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Allogene与Servier宣布FDA批准ALLO-501的IND

2019-01-29 MedSci MedSci原创

AllogeneALLO-501同种异体CAR-TCD19
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Allogene是一家临床阶段生物技术公司，与其开发合作伙伴Servier（一家独立的国际制药公司）合作，率先开发了一种抗CD19的同种异体CAR-T（ALLO-501）癌症治疗药物，Allogene与Servier近日宣布美国食品和药品监督管理局（FDA）已批准ALLO-501的研究性新药申请（IND）用于治疗复发/难治性非霍奇金淋巴瘤（NHL）患者。

Allogene是一家临床阶段生物技术公司，与其开发合作伙伴Servier（一家独立的国际制药公司）合作，率先开发了一种抗CD19的同种异体CAR-T（ALLO-501）癌症治疗药物，Allogene与Servier近日宣布美国食品和药品监督管理局（FDA）已批准ALLO-501的研究性新药申请（IND）用于治疗复发/难治性非霍奇金淋巴瘤（NHL）患者。

该研究的第I阶段部分（ALPHA I期试验）旨在评估复发/难治性弥漫性大B细胞淋巴瘤（DLBCL）或滤泡性淋巴瘤（FL）最常见NHL亚型对ALLO-501剂量水平升高的安全性和耐受性。ALLO-501将在使用氟达拉滨/环磷酰胺（Flu / Cy）和ALLO-647（Allogene的专有抗CD52单克隆抗体）进行淋巴细胞清除后进行。ALPHA I期试验将治疗多达24名患者，并将于2019年上半年开始实施。

Allogene总裁，首席执行官兼联合创始人David Chang博士说：“很高兴FDA批准我们的IND来加速ALLO-501计划，这将是肿瘤治疗的又一个里程碑”。 


原始出处：

http://www.firstwordpharma.com/node/1621402#axzz5dxBELT9v

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    2019-11-01 cy0324

    #Gene#

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    2019-03-14 makuansheng

    #Servier#

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    2019-09-14 智者为医08

    #FDA批准#

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    2019-01-31 膀胱癌

    #ALL#

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    2019-01-31 xiaogang319

    #IND#

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