Characterization of Autoreactive b Lymphocytes in Autoimmune Diseases and Immune Deficiencies

Sponsor
University Hospital, Strasbourg, France
Study ID
NCT07251179
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • blood draw — BIOLOGICAL
    blood draw

Study Details

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.

Key Dates

First listed
Nov 26, 2025
Start date
Jan 20, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Systemic lupus erythematosus
  • Arm: Systemic scleroderma
  • Arm: ANCA-associated vasculitis
  • Arm: Antiphospholipid syndrome
  • Arm: Primary immunodeficiencies

Primary Outcome Measure

Study of the percentage of autoreactive LB / tetrameric LB+ [ Time Frame: inclusion visit ]

Central Contacts

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