ASH 2020：亘喜生物BCMA/CD19双靶向CAR-T治疗复发或难治多发性骨髓瘤首次人体治疗数据惊艳

2020-12-07 医麦客医麦客

12月6日，致力于开发高效、经济的细胞疗法治疗癌症的全球临床阶段生物制药公司亘喜生物科技集团（Gracell Biotechnologies Inc.，简称“亘喜生物”）发布一

12月6日，致力于开发高效、经济的细胞疗法治疗癌症的全球临床阶段生物制药公司亘喜生物科技集团（Gracell Biotechnologies Inc.，简称“亘喜生物”）发布一项由研究者发起的一期临床试验结果，以评估其基于FasTCAR平台技术开发的首创 BCMA/CD19 双靶向CAR-T细胞疗法GC012F治疗复发或难治多发性骨髓瘤 (R/R MM) 患者的安全性和有效性。上海长征医院血液科主任傅卫军教授在2020年美国血液病学会 (ASH) 年会上以口头报告形式发表了此项数据。

GC012F是基于亘喜生物独有的可实现次日生产的FasTCAR平台技术开发的靶向BCMA/CD19双抗原的自体CAR-T细胞疗法。该候选产品已在一项由研究者发起的一期临床试验中进行了评估。截止到7月17日，该研究的三个剂量组共计入组16例患者，最高剂量水平为3×10^5细胞/千克。在接受标准淋巴清除方案三天后，患者接受了30分钟的GC012F单次输注。

早期总响应率(ORR)高达93.7%，所有响应均达到或超出VGPR，显示出快速、深入，且持久的响应特点。
接受最高剂量水平治疗的6例患者 (n=6) 均达到MRD阴性sCR，并且在数据截止时进行的六个月里程碑分析表明，其中4例患者（n=4）始终保持MRD阴性sCR状态。

该试验的中位随访时间为7.3个月（范围为 1-10 个月）。在16例接受治疗的患者中，有 93.7% 的患者根据mSMART 3.0指南被归为高危，19%是double hit R/R MM，31% 有髓外病变。患者的中位既往治疗线数为5，75%的患者对此前的治疗耐药，19%的患者为原发性耐药(primary refractory)。94% 的患者曾三重暴露于 (triple exposed) PI、IMiD和至少第三种治疗方式，包括抗CD38靶向治疗。63%的患者曾五重暴露于(penta-exposed) 至少五种不同的治疗方式，包括 PI、IMiD 和其他治疗方式。一例髓外病变患者在第 1 个月的首次骨髓评估中达到 MRD 阴性结果，但由于第 1 个月髓外病灶不断增大，他被判为无响应患者。

GC012F的安全性可控，细胞因子释放综合征 (CRS)总体等级较低（87.5%的患者为1/2级，2例患者达到3 级，没有出现4 级或5级事件），中位持续时间为 4 天（范围为 1-8 天）。对 CRS 采用标准护理治疗，包括托希利珠单抗和类固醇，所有病例均得到缓解。16 例患者中均未观察到 ICANS（免疫效应细胞相关的神经毒性事件）。治疗期间发生的不良事件 (TEAEs) 主要表现为血细胞减少和AST增加。三例患者出现下呼吸道感染。所有TEAEs 经标准治疗后均得到缓解。

“这16例患者绝大多数具有高危特征，而这些早期临床发现让我们备受鼓舞，”亘喜生物首席医学官Martina Sersch 博士（MD，PhD）表示，“高危患者很难治疗成功，也很难达到长期缓解。接受最高剂量水平GC012F治疗的患者，100%在输注后的六个月均达到MRD阴性sCR，这表明对于既往接受过大量、多种治疗，但未能成功响应或对标准治疗不再响应的患者，有望从该产品中获益。亘喜正在推进该项目的全球开发，同时期待在不久的将来分享该项目最新的动态。”

关于亘喜生物

亘喜生物科技集团（Gracell Biotechnologies Inc.，简称“亘喜生物”）是一家致力于发现和开发突破性细胞疗法的全球临床阶段生物制药公司。利用其突破性的 FasTCAR 和 TruUCAR 技术平台，亘喜生物正在开发包含多种自体和同种异体细胞的候选产品，这些产品可能克服传统 CAR-T 疗法的行业挑战，包括制造时间长、生产质量欠佳、治疗成本高，和对实体瘤疗效有限等。

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#插入话题

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2021-01-17 仁者大医

#CAR-#

35 0
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2021-11-12 jml2009

#多发性#

28 0
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2021-01-17 jiafeimao123

免疫治疗热点

51 0
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2020-12-12 ms4000001626131795

#学习#这个很不错

77 0
[GetPortalCommentsPageByObjectIdResponse(id=1781394, encodeId=29391e813943f, content=<a href='/topic/show?id=8ce8405907' target=_blank style='color:#2F92EE;'>#CAR-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, 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=Sun Jan 17 05:25:26 CST 2021, time=2021-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890194, encodeId=184d1890194de, 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=28, 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=Fri Nov 12 12:25:26 CST 2021, time=2021-11-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=917486, encodeId=4f8891e486e3, content=免疫治疗热点, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220704/3e89e688a15b4b399673908d8617a0ae/ab0a0bdeba5e4dcdb873d9a9867e5714.jpg, createdBy=98a31643603, createdName=jiafeimao123, createdTime=Sun Jan 17 15:34:50 CST 2021, time=2021-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=907350, encodeId=8e2f90e35027, content=<a href='/topic/show?id=23e3454e353' target=_blank style='color:#2F92EE;'>#学习#</a>这个很不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45473, encryptionId=23e3454e353, topicName=学习)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36115442044, createdName=ms4000001626131795, createdTime=Sat Dec 12 18:29:25 CST 2020, time=2020-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301319, encodeId=223d1301319a2, content=<a href='/topic/show?id=38e32852fe' target=_blank style='color:#2F92EE;'>#ASH#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2852, encryptionId=38e32852fe, topicName=ASH)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=39a0295, createdName=kksonne, createdTime=Wed Dec 09 03:25:26 CST 2020, time=2020-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416464, encodeId=435914164642a, content=<a href='/topic/show?id=924442e98f' target=_blank style='color:#2F92EE;'>#CD19#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4279, encryptionId=924442e98f, topicName=CD19)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f1583186918, createdName=dingxiaobo, createdTime=Wed Dec 09 03:25:26 CST 2020, time=2020-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1460230, encodeId=8a8a14602304d, content=<a href='/topic/show?id=833732e80d' target=_blank style='color:#2F92EE;'>#BCMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3278, encryptionId=833732e80d, topicName=BCMA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=85f46265562, createdName=yykkxiaodou, createdTime=Wed Dec 09 03:25:26 CST 2020, time=2020-12-09, status=1, ipAttribution=)]
2020-12-09 kksonne

#ASH#

41 0
[GetPortalCommentsPageByObjectIdResponse(id=1781394, encodeId=29391e813943f, content=<a href='/topic/show?id=8ce8405907' target=_blank style='color:#2F92EE;'>#CAR-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, 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=Sun Jan 17 05:25:26 CST 2021, time=2021-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890194, encodeId=184d1890194de, 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=28, 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=Fri Nov 12 12:25:26 CST 2021, time=2021-11-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=917486, encodeId=4f8891e486e3, content=免疫治疗热点, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220704/3e89e688a15b4b399673908d8617a0ae/ab0a0bdeba5e4dcdb873d9a9867e5714.jpg, createdBy=98a31643603, createdName=jiafeimao123, createdTime=Sun Jan 17 15:34:50 CST 2021, time=2021-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=907350, encodeId=8e2f90e35027, content=<a href='/topic/show?id=23e3454e353' target=_blank style='color:#2F92EE;'>#学习#</a>这个很不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45473, encryptionId=23e3454e353, topicName=学习)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36115442044, createdName=ms4000001626131795, createdTime=Sat Dec 12 18:29:25 CST 2020, time=2020-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301319, encodeId=223d1301319a2, content=<a href='/topic/show?id=38e32852fe' target=_blank style='color:#2F92EE;'>#ASH#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2852, encryptionId=38e32852fe, topicName=ASH)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=39a0295, createdName=kksonne, createdTime=Wed Dec 09 03:25:26 CST 2020, time=2020-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416464, encodeId=435914164642a, content=<a href='/topic/show?id=924442e98f' target=_blank style='color:#2F92EE;'>#CD19#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4279, encryptionId=924442e98f, topicName=CD19)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f1583186918, createdName=dingxiaobo, createdTime=Wed Dec 09 03:25:26 CST 2020, time=2020-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1460230, encodeId=8a8a14602304d, content=<a href='/topic/show?id=833732e80d' target=_blank style='color:#2F92EE;'>#BCMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3278, encryptionId=833732e80d, topicName=BCMA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=85f46265562, createdName=yykkxiaodou, createdTime=Wed Dec 09 03:25:26 CST 2020, time=2020-12-09, status=1, ipAttribution=)]
2020-12-09 dingxiaobo

#CD19#

30 0
[GetPortalCommentsPageByObjectIdResponse(id=1781394, encodeId=29391e813943f, content=<a href='/topic/show?id=8ce8405907' target=_blank style='color:#2F92EE;'>#CAR-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, 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=Sun Jan 17 05:25:26 CST 2021, time=2021-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890194, encodeId=184d1890194de, 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=28, 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=Fri Nov 12 12:25:26 CST 2021, time=2021-11-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=917486, encodeId=4f8891e486e3, content=免疫治疗热点, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220704/3e89e688a15b4b399673908d8617a0ae/ab0a0bdeba5e4dcdb873d9a9867e5714.jpg, createdBy=98a31643603, createdName=jiafeimao123, createdTime=Sun Jan 17 15:34:50 CST 2021, time=2021-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=907350, encodeId=8e2f90e35027, content=<a href='/topic/show?id=23e3454e353' target=_blank style='color:#2F92EE;'>#学习#</a>这个很不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45473, encryptionId=23e3454e353, topicName=学习)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36115442044, createdName=ms4000001626131795, createdTime=Sat Dec 12 18:29:25 CST 2020, time=2020-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301319, encodeId=223d1301319a2, content=<a href='/topic/show?id=38e32852fe' target=_blank style='color:#2F92EE;'>#ASH#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2852, encryptionId=38e32852fe, topicName=ASH)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=39a0295, createdName=kksonne, createdTime=Wed Dec 09 03:25:26 CST 2020, time=2020-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416464, encodeId=435914164642a, content=<a href='/topic/show?id=924442e98f' target=_blank style='color:#2F92EE;'>#CD19#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4279, encryptionId=924442e98f, topicName=CD19)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f1583186918, createdName=dingxiaobo, createdTime=Wed Dec 09 03:25:26 CST 2020, time=2020-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1460230, encodeId=8a8a14602304d, content=<a href='/topic/show?id=833732e80d' target=_blank style='color:#2F92EE;'>#BCMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3278, encryptionId=833732e80d, topicName=BCMA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=85f46265562, createdName=yykkxiaodou, createdTime=Wed Dec 09 03:25:26 CST 2020, time=2020-12-09, status=1, ipAttribution=)]
2020-12-09 yykkxiaodou

#BCMA#

38 0

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