FDA暂停CAR-T疗法UCARTCS1治疗多发性骨髓瘤的临床试验

2020-11-19 Allan MedSci原创

制药公司Cellectis今日宣布,FDA已经暂停了MELANI-01 I期临床试验,该试验旨在评估CAR-T疗法UCARTCS1治疗复发难治多发性骨髓瘤(MM)的有效性和安全性。

制药公司Cellectis今日宣布,FDA已经暂停了MELANI-01 I期临床试验,该试验旨在评估CAR-T疗法UCARTCS1治疗复发难治多发性骨髓瘤(MM)的有效性和安全性。在该研究中,一名患者经历了致命性紧急心脏骤停事件后,FDA于7月下令暂停治疗。

当时,该公司指出,接受UCARTCS1第二剂量治疗的患者在入组前未接受包括自体CAR-T细胞在内的多种治疗方法的治疗。Cellectis还表示,在FDA宣布临床保留之前,该公司已经决定扩大第一个剂量水平的注册人数,并建议根据初步临床数据确定II期临床的推荐剂量。

Cellectis首席医学官Carrie Brownstein说:“过去几个月来,Cellectis一直在与FDA合作,以解决该机构的要求,其中包括对MELANI-01研究方案进行了调整,以提高安全性。我们对UCARTCS1的潜在临床益处仍然充满信心”。

UCARTCS1设计用于治疗表达CS1 / SLAMF7的血液系统恶性肿瘤。同时,该公司表示,正在进行其他两项CAR-T疗法的临床试验,其中包括UCART123治疗复发难治急性髓细胞性白血病、UCART22治疗复发难治B细胞急性淋巴细胞白血病。

 

原始出处:

https://www.firstwordpharma.com/node/1775450?tsid=4

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    2021-10-23 marongnuan
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    2021-02-27 jml2009
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    2021-05-17 仁者大医
  4. [GetPortalCommentsPageByObjectIdResponse(id=2016561, encodeId=648120165616d, content=<a href='/topic/show?id=04cb1e21583' target=_blank style='color:#2F92EE;'>#TCS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17215, encryptionId=04cb1e21583, topicName=TCS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b191324, createdName=marongnuan, createdTime=Sat Oct 23 23:28:27 CST 2021, time=2021-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890186, encodeId=8418189018679, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Sat Feb 27 22:28:27 CST 2021, time=2021-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1781392, encodeId=db411e8139298, content=<a href='/topic/show?id=8ce8405907' target=_blank style='color:#2F92EE;'>#CAR-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, 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=Mon May 17 15:28:27 CST 2021, time=2021-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=900546, encodeId=4f319005460a, content=制药公司Cellectis今日宣布,FDA已经暂停了MELANI-01 I期临床试验,该试验旨在评估CAR-T疗法UCARTCS1治疗复发难治多发性骨髓瘤(MM)的有效性和安全性。, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e4265295917, createdName=zhanyuting, createdTime=Thu Nov 19 17:25:20 CST 2020, time=2020-11-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=901472, encodeId=b84f9014e2e9, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0c3f2479712, createdName=12455fddm60暂无昵称, createdTime=Mon Nov 23 15:39:52 CST 2020, time=2020-11-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=900961, encodeId=6fc590096170, content=治疗的希望又少了一个, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200914/f1df8506d5cb4909bac2efc340b6c1fe/dcc6dd2dbec44613838b555fbe723804.jpg, createdBy=686b1371609, createdName=liyu7822, createdTime=Sat Nov 21 10:05:13 CST 2020, time=2020-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1357614, encodeId=f16b135e614fc, content=<a href='/topic/show?id=b0702e84b9' target=_blank style='color:#2F92EE;'>#ART#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2784, encryptionId=b0702e84b9, topicName=ART)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sat Nov 21 06:28:27 CST 2020, time=2020-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1477269, encodeId=b97714e7269b2, content=<a href='/topic/show?id=429a41149d' target=_blank style='color:#2F92EE;'>#cART#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4114, encryptionId=429a41149d, topicName=cART)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=46987366013, createdName=ms2999106592497887, createdTime=Sat Nov 21 06:28:27 CST 2020, time=2020-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=900516, encodeId=96229005162e, content=一个新药出局了, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200914/f1df8506d5cb4909bac2efc340b6c1fe/dcc6dd2dbec44613838b555fbe723804.jpg, createdBy=686b1371609, createdName=liyu7822, createdTime=Thu Nov 19 16:00:20 CST 2020, time=2020-11-19, status=1, ipAttribution=)]
    2020-11-19 zhanyuting

    制药公司Cellectis今日宣布,FDA已经暂停了MELANI-01 I期临床试验,该试验旨在评估CAR-T疗法UCARTCS1治疗复发难治多发性骨髓瘤(MM)的有效性和安全性。

    0

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    2020-11-23 12455fddm60暂无昵称

    学习

    0

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    2020-11-21 liyu7822

    治疗的希望又少了一个

    0

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    2020-11-21 zhaojie88
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    2020-11-19 liyu7822

    一个新药出局了

    0

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