在复发性或耐药性慢性移植对宿主疾病中使用axatilimab
Daniel Wolff1, Corey Cutler1, Stephanie J Lee1
1From University Hospital Regensburg, Regensburg, Germany (D.W.); Dana-Farber Cancer Institute and Harvard Medical School (C.C.) and Massachusetts General Hospital (Z.D.), Boston, and Syndax Pharmaceuticals, Waltham (V.R., T.O., P.O.) - all in Massachusetts; Fred Hutchinson Cancer Center, Seattle (S.J.L.); Washington University School of Medicine, St. Louis (I.P.); Centre Hospitalier Universitaire Sainte-Justine, Montreal (H.B.), and the University of British Columbia, Vancouver General Hospital, Vancouver (J.W.) - both in Canada; the Medical College of Wisconsin, Milwaukee (M.H., S.C.); Stanford Health Care, Stanford (S.A.), and City of Hope Medical Center, Duarte (A.S.) - both in California; Hospital Universitario Virgen del Rocío Instituto de Biomedicina de Sevilla (IBiS), CSIC, Universidad de Sevilla, Seville (J.A.P.-S.), Hospital General Universitario Gregorio Marañón, Instituto de Investigación Biomédica Gregorio Marañón, and Universidad Complutense de Madrid, Madrid (M.K.), and Hospital Universitario Marqués de Valdecilla (IDIVAL), University of Cantabria, Santander (A.B.) - all in Spain; the M.D. Anderson Cancer Center, Houston (A.A.); the James Cancer Hospital and Solove Research Institute and Ohio State University Wexner Medical Center, Columbus (H.C.); Seoul National University College of Internal Medicine, Seoul, South Korea (I.K.); Hôpital Saint-Louis and University Paris Cité, Paris (G.S.); Incyte Corporation, Wilmington, DE (C.T.); and Vanderbilt University Medical Center, Nashville (C.L.K.).
阿克萨提利马布通过向殖民地刺激因子1受体 (CSF1R) 有效地治疗慢性移植对宿主疾病 (GVHD). 这项研究表明,在患有复发性或耐药性慢性GVHD的患者中,反应率很有希望.
科学领域:
- 免疫学 免疫学 免疫学
- 血液学 血液学 血液学
- 在瘤学瘤学.
背景情况:
- 殖民地刺激因子1受体 (CSF1R) 依赖的单细胞和巨细胞介导慢性移植对宿主疾病 (GVHD).
- 慢性GVHD是所有原性造血干细胞移植后的一个显著并发症.
- 一种阻断CSF1R的抗体Axatilimab在治疗慢性GVHD方面显示出潜在的潜力.
研究的目的:
- 评估三种不同剂量的阿克萨提利马布在患有复发性或耐药性慢性GVHD的患者中的疗效和安全性.
- 评估整体反应率和患者报告的症状负担.
- 为了确定这个患者群体中axatilimab的最佳剂量方案.
主要方法:
- 一项多国,随机的第二阶段研究,涉及241名患有复发性或耐药性慢性GVHD的患者.
- 患者接受了axatilimab静脉注射,剂量为每2周0.3 mg/kg,每2周1 mg/kg或每4周3 mg/kg.
- 主要终点:在前六个周期内总体响应率. 二级终点:使用修改后的李症状量表来减少症状负担.
主要成果:
- 所有剂量组都达到主要终点,总体应答率为74% (0.3毫克/千克),67% (1毫克/千克) 和50% (3毫克/千克).
- 患者报告的症状负担减少在60% (0.3毫克/千克),69% (1毫克/千克) 和41% (3毫克/千克) 的患者中观察到.
- 副作用通常是剂量依赖的短暂实验室异常;停药率因剂量而异 (6%22%).
结论:
- 阿克萨利利马布在患有复发性或耐药性慢性GVHD的患者中表现出显著的临床活性.
- 用axatilimab准CSF1R导致响应的发生率很高.
- 对最佳剂量和长期结果的进一步研究是有必要的.
更多相关视频
06:08Assessment of Chimeric Antigen Receptor T Cell-Associated Toxicities Using an Acute Lymphoblastic Leukemia Patient-Derived Xenograft Mouse Model
Published on: February 10, 2023
06:51Manufacturing Chimeric Antigen Receptor CAR T Cells for Adoptive Immunotherapy
Published on: December 17, 2019
![Dynamic Imaging of Chimeric Antigen Receptor T Cells with [18F]Tetrafluoroborate Positron Emission Tomography/Computed Tomography](/_next/image?url=https%3A%2F%2Fcloudfront.jove.com%2FCDNSource%2Fteasers%2F62334.jpg&w=3840&q=50)