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BETA prime:对AdAPT-001进行首次人体第一阶段研究,这是一种针对固体瘤的武装瘤性腺病毒

Anthony P Conley¹, Christina L Roland¹, Alberto Bessudo²

¹Department of Sarcoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.

Cancer gene therapy

|December 25, 2023

概括

一种瘤性腺病毒AdAPT-001在先进的固体瘤中显示出良好的安全性和有效性. 推剂量为1.0×10^12个病毒颗粒,每两周注入口内注射一次.

科学领域:

瘤治疗性病毒疗法
癌症免疫疗法癌症免疫疗法
瘤微环境调制

背景情况:

转化生长因子β (TGF-β) 是一种免疫抑制性细胞因子.
瘤性腺病毒 (OAV) 是一种工程病毒,可以选择性地感染和杀死癌细胞.
AdAPT-001是一种OAV,设计具有TGF-β陷,以中和其免疫抑制作用.

研究的目的:

评估AdAPT-001在患有晚期固体瘤的患者的安全性和耐受性.
评估AdAPT-001作为单次内注射 (第1部分) 和多剂量内注射 (第2部分) 的疗效.
为了确定AdAPT-001.001的推第二阶段剂量.

主要方法:

第1期,剂量升级研究 (第1部分) 在9名患者中进行,患者服用不同剂量的AdAPT-001.
在接受AdAPT-001治疗的19名患者中,剂量扩展阶段 (第二部分) 处于1.0×10^12病毒颗粒 (vps) 的水平.
用AdAPT-001进行内注射,有效性根据RECIST 1.1标准进行评估.

主要成果:

在第1部分中没有观察到剂量限制性毒性或与治疗相关的严重不良事件.
在第2部分,确认了3名患者的部分反应和5名患者的持久稳定疾病 (≥6个月).
在注射和未注射的病变中,AdAPT-001显示出抗瘤作用.
推的第二阶段剂量是1.0×10^12vps,每两周内服.

结论:

AdAPT-001耐受性良好,在先进的固体瘤中显示出有前途的抗瘤活性.
推的AdAPT-001第二阶段剂量为1.0×10^12vps,每两周注射一次.
目前正在接受AdAPT-001和检查点抑制剂的联合治疗.

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