冷凝集素病

定义 英文原文（暂无中文）

Cold agglutinin disease is a type of autoimmune hemolytic anemia defined by the presence of cold autoantibodies (autoantibodies which are active at temperatures below 30°C).

别名

慢性冷凝集素病

基本事实

遗传方式

多基因/多因素

发病年龄

成年期

患病率

1-9 / 1 000 000（Europe）

临床表型 14

近两年的全球研究 305L2

2024/08 起在 Europe PMC 检索所得，按发表时间倒序显示最近 20 篇。标题未译成中文——自动翻译需要接入 LLM 服务，尚未引入。

• 2026-08
  Treatment of Cold Agglutinin Syndrome Secondary to Chronic Lymphocytic Leukemia With Sutimlimab and Obinutuzumab-Venetoclax
  Case reports in hematology · DOI · Europe PMC
• 2026-08综述病例报告
  Temperature Safeguards and Peri-Procedural Strategies for Stem Cell Collection in Cold Agglutinin Disease: A Case Report and Literature Review
  Journal of clinical apheresis · DOI · Europe PMC
• 2026-07
  Bullous Pemphigoid Associated With Cold Agglutinin Disease: Circuit Clotting During Selective Plasma Exchange Resolved by Switching to Double Filtration Plasmapheresis
  The Journal of dermatology · DOI · Europe PMC
• 2026-07
  Standardized diagnostic approach for cold agglutinin disease: results from a Delphi-Based Expert Consensus
  Blood transfusion = Trasfusione del sangue · DOI · Europe PMC
• 2026-07综述
  Sutimlimab for cold agglutinin disease: an updated perspective from approval to real-world clinical treatment
  Expert review of hematology · DOI · Europe PMC
• 2026-07病例报告
  Navigating boundaries of autoimmunity in rare anemias: anti-erythropoietin antibody-mediated pure red cell aplasia in a patient with cold agglutinin disease
  Blood transfusion = Trasfusione del sangue · DOI · Europe PMC
• 2026-07开放获取
  Bioorthogonal tuning of nanosurface opsonisation <i>via</i> click coupling of a complement fusion protein inhibitor
  Chemical communications (Cambridge, England) · DOI · Europe PMC
• 2026-06病例报告开放获取
  Cold agglutinin syndrome secondary to Epstein-Barr virus reactivation during corticosteroid therapy for minimal change nephrotic syndrome in a patient with human immunodeficiency virus infection
  CEN case reports · DOI · Europe PMC
• 2026-06开放获取
  Cold Agglutinin Disease-Like Genetic Signatures in Lymphoplasmacytic Lymphoma-Like Cases Challenge the WHO Fifth Edition Classification
  EJHaem · DOI · Europe PMC
• 2026-06病例报告开放获取
  Warm Autoimmune Hemolytic Anemia Presenting 21 Years After Liver Transplantation: A Case Report
  The American journal of case reports · DOI · Europe PMC
• 2026-06开放获取
  EHA Guidelines on management of chronic lymphocytic leukemia and Richter transformation
  HemaSphere · 被引 3 · DOI · Europe PMC
• 2026-06开放获取
  Scalp cooling outcomes in patients receiving trastuzumab deruxtecan for metastatic breast cancer
  ESMO open · DOI · Europe PMC
• 2026-06病例报告
  Warm autoimmune hemolytic anemia following definitive chemoradiotherapy for cervical cancer: A case report
  Oncology letters · DOI · Europe PMC
• 2026-06综述开放获取
  Decoding Waldenström Macroglobulinemia Through Genomics, Epigenomics and Cellular Interactions
  International journal of molecular sciences
• 2026-06综述开放获取
  Shifting From Systemic to Precision-Targeted Complement Therapies: Opportunities and Hurdles
  European journal of immunology · DOI · Europe PMC
• 2026-06开放获取
  Publication Only
  HemaSphere
• 2026-06综述
  Sutimlimab vs B-cell-targeted therapy in cold agglutinin disease: which is the optimal approach?
  Blood · DOI · Europe PMC
• 2026-06
  Their Blood Ran Cold: A Case Series On Cold Agglutinin Disease
  QJM : monthly journal of the Association of Physicians · DOI · Europe PMC
• 2026-05开放获取
  Commentary: Rituximab combined with lenalidomide for the treatment of marginal zone lymphoma with IgM kappa positivity and cold agglutinin syndrome: a case report
  Frontiers in immunology · DOI · Europe PMC
• 2026-05病例报告开放获取
  Three Faces of Self-Destruction: A Case Series of Warm, Cold, and Mixed Autoimmune Hemolytic Anemia
  Cureus · DOI · Europe PMC

境外已获批用于本病的药物 1L2

欧盟 1 项、美国 0 项。同一药物在两地各批一次的，会分别列出。

• Enjaymo欧盟2022-11-15
  sutimlimab
  官方记录

数据来自欧洲药品管理局（EMA）的药品与孤儿药资格公开导出表，以及美国 FDA 孤儿药资格数据库。两边口径不同：欧盟一侧取的是当前状态仍为「已授权」的药品；美国一侧记录的是「曾获批准」这一事实，FDA 的公开表不追踪药物此后是否退市（例如 Relyvrio 于 2024 年撤市，表中仍记为已获批）。请以官方记录页为准。

在中国开展的临床试验 2L2

按病名在 ClinicalTrials.gov 检索、并校验研究中心含中国大陆而来。登记状态不等于现在真的能入组——务必按 NCT 号到原站核实，并与主治医生商量。

登记为可入组 2

• 招募中NCT07019038
  National Longitudinal Cohort of Hematological Diseases- Autoimmune Hemolytic Anemia
  观察性 · 2001/01/01Institute of Hematology & Blood Diseases Hospital, China
  中国研究中心 1 个：Tianjin
• 尚未开始招募NCT06847607
  A Multicenter Prospective Study of Iptacopan in the Treatment of Refractory/Relapsed Autoimmune Hemolytic Anemia (AIHA)
  不适用 · 干预性 · 2025/03/01Bing Han
  中国研究中心 1 个：Beijing

中国境外的在招试验 6L2

CT.gov 报告命中 6 项，此处取回并展示最近的 4 项。

• 尚未开始招募NCT07091370
  Inaticabtagene Autoleucel Injection in the Treatment of Autoimmune Hemolytic Anemia After Three or More Lines of Therapy
  I 期 · 干预性 · 2025/12/27Juventas Cell Therapy Ltd.
• 招募中NCT07083960
  OM336 in Autoimmune Cytopenias
  I 期 · 干预性 · 2025/08/01Lakefront Biotherapeutics West LLC
  澳大利亚
• 招募中NCT05318534
  Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects and Safety, Tolerability, Pharmacokinetics, and Pilot Efficacy Biomarkers in Subjects With Cold Agglutinin Disease
  I 期 · 干预性 · 2022/04/08Gliknik Inc.
  英国
• 招募中NCT05931718
  Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia
  观察性 · 2019/06/01Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  意大利

外部标识与链接