreactive LB / tetrameric LB+

Time frame: inclusion visit

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Sophie KORGANOW, MD

CONTACT

[email protected]

03 69 55 09 94 ext. 0033

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: AutoB-Tetramer

Important dates

Study start: 2026
Primary completion: 2031
Study completion: 2031
First posted: Nov 26, 2025
Registry last updated: Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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