{"id":60241,"date":"2018-11-27T01:00:00","date_gmt":"2018-12-07T02:54:56","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/85ac2bac93\/"},"modified":"2018-12-07T10:54:58","modified_gmt":"2018-12-07T02:54:58","slug":"85ac2bac93","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/60241\/","title":{"rendered":"CAR-T\u56fd\u5185\u8fdb\u7a0b\u7f13\u6162\uff0c\u56db\u5bb6\u5f00\u5c55\u6b63\u89c4\u4e34\u5e8a"},"content":{"rendered":"
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\u4f17\u6240\u5468\u77e5\uff0c\u6211\u56fd\u53ef\u80fd\u662f\u5f53\u524d\u4e16\u754c\u4e0a\u505a\u7ec6\u80de\u6cbb\u7597\u7814\u7a76\u6700\u591a\u7684\u56fd\u5ea6\uff08200\u591a\u5bb6\u7ec6\u80de\u6cbb\u7597\u516c\u53f8\uff09\uff0c\u79d1\u7814\u4eba\u5458\u548c\u8d44\u672c\u90fd\u5230\u4e86\u75f4\u8ff7\u7684\u7a0b\u5ea6\u3002<\/span>CAR-T<\/span>\u867d\u706b\uff0c\u4f46\u56fd\u5185\u8fdb\u7a0b\u7f13\u6162\uff0c\u76ee\u524d\u63d0\u4ea4\u6b63\u89c4<\/span>IND<\/span>\u7684\u57fa\u672c\u662f\u590d\u53d1\u96be\u6cbb\u7684\u8840\u6db2\u80bf\u7624\u3002<\/span><\/span><\/p>\n<\/section>\n<\/section>\n

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\u4e00<\/span>\u5173\u4e8e\u6dcb\u5df4\u7624<\/strong><\/p>\n<\/section>\n<\/section>\n

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1.\u6dcb\u5df4\u7624\u662f\u8d77\u6e90\u4e8e\u6dcb\u5df4\u7ed3\u548c\/<\/span>\u6216\u7ed3\u5916\u6dcb\u5df4\u7ec4\u7ec7\u7684\u4e00\u7ec4\u5f02\u8d28\u6027\u80bf\u7624\uff0c\u4e00\u822c\u5206\u4e3a\u970d\u5947\u91d1\u6dcb\u5df4\u7624\uff08Hodgkin ‘s Lymphoma<\/span>\uff0cHL<\/span>\uff09\u548c\u975e\u970d\u5947\u91d1\u6dcb\u5df4\u7624\uff08Non-Hodgkin’s Lymphoma<\/span>\uff0cNHL<\/span>\uff09\u4e24\u5927\u7c7b\uff0c\u5176\u4e2dNHL<\/span>\u4e3b\u8981\u6765\u6e90\u4e8eB <\/span><\/span>\u6dcb\u5df4\u7ec6\u80de\uff0c\u5c11\u90e8\u5206\u6765\u6e90\u4e8e <\/span>T <\/span><\/span>\u6dcb\u5df4\u7ec6\u80de\u6216\u81ea\u7136\u6740\u4f24\u7ec6\u80de\uff0cB <\/span><\/span>\u7ec6\u80de <\/span>NHL <\/span><\/span>\u662f\u6210\u4eba\u6076\u6027\u80bf\u7624\u4e2d\u7684\u5e38\u89c1\u7c7b\u578b\u3002<\/span><\/p>\n


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2.\u5f25\u6f2b\u6027\u5927B<\/span>\u7ec6\u80de\u6dcb\u5df4\u7624\uff08DLBCL<\/span>\uff09\u662f\u4e00\u79cd\u4fb5\u88ad\u6027\u4e9a\u578b\uff0c\u662fB<\/span>\u7ec6\u80deNHL<\/span>\u4e2d\u6700\u5e38\u89c1\u7684\u4e9a\u578b\uff0c\u5176\u53d1\u75c5\u7387\u5360\u975e\u970d\u5947\u91d1\u6dcb\u5df4\u7624\uff08NHL<\/span>\uff09\u768431%~ 34%<\/span>\uff0c\u5728\u4e9a\u6d32\u56fd\u5bb6\u4e00\u822c\u5927\u4e8e40%<\/span>\u3002\u539f\u53d1\u6027\u7eb5\u9694B<\/span>\u7ec6\u80de\u6dcb\u5df4\u7624\uff08PMBCL<\/span>\uff09\u662fDLBCL <\/span><\/span>\u7684\u4e9a\u578b\uff0c\u8be5\u4e9a\u578b\u60a3\u8005\u7ea6\u5360DLBCL<\/span>\u786e\u8bca\u60a3\u8005\u603b\u6570\u76842%~ 4%<\/span>\u3002\u6ee4\u6ce1\u6027\u6dcb\u5df4\u7624\uff08FL<\/span>\uff09\u662fB<\/span>\u7ec6\u80deNHL<\/span>\u6700\u5e38\u89c1\u7684\u60f0\u6027\u6dcb\u5df4\u7624\u4e9a\u578b\uff0c\u5728\u4e2d\u56fd\u7ea6\u5360\u6240\u6709 <\/span>NHL <\/span><\/span>\u603b\u91cf\u76846.3%<\/span>\u3002<\/span><\/p>\n


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\u4e8c<\/span>\u591a\u53d1\u9aa8\u9ad3\u7624<\/strong><\/p>\n<\/section>\n

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\u56fd\u9645\u9aa8\u9ad3\u7624\u7ec4\u7ec7\uff08Myeloma.org\uff09\u6570\u636e\u663e\u793a\uff0c\u5168\u7403\u7ea6\u670975\u4e07\u540d\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u60a3\u8005\uff0c\u7b2c\u4e8c\u5927\u8840\u6db2\u80bf\u7624\u75be\u75c5\u3002\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u662f\u6211\u56fd\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u7684\u53d1\u75c5\u7387\u7ea6\u4e3a2~3\/10 \u4e07\uff0c\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u7684\u53d1\u75c5\u4eba\u6570\u5728\u5e38\u89c1\u8840\u6db2\u6076\u6027\u80bf\u7624\u7684\u53d1\u75c5\u603b\u4eba\u6570\u4e2d\u7ea6\u536013%\uff08\u6839\u636eCancer Statistics Review\uff09\uff0c\u521d\u6b65\u9884\u8ba1\u6211\u56fd\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u603b\u60a3\u8005\u8d85\u8fc710\u4e07\u4eba\u3002GLOBOCAN 2018\u62a5\u9053\u6211\u56fd\u6bcf\u5e74\u65b0\u589eMM\u60a3\u800520,066\uff0c\u6b7b\u4ea114,655\uff0c5\u5e74\u60a3\u75c5\u7387\u4e3a44,643\u3002<\/span><\/p>\n


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\u4e09<\/span>\u56fd\u5185\u6b63\u5f0f\u83b7\u6279\u5e76\u5f00\u5c55\u4e34\u5e8a\u7684\u4f01\u4e1a<\/strong><\/p>\n<\/section>\n

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\"CAR-T\u56fd\u5185\u8fdb\u7a0b\u7f13\u6162\uff0c\u56db\u5bb6\u5f00\u5c55\u6b63\u89c4\u4e34\u5e8a\"<\/p>\n<\/section>\n<\/section>\n

1.\u836f\u660e\u5de8\u8bfa\uff1a<\/strong><\/span><\/p>\n


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2018\u5e74<\/span>6\u6708<\/span>27\u65e5<\/span><\/span><\/span>\uff0c\u4e0a\u6d77\u836f\u660e\u5de8\u8bfa\u751f\u7269\u79d1\u6280\u6709\u9650\u516c\u53f8\u53ca\u5176\u5173\u8054\u516c\u53f8\u4e0a\u6d77\u660e\u805a\u751f\u7269\u79d1\u6280\u6709\u9650\u516c\u53f8\u8868\u793a\uff0c\u660e\u805a\u751f\u7269CAR-T\u4ea7\u54c1JWCAR029\u7684IND\u7533\u8bf7\u83b7\u5f97\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u6279\u51c6\uff0c\u56fd\u5185\u9996\u4e2a\u83b7\u51c6\u4e34\u5e8a\u7684\u4ee5CD19\u4e3a\u9776\u70b9\u7684CAR-T\u4ea7\u54c1\u3002<\/span><\/p>\n


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\u836f\u660e\u5de8\u8bfa\u5728\u82cf\u5dde\u5de5\u4e1a\u56ed\u6b63\u5728\u5efa\u8bbecGMP\u7ec6\u80de\u6cbb\u7597\u5546\u4e1a\u5316\u751f\u4ea7\u5de5\u5382\u3002<\/span><\/p>\n


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2.\u590d\u661f\u51ef\u7279\uff1a<\/strong><\/span><\/p>\n


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2018\u5e749<\/span>\u6708<\/span><\/span>\u590d\u661f\u51ef\u7279CAR-T\u4ea7\u54c1\u76ca\u57fa\u5229\u4ed1\u8d5b\uff08FKC876\uff09\u7528\u4e8e\u590d\u53d1\u96be\u6cbb\u6027\u5927B\u7ec6\u80de\u6dcb\u5df4\u7624\u6cbb\u7597\u7684\u4e34\u5e8a\u8bd5\u9a8c\u83b7\u5f97\u56fd\u5bb6\u836f\u76d1\u5c40\uff08NMPA\uff09\u6279\u51c6\u3002<\/span><\/p>\n


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\u590d\u661f\u51ef\u7279-\u8bc4\u4ef7<\/span>FKC876\u6cbb\u7597\u590d\u53d1\u96be\u6cbb\u6027\u4fb5\u88ad\u6027\u975e\u970d\u5947\u91d1\u6dcb\u5df4\u7624\uff08NHL<\/span>\uff09\u7684\u5b89\u5168\u6027\u548c\u7597\u6548\u7684\u5f00\u653e\u6027\u4e34\u5e8a\u7814\u7a76<\/span><\/strong><\/span>2018\u5e7410\u6708\u901a\u8fc7\u9057\u4f20\u529e\u5ba1\u6279\u3002(\u534e\u4e2d\u79d1\u6280\u5927\u5b66\u540c\u6d4e\u533b\u5b66\u9662\u9644\u5c5e\u534f\u548c\u533b\u9662 )<\/span><\/p>\n


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FKC876 (\u7f8e\u56fd\u5546\u54c1\u540d\u79f0Yescarta)<\/span><\/span><\/strong><\/span>\u662f\u590d\u661f\u51ef\u72792017\u5e74\u521d\u4ece\u7f8e\u56fd Kite Pharma \u5f15\u8fdb\u7684 CAR-T \u7ec6\u80de\u514d\u75ab\u6cbb\u7597\u4ea7\u54c1\u3002\u590d\u661f\u51ef\u7279\u83b7\u5f97\u4e86 Kite \u5173\u4e8e\u672c\u54c1\u7684\u5168\u90e8\u6280\u672f\u6388\u6743\uff0c\u5e76\u62e5\u6709\u4e2d\u56fd\u5305\u62ec\u9999\u6e2f\u3001\u6fb3\u95e8\u7684\u5546\u4e1a\u5316\u6743\u5229\u3002Yescarta \u5df2\u4e8e2017 \u5e7410 \u670818 \u65e5\u83b7\u5f97\u7f8e\u56fd FDA \u6279\u51c6\u4e0a\u5e02\uff0c\u6cbb\u7597\u590d\u53d1\u96be\u6cbb\u6027\u5927B\u7ec6\u80de\u6dcb\u5df4\u7624\u60a3\u8005\uff0c\u662f\u7f8e\u56fd FDA \u6279\u51c6\u7684\u9996\u6b3e\u9488\u5bf9\u7279\u5b9a\u975e\u970d\u5947\u91d1\u6dcb\u5df4\u7624\u7684CAR-T\u7ec6\u80de\u836f\u7269\u30022018 \u5e748 \u670827 \u65e5\uff0cYescarta \u6210\u4e3a\u6b27\u6d32\u7b2c\u4e00\u6279\u83b7\u6279\u51c6\u4e0a\u5e02\u7684CAR-T\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\uff0c\u7528\u4e8e\u6cbb\u7597\u590d\u53d1\u6216\u96be\u6cbb\u6027DLBCL\u7b49\u3002<\/span><\/p>\n


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3.\u6052\u6da6\u8fbe\u751f\uff1a<\/strong><\/span><\/p>\n


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2018\u5e7411\u670813\u65e5\uff0c\u6052\u6da6\u8fbe\u751f\u6297\u4ebaCD19 T\u7ec6\u80de\u6ce8\u5c04\u6db2\uff08CD19 CAR-T\u7ec6\u80de\uff09\u6cbb\u7597\u590d\u53d1\/\u96be\u6cbb\u6027CD19\u9633\u6027\u5f25\u6f2b\u5927B\u7ec6\u80de\u6dcb\u5df4\u7624\u548c\u6ee4\u6ce1\u6027\u6dcb\u5df4\u7624\u7684I\u671f\u4e34\u5e8a\u7814\u7a76\uff08\u7814\u7a76\u7f16\u53f7HRAIN01-NHL01\uff09\uff0c\u5df2\u5728\u590d\u65e6\u5927\u5b66\u9644\u5c5e\u4e2d\u5c71\u533b\u9662\u8840\u6db2\u79d1\u5218\u6f8e\u4e3b\u4efb\u53ca\u5176\u56e2\u961f\u7684\u6307\u5bfc\u4e0b\uff0c\u5b8c\u6210\u4e86\u9996\u4f8b\u60a3\u8005\u5165\u7ec4\u53ca\u5355\u4e2a\u6838\u7ec6\u80de\u91c7\u96c6\u3002<\/span><\/p>\n


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\u7814\u7a76\u4e3a\u5355\u4e2d\u5fc3\u3001\u5355\u81c2\u3001\u5f00\u653e\u3001\u5242\u91cf\u9012\u589e\u7684I\u671f\u4e34\u5e8a\u7814\u7a76\uff0c\u56fd\u5185\u542f\u52a8\u7684CAR-T\u7ec6\u80de\u6cbb\u7597\u6dcb\u5df4\u7624\u7684\u6b63\u89c4\u65b0\u836f\u6ce8\u518c\u4e34\u5e8a\u8bd5\u9a8c\uff08IND\uff09\u7814\u7a76\u3002<\/span><\/p>\n


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2018\u5e746<\/span>\u670828<\/span>\u65e5<\/span><\/span>\u83b7\u5f97\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u7684<\/span>\u4e34\u5e8a\u8bd5\u9a8c\u6279\u4ef6<\/span><\/span>\uff0c\u5e76\u4e8e2018\u5e74<\/span>10\u67088<\/span>\u65e5<\/span><\/span>\u83b7\u5f97<\/span>\u4eba\u7c7b\u9057\u4f20\u8d44\u6e90\u7ba1\u7406\u529e\u516c\u5ba4\u6279\u4ef6<\/span>\u30022018\u5e7410<\/span>\u670825<\/span>\u65e5<\/span><\/span>\u5728\u590d\u65e6\u5927\u5b66\u9644\u5c5e\u4e2d\u5c71\u533b\u9662\u6b63\u5f0f\u542f\u52a8\u3002<\/span><\/p>\n


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4. \u5357\u4eac\u4f20\u5947\u751f\u7269<\/strong><\/span><\/p>\n


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\uff081\uff09\u57282017\u5e7412\u670811\u65e5CDE\u6570\u636e\u663e\u793a\uff0c\u5357\u4eac\u4f20\u5947\u751f\u7269\u79d1\u6280\u6709\u9650\u516c\u53f8\u7533\u62a5\u7684LCAR-B38MCAR-T\u7ec6\u80de\u81ea\u4f53\u56de\u8f93\u5236\u5242\u65b0\u836f\u4e34\u5e8a\u7533\u8bf7\u5df2\u88ab\u6b63\u5f0f\u53d7\u7406\uff0c\u8fd9\u662f\u6211\u56fd\u9996\u4e2a\u83b7\u5f97\u53d7\u7406\u7684CAR-T\u7597\u6cd5\u3002<\/span><\/p>\n


<\/p>\n

\uff082\uff092018\u5e743\u6708\uff0cLCAR-B38MCAR-T\u7ec6\u80de\u81ea\u4f53\u56de\u8f93\u5236\u5242\u83b7\u6279\u4e34\u5e8a\u3002<\/span><\/p>\n


<\/p>\n

\uff083\uff092018\u5e7411\u6708\uff0c\u83b7\u5f97\u4eba\u7c7b\u9057\u4f20\u8d44\u6e90\u884c\u653f\u8bb8\u53ef\u3002<\/span><\/p>\n


<\/p>\n\n\n\n
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\u56fd\u79d1\u9057\u529e\u5ba1\u5b57\u30142018\u3015<\/span>2035\u53f7<\/span><\/span><\/p>\n<\/td>\n

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2018\uff08<\/span>21\uff09<\/span><\/span><\/p>\n<\/td>\n

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\u4e00\u9879\u8bc4\u4ef7\u9776\u5411BCMA\u7684<\/span>LCAR-B38M\u5d4c\u5408\u6297\u539f\u53d7\u4f53<\/span>T\u7ec6\u80de\uff08<\/span>CAR-T\uff09\u7597\u6cd5\u6cbb\u7597\u4e2d\u56fd\u590d\u53d1\u6216\u96be\u6cbb\u6027\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u53d7\u8bd5\u8005\u7684<\/span>II\u671f\u5f00\u653e\u6027\u7814\u7a76<\/span><\/span><\/p>\n<\/td>\n

\n

\u4e0a\u6d77\u4ea4\u901a\u5927\u5b66\u533b\u5b66\u9662\u9644\u5c5e\u745e\u91d1\u533b\u9662<\/span><\/p>\n<\/td>\n

\n

\u5357\u4eac\u4f20\u5947\u751f\u7269\u79d1\u6280\u6709\u9650\u516c\u53f8\u3001\u6768\u68ee\u7814\u53d1\u6709\u9650\u516c\u53f8\u3001\u5f3a\u751f\uff08\u4e2d\u56fd\uff09\u6295\u8d44\u6709\u9650\u516c\u53f8<\/span><\/p>\n<\/td>\n

\n

2018\u5e74<\/span>11\u6708<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n


<\/p>\n

\uff084\uff09\u76f8\u5173\u4e34\u5e8a\u8bd5\u9a8c\u4fe1\u606f<\/span><\/p>\n


<\/p>\n\n\n\n\n\n\n\n
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\u767b\u8bb0\u53f7\uff1a<\/span><\/p>\n<\/td>\n

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CTR20181007<\/span><\/p>\n<\/td>\n<\/tr>\n

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\u9002\u5e94\u75c7\uff1a<\/span><\/p>\n<\/td>\n

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\u591a\u53d1\u6027\u9aa8\u9ad3\u7624<\/span><\/p>\n<\/td>\n<\/tr>\n

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\u8bd5\u9a8c\u901a\u4fd7\u9898\u76ee\uff1a<\/span><\/p>\n<\/td>\n

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\u9776\u5411BCMA LCAR-B38M CAR-T<\/span>\u6cbb\u7597\u4e2d\u56fd\u590d\u53d1\u6216\u96be\u6cbb\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u53d7\u8bd5\u8005\u7814\u7a76<\/span><\/p>\n<\/td>\n<\/tr>\n

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\u8bd5\u9a8c\u4e13\u4e1a\u9898\u76ee\uff1a<\/span><\/p>\n<\/td>\n

\n

\u4e00\u9879\u8bc4\u4ef7\u9776\u5411BCMA<\/span>\u7684LCAR-B38M<\/span>\u5d4c\u5408\u6297\u539f\u53d7\u4f53T<\/span>\u7ec6\u80de\uff08CAR-T<\/span>\uff09\u7597\u6cd5\u6cbb\u7597\u4e2d\u56fd\u590d\u53d1\u6216\u96be\u6cbb\u6027\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\uff08MM<\/span>\uff09\u53d7\u8bd5\u8005\u7684II<\/span>\u671f\u5f00\u653e\u6027\u7814\u7a76<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u8bd5\u9a8c\u65b9\u6848\u7f16\u53f7\uff1a<\/span><\/p>\n<\/td>\n

\n

68284528MMY2002;\u4e2d\u6587\u7248\u672c\u65e5\u671f\uff1a2018<\/span>\u5e745<\/span>\u67083<\/span>\u65e5<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n


<\/p>\n

\u4ee5\u4e0a\u4e3a\u4e00\u9879\u5355\u81c2\u975e\u968f\u673a\u5316\u5f00\u653e\u7684\u56fd\u5185II\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0cPI\u4e3a\u4e0a\u6d77\u4ea4\u901a\u5927\u5b66\u533b\u5b66\u9662\u9644\u5c5e\u745e\u91d1\u533b\u9662\uff0c\u9648\u8d5b\u5a1f\u9662\u58eb\u3002<\/span><\/p>\n


<\/p>\n

\u672c\u6b21\u56fd\u5185\u8bd5\u9a8c\u62db\u52df:60\u4eba\u3002<\/span><\/p>\n


<\/p>\n

\u4e34\u5e8a\u4e3b\u8981\u7ec8\u70b9\uff0c\u6709\u6548\u6027\u6307\u6807\uff1a\u6839\u636e\u56fd\u9645\u9aa8\u9ad3\u7624\u5de5\u4f5c\u7ec4\uff08IMWG\uff09\u7684\u7597\u6548\u6807\u51c6\u8bc4\u4f30<\/span>ORR\uff08\u81f3\u5c11\u8fbe\u5230PR<\/span>\u6216\u66f4\u4f73\u7597\u6548\uff09\uff0c\u9996\u6b21\u8f93\u6ce8\u540e\u81f3\u5c112<\/span>\u5e74<\/span>\u3002<\/span><\/p>\n


<\/p>\n\n\n\n\n\n\n
\n

\u5e8f\u53f7<\/span><\/p>\n<\/td>\n

\n

\u540d\u79f0<\/span><\/p>\n<\/td>\n

\n

\u7528\u6cd5<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

1<\/span><\/p>\n<\/td>\n

\n

LCAR-B38M\u7ec6\u80de\u5236\u5242<\/span><\/p>\n<\/td>\n

\n

\u6ce8\u5c04\u5242\uff1b\u89c4\u683c70ml\/<\/span>\u888b\uff080.75<\/span>\u00d710^6<\/span>\u4e2a\u6d3b\u7684CAR<\/span>\u9633\u6027T<\/span>\u7ec6\u80de\/kg<\/span>\uff09\uff1b\u9759\u8109\u6ce8\u5c04\uff0c\u4e00\u6b2170ml<\/span>\uff080.75<\/span>\u00d710^6<\/span>\u4e2a\u6d3b\u7684CAR<\/span>\u9633\u6027T<\/span>\u7ec6\u80de\/kg<\/span>\uff09\uff0c\u7528\u836f\u65f6\u7a0b\uff1a\u53ea\u6ce8\u5c04\u4e00\u6b21\u3002\u5242\u91cf\u6c34\u5e731<\/span>\u7ec4\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

2<\/span><\/p>\n<\/td>\n

\n

LCAR-B38M\u7ec6\u80de\u5236\u5242<\/span><\/p>\n<\/td>\n

\n

\u6ce8\u5c04\u5242\uff1b\u89c4\u683c70ml\/<\/span>\u888b\uff080.3<\/span>\u00d710^6<\/span>\u4e2a\u6d3b\u7684CAR<\/span>\u9633\u6027T<\/span>\u7ec6\u80de\/kg<\/span>\uff09\uff1b\u9759\u8109\u6ce8\u5c04\uff0c\u4e00\u6b2170ml<\/span>\uff080.3<\/span>\u00d710^6<\/span>\u4e2a\u6d3b\u7684CAR<\/span>\u9633\u6027T<\/span>\u7ec6\u80de\/kg<\/span>\uff09\uff0c\u7528\u836f\u65f6\u7a0b\uff1a\u53ea\u6ce8\u5c04\u4e00\u6b21\u3002\u5242\u91cf\u6c34\u5e73-1<\/span>\u7ec4\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

3<\/span><\/p>\n<\/td>\n

\n

LCAR-B38M\u7ec6\u80de\u5236\u5242<\/span><\/p>\n<\/td>\n

\n

\u6ce8\u5c04\u5242\uff1b\u89c4\u683c70ml\/<\/span>\u888b\uff082.25<\/span>\u00d710^6<\/span>\u4e2a\u6d3b\u7684CAR<\/span>\u9633\u6027T<\/span>\u7ec6\u80de\/kg<\/span>\uff09\uff1b\u9759\u8109\u6ce8\u5c04\uff0c\u4e00\u6b2170ml<\/span>\uff082.25<\/span>\u00d710^6<\/span>\u4e2a\u6d3b\u7684CAR<\/span>\u9633\u6027T<\/span>\u7ec6\u80de\/kg<\/span>\uff09\uff0c\u7528\u836f\u65f6\u7a0b\uff1a\u53ea\u6ce8\u5c04\u4e00\u6b21\u3002\u5242\u91cf\u6c34\u5e732<\/span>\u7ec4\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n


<\/p>\n


<\/p>\n

\n

\u56db<\/span>\u8bfa\u534e\u3001\u897f\u6bd4\u66fc<\/strong><\/p>\n<\/section>\n

 <\/p>\n


<\/p>\n

2018\u5e749 \u6708 27 \u65e5\uff0c CBMG(\u897f\u6bd4\u66fc\u751f\u7269)\u4e0e\u8bfa\u534e\u8fbe\u6210\u6218\u7565\u8bb8\u53ef\u548c\u5408\u4f5c\u534f\u8bae\uff0c\u8d1f\u8d23\u5728\u4e2d\u56fd\u751f\u4ea7\u548c\u4f9b\u5e94 CAR-T \u7ec6\u80de\u6cbb\u7597\u836f\u7269 Kymriah(tisagenlecleucel)\u3002\u540c\u65f6\u4ee5\u6bcf\u80a1 27.43 \u7f8e\u5143\u7684\u4ef7\u683c\u5411\u8bfa\u534e\u516c\u53f8\u51fa\u552e\u7ea6 9% \u7684\u80a1\u6743\uff0c\u897f\u6bd4\u66fc\u83b7\u5f97 4,000 \u4e07\u7f8e\u5143\u7684\u80a1\u6743\u6536\u8d2d\u6b3e\u3002<\/span><\/p>\n


<\/p>\n

CBMG \u5c06\u4e3b\u8981\u8d1f\u8d23Kymriah(tisagenlecleucel)\u5236\u9020\u5de5\u827a\uff0c\u8bfa\u534e\u516c\u53f8\u5c06\u4e3b\u8981\u8d1f\u8d23\u4e2d\u56fd\u7684\u5206\u9500\u3001\u76d1\u7ba1\u548c\u5546\u4e1a\u5316\u65b9\u9762\u7684\u5de5\u4f5c\u3002<\/span><\/p>\n


<\/p>\n

\n
\n

\u4e94<\/span>2018\u5e74\u90e8\u5206\u7533\u62a5IND\u7684\u7ec6\u80de\u7597\u6cd5\u4e00\u89c8<\/strong><\/p>\n<\/section>\n

\n
\n


<\/p>\n

\"CAR-T\u56fd\u5185\u8fdb\u7a0b\u7f13\u6162\uff0c\u56db\u5bb6\u5f00\u5c55\u6b63\u89c4\u4e34\u5e8a\"<\/p>\n


<\/p>\n<\/section>\n

\n

\u516d<\/span>\u56fd\u5185CART\u4ea7\u4e1a\u8fdb\u7a0b\u7f13\u6162\u53ef\u80fd\u539f\u56e0<\/strong><\/p>\n<\/section>\n<\/section>\n

\n


<\/p>\n\n\n\n\n\n\n\n
\n

\u76d1\u7ba1<\/span><\/strong><\/p>\n<\/td>\n

\n

\u6b64\u524d\u56fd\u5bb6\u836f\u76d1\u5c40\u548c\u536b\u5065\u59d4\u5f52\u5c5e\u95ee\u9898<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

IND<\/span><\/strong><\/p>\n<\/td>\n

\n

\u7533\u62a5\u4f01\u4e1a\u8d44\u6599\uff0c\u6838\u67e5\u4e0d\u5c3d\u5982\u4eba\u610f<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u4ea7\u4e1a\u5316<\/span><\/strong><\/p>\n<\/td>\n

\n

\u7ec6\u80de\u6cbb\u7597cGMP<\/span>\u5de5\u5382\u6b63\u5728\u5efa\u8bbe\u4e2d<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u4eba\u624d<\/span><\/strong><\/p>\n<\/td>\n

\n

\u7f3a\u4e4f\u505a\u836f\u7ecf\u9a8c\u7684\u4eba\u624d\uff0c\u6d89\u53ca\u5de5\u827a\u5f00\u53d1\uff0c\u4e25\u683c\u8d28\u91cf\u7ba1\u63a7CMC<\/span>\u7b49<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u4e34\u5e8a<\/span><\/strong><\/p>\n<\/td>\n

\n

\u4e34\u5e8a\u4e0d\u89c4\u8303\uff0c\u5c24\u5176\u662f\u4ed8\u8d39\u6cbb\u7597\uff0c\u7814\u7a76\u8005\u53d1\u8d77\u7684\u4e5f\u6709\u5f85\u9a8c\u8bc1<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n


<\/p>\n<\/section>\n

\n

1.2017\u5e7412\u670822\u65e5\uff0cNMPA\u51fa\u53f0\u300a\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u7814\u7a76\u4e0e\u8bc4\u4ef7\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\uff08\u8bd5\u884c\uff09\u3002<\/span><\/p>\n


<\/p>\n

2.2018\u5e746\u67085\u65e5\uff0c\u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u68c0\u5b9a\u7814\u7a76\u9662\u53d1\u5e03\u300aCAR-T\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u8d28\u91cf\u63a7\u5236\u68c0\u6d4b\u7814\u7a76\u53ca\u975e\u4e34\u5e8a\u7814\u7a76\u8003\u8651\u8981\u70b9\u300b\u3002<\/span><\/p>\n


<\/p>\n

3. 2018\u5e749\u67087\u65e5\uff0c\u4e2d\u56fd\u533b\u836f\u751f\u7269\u6280\u672f\u534f\u4f1a\u5d4c\u5408\u6297\u539f\u53d7\u4f53\u4fee\u9970T\u7ec6\u80de\uff08CAR-T\u7ec6\u80de\uff09\u5236\u5242\u5236\u5907\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u53c2\u8003\uff1a<\/span><\/strong><\/p>\n

https:\/\/www.lymphoma.org\/<\/span>\uff1b<\/span><\/p>\n

https:\/\/www.lymphoma.org\/wp-content\/uploads\/2017\/07\/LRF_FACTSHEET_NON_HODGKIN_LYMPHOMA.pdf<\/span>\uff1b<\/span><\/p>\n

NMPA\/CDE\uff1b<\/span><\/p>\n

\u836f\u878d\u6570\u636e\uff0cPharnex  Datamonitor;<\/span><\/p>\n

FDA\/EMA\uff1b<\/span><\/p>\n

\u76f8\u5173\u516c\u53f8\u516c\u5f00\u62ab\u9732\u7b49\u3002<\/span><\/p>\n

\n
\n


<\/p>\n<\/section>\n<\/section>\n

\"CAR-T\u56fd\u5185\u8fdb\u7a0b\u7f13\u6162\uff0c\u56db\u5bb6\u5f00\u5c55\u6b63\u89c4\u4e34\u5e8a\"<\/p>\n

\u5728\u6587\u7ae0\u540e\u7559\u8a00\uff0c\u5408\u9002\u7684\u53ef\u6dfb\u52a0Research\u533b\u836f\u4ebaDaniel\u5fae\u4fe1\u3002<\/p>\n


<\/p>\n

\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section><\/div>\n","protected":false},"excerpt":{"rendered":"

\u4f17\u6240\u5468\u77e5\uff0c\u6211\u56fd\u53ef\u80fd\u662f\u5f53\u524d\u4e16\u754c\u4e0a\u505a\u7ec6\u80de\u6cbb\u7597\u7814\u7a76\u6700\u591a\u7684\u56fd\u5ea6\uff08200\u591a\u5bb6\u7ec6\u80de\u6cbb\u7597\u516c\u53f8\uff09\uff0c\u79d1\u7814\u4eba\u5458\u548c\u8d44\u672c\u90fd\u5230\u4e86\u75f4\u8ff7\u7684\u7a0b […]<\/p>\n","protected":false},"author":1,"featured_media":60242,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/60241"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=60241"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/60241\/revisions"}],"predecessor-version":[{"id":60246,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/60241\/revisions\/60246"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/60242"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=60241"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=60241"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=60241"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}