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**iPSC衍生的CAR-T细胞疗法：IND已获FDA批准

2020-07-11 Allan MedSci原创

iPSCs慢性淋巴细胞性白血病Car-T细胞疗法
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Fate Therapeutics是一家临床阶段的生物制药公司，致力于开发抗癌症和免疫疾病的细胞免疫疗法，今日宣布，美国FDA已批准FT819的研究性新药申请（IND）。

Fate Therapeutics是一家临床阶段的生物制药公司，致力于开发抗癌症和免疫疾病的细胞免疫疗法，今日宣布，美国FDA已批准FT819的研究性新药申请（IND）。FT819是一种针对CD19+恶性肿瘤的源自诱导多能干细胞（iPSC）的CAR-T细胞疗法，旨在提高CAR-T细胞疗法的安全性和有效性。Fate Therapeutics计划启动FT819的I期临床试验，以治疗复发难治B细胞恶性肿瘤，包括慢性淋巴细胞性白血病（CLL）、急性淋巴细胞性白血病（ALL）和非霍奇金淋巴瘤（NHL）。多中心I期临床试验旨在确定FT819的最大耐受剂量，并评估FT819治疗三种B细胞恶性肿瘤（CLL、ALL和NHL）的安全性和临床活性。每个适应症将独立注册并评估三种剂量递增方案。

FT819旨在解决当前CAR-T细胞疗法的若干限制。使用iPSC细胞系作为起始细胞来源，这使CAR-T细胞能够大量生产并可交付给患者使用。

 

原始出处：

https://www.firstwordpharma.com/node/1739480

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    2021-05-09 bugit

    #FDA批准#

    0

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    2020-11-20 仁者大医

    #CAR-#

    0

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    2020-07-13 changjitao2009

    #Car-T细胞疗法#

    0

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    2020-07-13 chengjn

    #iPS#

    0

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    2020-07-13 gjsgj

    #PSC#

    0

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    2020-07-13 xiaogang319

    #IND#

    0

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    2020-07-13 124984edm24暂无昵称

    #T细胞疗法#

    0

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    2020-07-13 neurosurgeon

    #iPSC#

    0

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Sci Transl Med：iPSC分化的神经祖细胞在小型猪模型中的脊髓移植获得成功

使用从诱导多能干细胞(induced pluripotent stem cells， iPSCs)分化生成的同源(syngeneic)或同种异体(allogeneic)细胞来治疗疾病和损伤具备良好的临床应用前景。