一个国际的,开放的,第二阶段试验,用于高级突肉瘤和myxoid圆细胞脂瘤的afamitresgene自细胞
Sandra P D'Angelo1, Dejka M Araujo2, Albiruni R Abdul Razak3
1Memorial Sloan Kettering Cancer Center, New York, NY, USA; Weill Cornell Medical College, New York, NY, USA.
Lancet (London, England)
|March 30, 2024
概括
在晚期突肉瘤或myxoid圆细胞脂肉瘤患者中,afamitresgene自细胞 (afami- cel) 的整体应答率为37%. 这种T细胞受体疗法对治疗这些罕见的固体瘤具有前景.
科学领域:
- 癌症学
- 免疫疗法
- 细胞疗法
背景情况:
- 在之前的第一阶段试验中,afamitresgene autoleucel (afami- cel) 显示出有前途的安全性和有效性.
- 这项研究旨在进一步评估afami- cel在表达HLA- A*02和MAGE- A4的晚期突肉瘤或myxoid圆细胞脂肪瘤中的疗效.
研究的目的:
- 评估afami- cel在晚期突肉瘤或myxoid圆细胞脂肪瘤患者中的疗效.
- 评估afami- cel在该患者群体中的安全性.
主要方法:
- SPEARHEAD-1 是一个开放的,涉及23个地点的第二阶段试验.
- 在淋巴细胞减少后,52名曾经接受过重量治疗的患者接受了单剂量afami- cel.
- 主要终点是独立审查委员会评估的整体反应率.
主要成果:
- 总体应答率为37% (19/52),其中状肉瘤为39%,状圆细胞脂肪瘤为25%.
- 细胞因子释放综合征发生在71%的患者 (3级事件) 中.
- 3级或更严重的不良事件包括淋巴缺血 (96%),中性缺血 (85%) 和白血缺血 (81%). 没有发生与治疗相关的死亡.
结论:
- 在重度预先治疗的特定固体瘤患者中,阿法米细胞治疗带来了持久的反应.
- 这种T细胞受体治疗有效向固体瘤,支持其扩散到其他恶性瘤.
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