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临床试验/NCT07251179
NCT07251179招募中不适用

Characterization of Autoreactive b Lymphocytes in Autoimmune Diseases and Immune Deficiencies

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
Study of the percentage of autoreactive LB / tetrameric LB+

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Systemic scleroderma

干预措施: blood draw (Biological)

ANCA-associated vasculitis

干预措施: blood draw (Biological)

Antiphospholipid syndrome

干预措施: blood draw (Biological)

Primary immunodeficiencies

干预措施: blood draw (Biological)

Systemic lupus erythematosus

干预措施: blood draw (Biological)

结局指标

主要结局

Study of the percentage of autoreactive LB / tetrameric LB+

时间窗: inclusion visit

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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