在患有B细胞急性淋巴细胞白血病的成年人中使用Obecabtagene Autoleucel
Claire Roddie1, Karamjeet S Sandhu1, Eleni Tholouli1
1From the Cancer Institute, University College London (C.R., K.S.P., M.P.), University College London Hospitals NHS Foundation Trust (C.R.), King's College Hospital NHS Foundation Trust (D.Y.), and Autolus Therapeutics (P.L.-S., Y.Z., W.B., E.B., M.P.), London, Manchester Royal Infirmary, Manchester (E.T.), University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.C.), University Hospitals Bristol NHS Foundation Trust, Bristol (K.H.), Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle (T.M.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (R.M.) - all in the United Kingdom; City of Hope National Medical Center, Duarte (K.S.S.), the Hematology, Blood and Marrow Transplant, and Cellular Therapy Program, University of California, San Francisco, San Francisco (A.C.L.), and UC Davis Medical Center, Sacramento (M.A.) - all in California; the Sarah Cannon Transplant and Cellular Therapy Program, Methodist Hospital, San Antonio (P.S.), and the University of Texas M.D. Anderson Cancer Center, Houston (E.J.) - both in Texas; Hospital Universitari Vall d'Hebron-Universitat Autónoma de Barcelona, Barcelona (P.B.), and Hospital Universitari i Politècnic La Fe, Valencia (M.G.) - both in Spain; Washington University School of Medicine, St. Louis (A.G.); the Sarah Cannon Transplant and Cellular Therapy Program, TriStar Centennial Medical Center, Nashville (J.M.P.); the University of Maryland Medical Center, Baltimore (J.A.Y.); Miller School of Medicine, University of Miami, Miami (A.M.B.), and Moffitt Cancer Center, Tampa (B.D.S.) - both in Florida; Winship Cancer Institute of Emory University, Atlanta (M.L.A.); Colorado Blood Cancer Institute, Denver (L.M.); the University of Rochester Medical Center, Rochester (K.M.O.), and Memorial Sloan Kettering Cancer Center, New York (J.H.P.) - both in New York; the David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (M.R.B.); and Dana-Farber Cancer Institute, Boston (D.J.D.).
在患有复发性或耐药性B细胞急性淋巴细胞白血病 (ALL) 的成年人中,Obecabtagene自杀细胞 (obe-cel) 显示出高持久缓解率. 这种仿真抗原受体 (CAR) T细胞疗法显示,严重的免疫相关毒性影响的发病率很低.
科学领域:
- 血液学 血液学 血液学
- 免疫治疗是一种免疫疗法.
- 在瘤学瘤学.
背景情况:
- 奥贝卡巴基因自细胞 (obe-cel) 是一种先进的自41BB-ζ抗CD19仿真抗原受体 (CAR) T细胞疗法.
- 它使用中间亲和度CAR设计来减轻毒性并增强治疗持久性.
- 这种方法针对复发或耐药的B细胞急性淋巴细胞白血病 (ALL).
研究的目的:
- 评估obe-cel在患有复发或耐性B细胞ALL的成年人中的安全性和有效性.
- 主要终点:形态疾病患者的整体缓解率 (2A队列).
- 二级终点:无事件生存率,总生存率和安全性概况.
主要方法:
- 一项1b-2期多中心研究招募了153名患有复发或耐药B细胞ALL的成年患者.
- 患者被分为队列2A (形态疾病) 和队列2B (可测量的残留疾病).
- 评估整体缓解,无事件存活率,整体存活率和不良事件发生率.
主要成果:
- 在接受obe-cel的127名可评估患者中,77%的患者在2A队列中实现了整体缓解 (P<0.001).
- 平均无事件生存时间为11.9个月;平均整体生存时间为15.6个月.
- 3级+细胞因子释放综合征发生在2.4%的患者中,3级+神经毒性发生在7.1%的患者中.
结论:
- 在患有复发性/耐药性B细胞ALL的成年人中,Obe-cel实现了高持久反应率.
- 治疗表明严重的 (3级+) 免疫相关毒性影响的发病率很低.
- 研究结果支持obe-cel作为这个患者群体的有前途的治疗选择.
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