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CAR-T细胞疗法Idecabtagene Vicleucel治疗复发难治多发性骨髓瘤：已提交BLA

2020-07-30 Allan MedSci原创

多发性骨髓瘤Car-T细胞疗法idecabtagene vicleucel
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idecabtagene vicleucel（ide-cel，bb2121）是一款研究性靶向B细胞成熟抗原（BCMA）的嵌合抗原受体（CAR）T细胞免疫疗法，用于治疗复发难治性多发性骨髓瘤。

多发性骨髓瘤是一种浆细胞癌。尚不清楚多发性骨髓瘤的病因，目前尚无治愈方法。但是，有许多治疗方法可以用于治疗多发性骨髓瘤。曾暴露于三种主要药物（包括IMiD药物、PI和抗CD38抗体）的复发性和难治性多发性骨髓瘤患者的治疗选择较少且预后较差，包括较短的反应时间和较低的总生存期，因此亟需新的治疗手段。

百时美施贵宝（Bristol Myers Squibb）和Bluebird今日宣布，已向美国食品和药品监督管理局（FDA）提交其idecabtagene vicleucel（ide-cel，bb2121）的生物许可证申请（BLA）。idecabtagene vicleucel（ide-cel，bb2121）是一款研究性靶向B细胞成熟抗原（BCMA）的嵌合抗原受体（CAR）T细胞免疫疗法，用于治疗复发难治性多发性骨髓瘤。

关键性II期KarMMa研究评估了ide-cel治疗曾暴露于免疫调节剂（IMiD）、蛋白酶体抑制剂（PI）和抗CD38抗体的复发难治性多发性骨髓瘤患者的有效性和安全性。该研究的结果已在2020年美国临床肿瘤学会（ASCO20）虚拟会议上公布。

 

原始出处：

https://www.firstwordpharma.com/node/1744787?tsid=4

评论区 (10)
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    2021-03-20 lqvr

    #复发难治多发性骨髓瘤#

    0

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    2020-12-18 jml2009

    #多发性#

    0

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    2020-09-12 维他命

    #CEL#

    0

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topicName=Gene)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=63a4277, createdName=cy0324, createdTime=Mon Jul 05 12:30:54 CST 2021, time=2021-07-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1715511, encodeId=eef71e1551199, content=<a href='/topic/show?id=9c959406fa' target=_blank style='color:#2F92EE;'>#idecabtagene vicleucel#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9406, encryptionId=9c959406fa, topicName=idecabtagene vicleucel)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=753b31938391, createdName=12498ef1m41(暂无昵称), createdTime=Sat Sep 26 19:30:54 CST 2020, time=2020-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2046447, encodeId=e289204644e94, content=<a href='/topic/show?id=830c4258913' target=_blank style='color:#2F92EE;'>#复发难治#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42589, encryptionId=830c4258913, topicName=复发难治)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Wed Oct 28 10:30:54 CST 2020, time=2020-10-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=886019, encodeId=f2ad8860190e, content=👌, beContent=null, objectType=article, channel=null, level=null, likeNumber=138, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200918/133985b200ad44c386bfd27aa18100b5/cbb14ae7b1304dd59e34783b3c9b826d.jpg, createdBy=3dd05414640, createdName=ms4000000956890434, createdTime=Thu Sep 17 13:24:06 CST 2020, time=2020-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1781373, encodeId=09091e813736b, content=<a href='/topic/show?id=8ce8405907' target=_blank style='color:#2F92EE;'>#CAR-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, 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=Fri Mar 26 17:30:54 CST 2021, time=2021-03-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1291568, encodeId=c4dd129156899, content=<a href='/topic/show?id=2acd40e7ba' target=_blank style='color:#2F92EE;'>#Car-T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4077, encryptionId=2acd40e7ba, topicName=Car-T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=db7c233, createdName=changjitao2009, createdTime=Sat Aug 01 11:30:54 CST 2020, time=2020-08-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478045, encodeId=083214e80451a, content=<a href='/topic/show?id=bb6f18030a4' target=_blank style='color:#2F92EE;'>#T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18030, encryptionId=bb6f18030a4, topicName=T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bea7392214, createdName=124984edm24暂无昵称, createdTime=Sat Aug 01 11:30:54 CST 2020, time=2020-08-01, status=1, ipAttribution=)]
    2021-07-05 cy0324

    #Gene#

    0

  5. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478045, encodeId=083214e80451a, content=<a href='/topic/show?id=bb6f18030a4' target=_blank style='color:#2F92EE;'>#T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18030, encryptionId=bb6f18030a4, topicName=T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bea7392214, createdName=124984edm24暂无昵称, createdTime=Sat Aug 01 11:30:54 CST 2020, time=2020-08-01, status=1, ipAttribution=)]
    2020-09-26 12498ef1m41(暂无昵称)

    #idecabtagene vicleucel#

    0

  6. 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href='/topic/show?id=8ce8405907' target=_blank style='color:#2F92EE;'>#CAR-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, 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=Fri Mar 26 17:30:54 CST 2021, time=2021-03-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1291568, encodeId=c4dd129156899, content=<a href='/topic/show?id=2acd40e7ba' target=_blank style='color:#2F92EE;'>#Car-T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4077, encryptionId=2acd40e7ba, topicName=Car-T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=db7c233, createdName=changjitao2009, createdTime=Sat Aug 01 11:30:54 CST 2020, time=2020-08-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478045, encodeId=083214e80451a, content=<a href='/topic/show?id=bb6f18030a4' target=_blank style='color:#2F92EE;'>#T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18030, encryptionId=bb6f18030a4, topicName=T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bea7392214, createdName=124984edm24暂无昵称, createdTime=Sat Aug 01 11:30:54 CST 2020, time=2020-08-01, status=1, ipAttribution=)]
    2020-10-28 luoxiaog

    #复发难治#

    0

  7. 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href='/topic/show?id=8ce8405907' target=_blank style='color:#2F92EE;'>#CAR-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, 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=Fri Mar 26 17:30:54 CST 2021, time=2021-03-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1291568, encodeId=c4dd129156899, content=<a href='/topic/show?id=2acd40e7ba' target=_blank style='color:#2F92EE;'>#Car-T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4077, encryptionId=2acd40e7ba, topicName=Car-T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=db7c233, createdName=changjitao2009, createdTime=Sat Aug 01 11:30:54 CST 2020, time=2020-08-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478045, encodeId=083214e80451a, content=<a href='/topic/show?id=bb6f18030a4' target=_blank style='color:#2F92EE;'>#T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18030, encryptionId=bb6f18030a4, topicName=T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bea7392214, createdName=124984edm24暂无昵称, createdTime=Sat Aug 01 11:30:54 CST 2020, time=2020-08-01, status=1, ipAttribution=)]
    2020-09-17 ms4000000956890434

    👌

    0

  8. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478045, encodeId=083214e80451a, content=<a href='/topic/show?id=bb6f18030a4' target=_blank style='color:#2F92EE;'>#T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18030, encryptionId=bb6f18030a4, topicName=T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bea7392214, createdName=124984edm24暂无昵称, createdTime=Sat Aug 01 11:30:54 CST 2020, time=2020-08-01, status=1, ipAttribution=)]
    2021-03-26 仁者大医

    #CAR-#

    0

  9. 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objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42589, encryptionId=830c4258913, topicName=复发难治)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Wed Oct 28 10:30:54 CST 2020, time=2020-10-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=886019, encodeId=f2ad8860190e, content=👌, beContent=null, objectType=article, channel=null, level=null, likeNumber=138, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200918/133985b200ad44c386bfd27aa18100b5/cbb14ae7b1304dd59e34783b3c9b826d.jpg, createdBy=3dd05414640, createdName=ms4000000956890434, createdTime=Thu Sep 17 13:24:06 CST 2020, time=2020-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1781373, encodeId=09091e813736b, content=<a 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478045, encodeId=083214e80451a, content=<a href='/topic/show?id=bb6f18030a4' target=_blank style='color:#2F92EE;'>#T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18030, encryptionId=bb6f18030a4, topicName=T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bea7392214, createdName=124984edm24暂无昵称, createdTime=Sat Aug 01 11:30:54 CST 2020, time=2020-08-01, status=1, ipAttribution=)]
    2020-08-01 changjitao2009

    #Car-T细胞疗法#

    0

  10. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478045, encodeId=083214e80451a, content=<a href='/topic/show?id=bb6f18030a4' target=_blank style='color:#2F92EE;'>#T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18030, encryptionId=bb6f18030a4, topicName=T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bea7392214, createdName=124984edm24暂无昵称, createdTime=Sat Aug 01 11:30:54 CST 2020, time=2020-08-01, status=1, ipAttribution=)]
    2020-08-01 124984edm24暂无昵称

    #T细胞疗法#

    0

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卡非佐米、达雷木单抗联合地塞米松治疗可显著延长复发或难治性多发性骨髓瘤患者的无进展生存期

Blood：MIF是克服多发性骨髓瘤对蛋白酶体抑制剂耐药的生物标志物和靶点

MIF作为SOD1的伴侣，通过调节ROS诱导的线粒体功能障碍来介导MM细胞对PI的固有抗性；MIF和SOD1是预测MM患者对PI的反应的潜在生物标志物，也是克服MM PI耐药性的潜在靶点。

Brit J Heamatol：血清BDNF浓度预测多发性骨髓瘤患者的多发性神经病和总生存期

BDNF水平可能在预测MM患者CIPN中起预后作用，且是一个有用的生物标志物。

拓展阅读

【Cancer Letters】导致CAR-T细胞扩增和持续性缺陷的机制及应对策略

北京大学人民医院学者总结了CAR-T细胞在不同血液系统恶性肿瘤和实体肿瘤中的扩增和持续性特征，并分析了导致CAR-T细胞扩增和持续性缺陷的机制。

读书报告 | CAR-T 细胞治疗的长期并发症

本综述系统探讨了CAR-T治疗后非复发死亡率（NRM）的主要诱因——感染和继发性恶性肿瘤（如T细胞淋巴瘤）。

Med | CD19 CAR-T细胞疗法：为MDA5阳性皮肌炎伴间质性肺病患儿带来新希望

本研究首次报道了CD19 CAR-T细胞疗法在MDA5+DM-RPILD患儿中的应用。其在患儿中取得了显著的长期疗效，包括皮肤、运动和呼吸功能的改善，以及B细胞的重新生成。

【CBM】钱文斌/张会来教授等总结提高CAR-T淋巴瘤疗效的策略

本文综述了近年来为提高CAR-T细胞疗法在淋巴瘤治疗中的疗效所采取的多项策略，包括改进抗原识别、抑制免疫检查点信号、增强杀伤能力、提高安全性以及代谢和表观遗传调控等方面的创新方法。

综述：CAR-T的神经毒性

CAR-T 细胞疗法治疗癌症有疗效但伴神经毒性，综述探讨 ICANS、MNT、TIAN 三类神经毒性，分析其临床特征、机制、诊断等，强调多学科协作重要性。

首次报道！CART治疗DLBCL后五年持续存在CART细胞，成功自然怀孕并妊娠

近日报道了一例女性病例，该患者有弥漫性大 B 细胞淋巴瘤（DLBCL）病史，接受试验性 CAR-T 细胞治疗，5年后仍持续存在 CAR-T 细胞，随后妊娠并产下一名健康男孩。