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NEJM:Ide-cel治疗复发性多发性骨髓瘤患者II期临床获得成功

2021-03-01 MedSci原创 MedSci原创

超过7成的难治性和复发性骨髓瘤患者在接受ide-cel治疗后有应答,其中近3成患者实现微小残留疾病阴性,几乎所有患者出现3级或4级不良事件,最常见的是血液学毒性和细胞因子释放综合征

对于复发性多发性骨髓瘤患者,目前的治疗手段主要包括免疫调节药物、蛋白酶体抑制剂和CD38抗体,但患者治疗后效果较差,中位无进展生存期仅3到4个月,总生存期约8到9个月。嵌合抗原受体(CAR)修饰的T细胞是新近研发的治疗手段,其中CD19导向的CART细胞已被批准用于B细胞癌。
Idecabtagene vicleucl(ide-cel,又称bb2121)是靶向BCMA的CAR-T细胞免疫疗法,近日研究人员考察了ide-cel对复发和难治性多发性骨髓瘤患者的疗效和安全性。
 
本次研究为II期临床研究,患者先前至少接受三个治疗方案,包括蛋白酶体抑制剂,免疫调节剂和抗CD38抗体,患者接受150×106至450×106CAR阳性(CAR+)T细胞。研究的主要终点是总体反应(部分治疗应答或更好),关键次要终点是完全治疗应答或更好(包括完全和严格的完全治疗应答)。
 
128例接受ide-cel治疗,在平均13.3个月的随访中,128名患者中有94名(73%)对治疗有应答,其中42名(33%)患者有完全治疗应答或更好。33例患者实现了微小残留疾病(MRD)-阴性,占所有128例接受治疗患者的26% ,在42例完全缓解或更好的患者中占79%。中位无进展生存期为8.8个月。在128例接受治疗的患者中,常见的毒性反应包括中性粒细胞减少(117例,91%),贫血(89例,70%),血小板减少症 (81例,63%)。107名患者(84%)报告了细胞因子释放综合征,其中7名(5%)为等级3级或更高。23名患者出现神经毒性反应(18%),其中3级4例(3%),未出现3级以上神经毒性反应发生。细胞动力学分析证实49例患者中有29例(59%)在输注后6个月出现CAR+T细胞,11例患者中有4例(36%)在输注后12个月出现CAR+T细胞。
 
研究发现,超过7成的难治性和复发性骨髓瘤患者在接受ide-cel治疗后有应答,其中近3成患者实现微小残留疾病阴性,几乎所有患者出现3级或4级不良事件,最常见的是血液学毒性和细胞因子释放综合征。
 
原始出处:
 
Nikhil C. Munshi et al. Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. N Engl J Med, February 25 2021.

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    2021-09-04 jml2009
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    2022-01-19 维他命
  6. [GetPortalCommentsPageByObjectIdResponse(id=1890226, encodeId=298f18902262b, 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=36, 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 Sep 04 16:06:37 CST 2021, time=2021-09-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1909881, encodeId=70471909881f3, content=<a href='/topic/show?id=8f1f42518d8' target=_blank style='color:#2F92EE;'>#复发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42518, encryptionId=8f1f42518d8, topicName=复发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Thu Dec 30 23:06:37 CST 2021, time=2021-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1653164, encodeId=0774165316416, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Sun Dec 12 01:06:37 CST 2021, time=2021-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1718340, encodeId=71141e183403b, content=<a href='/topic/show?id=5a014253400' target=_blank style='color:#2F92EE;'>#复发性多发性骨髓瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42534, encryptionId=5a014253400, topicName=复发性多发性骨髓瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ab3732554119, createdName=meichuangyi, createdTime=Thu Jul 15 18:06:37 CST 2021, time=2021-07-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1962467, encodeId=78f8196246e6b, content=<a href='/topic/show?id=dbe6445416' target=_blank style='color:#2F92EE;'>#CEL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4454, encryptionId=dbe6445416, topicName=CEL)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ff68, createdName=维他命, createdTime=Wed Jan 19 10:06:37 CST 2022, time=2022-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524929, encodeId=554a1524929c5, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Wed Mar 03 10:06:37 CST 2021, time=2021-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035591, encodeId=93b4103559165, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Mon Mar 01 22:06:37 CST 2021, time=2021-03-01, status=1, ipAttribution=)]
  7. [GetPortalCommentsPageByObjectIdResponse(id=1890226, encodeId=298f18902262b, 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=36, 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 Sep 04 16:06:37 CST 2021, time=2021-09-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1909881, encodeId=70471909881f3, content=<a href='/topic/show?id=8f1f42518d8' target=_blank style='color:#2F92EE;'>#复发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42518, encryptionId=8f1f42518d8, topicName=复发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Thu Dec 30 23:06:37 CST 2021, time=2021-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1653164, encodeId=0774165316416, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Sun Dec 12 01:06:37 CST 2021, time=2021-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1718340, encodeId=71141e183403b, content=<a href='/topic/show?id=5a014253400' target=_blank style='color:#2F92EE;'>#复发性多发性骨髓瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42534, encryptionId=5a014253400, topicName=复发性多发性骨髓瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ab3732554119, createdName=meichuangyi, createdTime=Thu Jul 15 18:06:37 CST 2021, time=2021-07-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1962467, encodeId=78f8196246e6b, content=<a href='/topic/show?id=dbe6445416' target=_blank style='color:#2F92EE;'>#CEL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4454, encryptionId=dbe6445416, topicName=CEL)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ff68, createdName=维他命, createdTime=Wed Jan 19 10:06:37 CST 2022, time=2022-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524929, encodeId=554a1524929c5, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Wed Mar 03 10:06:37 CST 2021, time=2021-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035591, encodeId=93b4103559165, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Mon Mar 01 22:06:37 CST 2021, time=2021-03-01, status=1, ipAttribution=)]
    2021-03-01 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

    0

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