AACR 2020：CAR-T治疗复发性或难治性(R/R)急性T淋巴细胞白血病试验初步结果公布

2020-04-29 亘喜生物亘喜生物

急性T淋巴细胞白血病(T-ALL)是一种侵袭性极强的急性T细胞恶性肿瘤，伴有骨髓和髓外组织的浸润。数据统计，2015 年全球共有约87.6万人患有ALL，有 11 万人因其死亡，其中儿童和成人T-AL

急性T淋巴细胞白血病(T-ALL)是一种侵袭性极强的急性T细胞恶性肿瘤，伴有骨髓和髓外组织的浸润。数据统计，2015 年全球共有约87.6万人患有ALL，有 11 万人因其死亡，其中儿童和成人T-ALL患者约占 ALL总数的15%-20%。40%-50%的患者预计会在一线治疗后2年内复发，而其它可选择的治疗十分有限。复发性或难治性T-ALL的现有治疗效果仍不理想，治疗手段极为有限。大多数T-ALL患者在多种药物联合化疗后的两年内出现复发。

临床开发阶段免疫细胞与基因治疗企业亘喜生物集团（Gracell Biotechnologies) 公布了其在研的通用型TruUCAR™ GC027治疗复发性或难治性(R/R)急性T淋巴细胞白血病(T-ALL)的临床试验结果，在美国时间28日在AACR上公布。

此次AACR年会上，亘喜生物报告其通用型TruUCAR™ GC027产品的一项1期临床试验数据。该首次人体（first-in-human）试验旨在验证其治疗复发或难治(R/R)急性T淋巴细胞白血病(T-ALL)的可行性。报告题目为：Safety and efficacy clinical study of TruUCART™ GC027: the first-in-human, universal CAR-T therapy for relapsed/refractory T-cell acute lymphoblastic leukemia

GC027是以TruUCAR™技术为基础的产品，来源于无需HLA匹配的健康供者细胞，经过体外基因修饰表达嵌合抗原受体(CAR)，同时增强了细胞的性能，从而可特异高效地消除T肿瘤靶细胞。TruUCAR TM技术无需通过联合抗CD52药物来抑制肿瘤细胞，诱导患者体内产生长期免疫抑制来促使即用型CAR-T细胞在体内扩增和杀伤肿瘤细胞。GC027经过特有的CRISPR基因编辑策略的改造，可以达到避免移植物抗宿主病(GvHD)、减轻患者免疫系统引起的排斥反应、并在体内有效扩增，达到清除肿瘤靶细胞的目的。

该临床试验是由研究者发起 (IIT) 的首次人体试验，旨在评估通用型TruUCAR™ GC027治疗R/R T-ALL患者的安全性和有效性。截止到今年二月，该试验共入组5名R/R T-ALL受试者，受试者曾接受的既往治疗中位数为5次（范围为1-9 次）。基线的骨髓肿瘤负荷为38.2%（范围为4%-80.2%）。所有患者均接受了单次TruUCAR™ GC027的输注，输注计量为高中低三组计量组中的一种：0.6*10⁷ 细胞/kg体重、1.0*10⁷ 细胞/kg体重，或1.5*10⁷ 细胞/kg体重。值得注意的是，5名受试者均未进行人类白细胞组织相容性抗原（HLA）配型，输注后均未接受造血干细胞移植（HSCT）。

通过28天随访，对5名受试者进行了评估，5名(100%)受试者获得完全缓解，其中包括血细胞数量完全或未完全恢复(CR/CRi)；4名(80%)受试者获得最小残留疾病阴性的完全缓解(MRD-CR)。

所有5名受试者均能够耐受TruUCAR™ GC027单次输注，试验中未观察到神经毒性事件或急性移植物抗宿主病(aGvHD)发生，同时观察到所有5名受试者均出现不同程度的细胞因子释放综合征(CRS)，均在可控范围内。

亘喜生物集团首席医学官Martina Sersch博士说道，“我们很高兴地报告首批5名受试者接受TruUCAR™ GC027的治疗，他们的疾病得到了有效的控制，初步试验结果令人振奋。另外，TruUCAR™的平台技术通过GC027候选产品得到了进一步验证，我们将继续推进该技术平台在其他未被满足领域的应用。”

关于TruUCAR™

TruUCAR™是亘喜生物独有的专利平台技术，对T细胞上选定的基因进行编辑，在不使用免疫抑制药物的情况下降低移植物抗宿主病(GvHD)和免疫排斥的风险。TruUCAR™技术使得同种异体CAR-T细胞可在HLA不匹配的患者（受者）体内增殖并持续存在，同时控制GvHD的风险。TruUCAR™产品的目标病人，包括但不限于那些已接受自体CAR-T治疗但无法获益，或因感染原因导致无法提供合规的细胞，或自体CAR-T细胞生产失败的患者；更重要的是，TruUCAR™产品即用型的属性，使得患者能够得到及时救治；其低廉的制造成本使得重复给药的方案成为可能。除了T-ALL抗原以外，该平台技术还可用于其它血液肿瘤的靶点。

关于GC027

GC027使用了亘喜独有的TruUCAR™专利技术，利用无需进行HLA匹配的健康供者T细胞，是一种在研的即用型CAR-T细胞疗法，能够靶向CD7抗原表达的肿瘤细胞，用于治疗T细胞恶性肿瘤。

关于亘喜生物集团

亘喜生物集团是一家临床开发阶段的生物制药公司，致力于开发可靠实惠的癌症细胞基因疗法。亘喜生物致力于 CAR-T 的攻坚克难，如生产成本高、生产过程冗长、缺乏即用型的产品，以及对实体肿瘤无效等问题。在其世界级科学家团队的带领下，亘喜生物正在开发 FasTCAR™、TruUCAR™即用型CAR-T产品）、Dual CAR 和 Enhanced CAR-T 细胞疗法，用于治疗白血病、淋巴瘤、骨髓瘤和实体瘤等疾病。

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2021-03-19 shanyongle

#结果公布#

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2020-11-11 仁者大医

#CAR-#

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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1552018, encodeId=7fb0155201812, content=<a href='/topic/show?id=169c166430' target=_blank style='color:#2F92EE;'>#AACR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1664, encryptionId=169c166430, topicName=AACR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6b2714248200, createdName=Luyuxie_14, createdTime=Fri May 01 03:33:08 CST 2020, time=2020-05-01, status=1, ipAttribution=)]
2021-01-19 sunyl07

#淋巴细胞白血病#

59 0
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href='/topic/show?id=e7c018e7af' target=_blank style='color:#2F92EE;'>#ACR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1877, encryptionId=e7c018e7af, topicName=ACR)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=19792261142, createdName=10518094zz, createdTime=Fri May 01 03:33:08 CST 2020, time=2020-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1528657, encodeId=2472152865efb, content=<a href='/topic/show?id=74b798601a1' target=_blank style='color:#2F92EE;'>#难治性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98601, encryptionId=74b798601a1, topicName=难治性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a1ef11916292, createdName=freve, createdTime=Fri May 01 03:33:08 CST 2020, time=2020-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1552018, encodeId=7fb0155201812, content=<a href='/topic/show?id=169c166430' target=_blank style='color:#2F92EE;'>#AACR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1664, encryptionId=169c166430, topicName=AACR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6b2714248200, createdName=Luyuxie_14, createdTime=Fri May 01 03:33:08 CST 2020, time=2020-05-01, status=1, ipAttribution=)]
2020-08-06 zhaojie88

#AACR 2020#

63 0
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href='/topic/show?id=e7c018e7af' target=_blank style='color:#2F92EE;'>#ACR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1877, encryptionId=e7c018e7af, topicName=ACR)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=19792261142, createdName=10518094zz, createdTime=Fri May 01 03:33:08 CST 2020, time=2020-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1528657, encodeId=2472152865efb, content=<a href='/topic/show?id=74b798601a1' target=_blank style='color:#2F92EE;'>#难治性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98601, encryptionId=74b798601a1, topicName=难治性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a1ef11916292, createdName=freve, createdTime=Fri May 01 03:33:08 CST 2020, time=2020-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1552018, encodeId=7fb0155201812, content=<a href='/topic/show?id=169c166430' target=_blank style='color:#2F92EE;'>#AACR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1664, encryptionId=169c166430, topicName=AACR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6b2714248200, createdName=Luyuxie_14, createdTime=Fri May 01 03:33:08 CST 2020, time=2020-05-01, status=1, ipAttribution=)]
2021-02-13 hb2008ye

#复发性#

61 0
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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1552018, encodeId=7fb0155201812, content=<a href='/topic/show?id=169c166430' target=_blank style='color:#2F92EE;'>#AACR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1664, encryptionId=169c166430, topicName=AACR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6b2714248200, createdName=Luyuxie_14, createdTime=Fri May 01 03:33:08 CST 2020, time=2020-05-01, status=1, ipAttribution=)]
2021-01-29 kord1982

#T淋巴细胞白血病#

81 0
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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1552018, encodeId=7fb0155201812, content=<a href='/topic/show?id=169c166430' target=_blank style='color:#2F92EE;'>#AACR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1664, encryptionId=169c166430, topicName=AACR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6b2714248200, createdName=Luyuxie_14, createdTime=Fri May 01 03:33:08 CST 2020, time=2020-05-01, status=1, ipAttribution=)]
2020-05-01 wetgdt

#淋巴细胞#

51 0
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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1552018, encodeId=7fb0155201812, content=<a href='/topic/show?id=169c166430' target=_blank style='color:#2F92EE;'>#AACR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1664, encryptionId=169c166430, topicName=AACR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6b2714248200, createdName=Luyuxie_14, createdTime=Fri May 01 03:33:08 CST 2020, time=2020-05-01, status=1, ipAttribution=)]
2020-05-01 10518094zz

#ACR#

77 0
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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1552018, encodeId=7fb0155201812, content=<a href='/topic/show?id=169c166430' target=_blank style='color:#2F92EE;'>#AACR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1664, encryptionId=169c166430, topicName=AACR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6b2714248200, createdName=Luyuxie_14, createdTime=Fri May 01 03:33:08 CST 2020, time=2020-05-01, status=1, ipAttribution=)]
2020-05-01 freve

#难治性#

89 0
[GetPortalCommentsPageByObjectIdResponse(id=2004413, encodeId=a2c72004413ea, content=<a href='/topic/show?id=54ebe8621cf' target=_blank style='color:#2F92EE;'>#结果公布#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78621, encryptionId=54ebe8621cf, topicName=结果公布)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=279b407, createdName=shanyongle, createdTime=Fri Mar 19 09:33:08 CST 2021, time=2021-03-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1781357, encodeId=85f11e813572c, content=<a href='/topic/show?id=8ce8405907' target=_blank style='color:#2F92EE;'>#CAR-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4059, encryptionId=8ce8405907, topicName=CAR-)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, 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encryptionId=f1b41665ac, topicName=AACR 2020)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Thu Aug 06 23:33:08 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1909813, encodeId=0e11190981305, 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=61, 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=Sat Feb 13 13:33:08 CST 2021, time=2021-02-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1967939, encodeId=bc63196e939b6, content=<a href='/topic/show?id=6e301800534' target=_blank style='color:#2F92EE;'>#T淋巴细胞白血病#</a>, beContent=null, objectType=article, 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2020-05-01 Luyuxie_14

#AACR#

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AACR 2020：CAR-T治疗复发性或难治性(R/R)急性T淋巴细胞白血病试验初步结果公布

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