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FDA授予CAR-T癌症疗法CLBR001 + SWI019“快速通道称号”

2020-10-02 Allan MedSci原创

CAR-T疗法CAR-T细胞CLBR001 + SWI019快速通道称号Calibr
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美国FDA已授予Calibr研发的新型“可切换”CAR-T细胞疗法CLBR001 + SWI019“快速通道称号”，以加快药物开发和审查。

美国FDA已授予Calibr研发的新型“可切换”CAR-T细胞疗法CLBR001 + SWI019“快速通道称号”，以加快药物开发和审查。目前，该疗法正在评估作为B细胞恶性肿瘤的治疗方法，B细胞恶性肿瘤包括非霍奇金淋巴瘤和慢性淋巴细胞性白血病。

CAR-T细胞疗法CLBR001 + SWI019已开始招募受试者参加I期临床试验，旨在评估该细胞疗法的安全性和耐受性，这项研究正在美国的多个地点进行。

Calibr首席医学官Pamela Garzone博士说：“快速通道称号将使Calibr能够在相关研究上与FDA进行互动，例如适当的数据收集和研究设计，以支持该创新疗法的获批”。

Calibr研究性的CAR-T细胞疗法利用患者自身的免疫细胞来治疗癌症，使这些细胞处于新型分子“开关”的控制之下，该“开关”试图减轻迄今为止可能威胁生命的副作用，这些副作用已阻碍了细胞疗法的使用。

Calibr的“可切换”CAR-T细胞疗法结合了一种称为“SWI019”的抗体，该抗体可作为“开关”，激活工程细胞（CLBR001），并指导它们与癌症靶标结合。这可以使医生对治疗有更多的控制，从而可以提供明显的安全优势。在临床前研究中，该方法被证明在消除肿瘤，同时控制因治疗而产生的细胞因子方面非常有效。

 

原始出处：

https://www.firstwordpharma.com/node/1762161?tsid=4

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    2021-04-22 mnda

    #癌症疗法#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1752917, encodeId=732b1e529171d, content=<a href='/topic/show?id=b103e1424b2' target=_blank style='color:#2F92EE;'>#癌症疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71424, encryptionId=b103e1424b2, topicName=癌症疗法)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c1e236589107, createdName=mnda, createdTime=Thu Apr 22 06:26:52 CST 2021, time=2021-04-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1781387, encodeId=de8f1e813874c, content=<a href='/topic/show?id=8ce8405907' target=_blank style='color:#2F92EE;'>#CAR-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4059, encryptionId=8ce8405907, topicName=CAR-)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Wed Jan 20 23:26:52 CST 2021, time=2021-01-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=889676, encodeId=90c88896e650, content=学习了，科技进步, beContent=null, objectType=article, channel=null, level=null, likeNumber=98, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=97be5414604, createdName=ms6000001136183965, createdTime=Fri Oct 02 11:22:57 CST 2020, time=2020-10-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=889673, encodeId=41838896e326, content=😀, beContent=null, objectType=article, channel=null, level=null, likeNumber=104, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201002/f797ef27f8404cbea57c37763481fad6/83ee564fee114b5b8ae649eabb7c7f4b.jpg, createdBy=37495423143, createdName=ms5000000202291935, createdTime=Fri Oct 02 11:08:43 CST 2020, time=2020-10-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=889672, encodeId=9b7e8896e252, content=科技进步, beContent=null, objectType=article, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201002/f797ef27f8404cbea57c37763481fad6/83ee564fee114b5b8ae649eabb7c7f4b.jpg, createdBy=37495423143, createdName=ms5000000202291935, createdTime=Fri Oct 02 11:08:20 CST 2020, time=2020-10-02, status=1, ipAttribution=)]
    2021-01-20 仁者大医

    #CAR-#

    0

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    2020-10-02 ms6000001136183965

    学习了，科技进步

    0

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    2020-10-02 ms5000000202291935

    😀

    0

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    2020-10-02 ms5000000202291935

    科技进步

    0

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