对vibecotamab的第一阶段研究确定了治疗复发性/耐药性急性髓性白血病的最佳剂量
Farhad Ravandi1, Asad Bashey2, James Foran3
1Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.
Blood advances
|August 30, 2023
概括
维贝科他马布是一种新型双特异性抗体,通过向CD123+细胞来治疗急性髓性白血病 (AML) 是有前途的. 第一阶段研究确定了安全性,并确定了推剂量,一些患者实现了缓解.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 血液学 血液学 血液学
背景情况:
- 急性髓性白血病 (AML) 是一种具有有限治疗选择的侵袭性癌症.
- CD123是AML治疗的有希望的标,因为它在白血病细胞上表达.
- 免疫疗法提供了一种通过利用免疫系统来对抗AML的新方法.
研究的目的:
- 评估vibecotamab (XmAb14045) 在复发/耐药AML患者的安全性和耐受性.
- 为了确定vibecotamab的最大耐受剂量 (MTD) 和推的第二阶段剂量 (RP2D).
- 评估vibecotamab在表达CD123的AML的患者中的初步疗效.
主要方法:
- 一个第一阶段,对vibecotamab的剂量升级研究,这是一个针对CD3和CD123.3的双特异抗体.
- 患者接受了逐步增加剂量的治疗,随后每周给予vibecotamab.
- 对包括细胞因子释放综合征 (CRS) 在内的不良事件进行了监测. 通过总体反应率 (ORR) 评估有效性.
主要成果:
- 维贝科他马布一般耐受性很好,CRS是最常见的不良事件,大多是可以管理的.
- 在120名患者中,16名患者观察到剂量限制性毒性.
- 在可评估疗效的患者中观察到总体应答率 (ORR) 为9.0%,在剂量≥0.75μg/kg时应答率更高.
结论:
- 维贝科他马布在复发性/耐药性AML中显示出可接受的安全性和初步疗效.
- 该研究确定了vibecotamab的推第二阶段剂量.
- 需要在更大的试验中进行进一步的研究,以确认vibecotamab在AML中的治疗潜力.
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