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Precision生物获得FDA授权进行基因编辑的癌症免疫疗法的临床研究

2018-11-28 MedSci MedSci原创

PrecisionFDAPBCAR0191
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Precision生物科学和Servier近日宣布，美国食品和药物管理局（FDA）已接受PBCAR0191的研究性新药（IND）申请，PBCAR0191是一种用于B细胞急性淋巴细胞白血病（B-ALL）的同种异体抗CD19 CAR T疗法。

Precision生物科学和Servier近日宣布，美国食品和药物管理局（FDA）已接受PBCAR0191的研究性新药（IND）申请，PBCAR0191是一种用于B细胞急性淋巴细胞白血病（B-ALL）的同种异体抗CD19 CAR T疗法。

Precision公司首席执行官Matt Kane说：“我们的同种异体CAR T项目超出了所有人的预期，在三年内实现了从概念转向临床的跨越。我们认为这种治疗可能对患有NHL和B-ALL的患者具有变革性”。向IND提交的数据包括深度脱靶目标切割分析的结果和支持消除移植物抗体与宿主相互作用的证据。向FDA提供的制造数据则支持了T细胞基因组编辑生产过程的可扩展性和可重复性。作为抗击癌症的重大进展，CAR-T细胞疗法具有挽救许多对传统化疗和放射方案无反应的患者生命的潜力。目前市场上的自体CAR T疗法则依赖于源自患者的T细胞，其制备和生产耗时长、成本高。


原始出处：

http://www.firstwordpharma.com/node/1607411#axzz5Y7c6A8OV

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    2019-08-15 12498ebem19暂无昵称

    #CIS#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1993608, encodeId=c3371993608e9, content=<a href='/topic/show?id=17124e60f1' target=_blank style='color:#2F92EE;'>#CIS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4760, encryptionId=17124e60f1, topicName=CIS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3b172500206, createdName=12498ebem19暂无昵称, createdTime=Thu Aug 15 12:44:00 CST 2019, time=2019-08-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=353921, encodeId=36fe3539215b, content=学习了，希望可以早日攻克癌症, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c5051957123, createdName=L2X496, createdTime=Wed Nov 28 23:11:25 CST 2018, time=2018-11-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=353916, encodeId=3bcc35391664, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Wed Nov 28 22:42:17 CST 2018, time=2018-11-28, status=1, ipAttribution=)]
    2018-11-28 L2X496

    学习了，希望可以早日攻克癌症

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1993608, encodeId=c3371993608e9, content=<a href='/topic/show?id=17124e60f1' target=_blank style='color:#2F92EE;'>#CIS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4760, encryptionId=17124e60f1, topicName=CIS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3b172500206, createdName=12498ebem19暂无昵称, createdTime=Thu Aug 15 12:44:00 CST 2019, time=2019-08-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=353921, encodeId=36fe3539215b, content=学习了，希望可以早日攻克癌症, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c5051957123, createdName=L2X496, createdTime=Wed Nov 28 23:11:25 CST 2018, time=2018-11-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=353916, encodeId=3bcc35391664, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Wed Nov 28 22:42:17 CST 2018, time=2018-11-28, status=1, ipAttribution=)]
    2018-11-28 医者仁心5538

    学习了

    0