I-Glioblastoma Multiforme (GBM) yenye yezona cancer zibulalayo, kwaye phantse zonke izigulana ziyaphinda zibuye ngokwemigangatho yonyango lwangoku lwe-GBM esandula ukuxilongwa. I-GBM ephindaphindayo (rGBM) ibonisa ukusinda okuphakathi kweenyanga ezingaphantsi kwezi-8 kunye neendlela zonyango ezimbalwa.
I-TX103 liyeza lonyango lweseli ye-CAR-T elijolise kwi-B7-H3, eliphuhliswe ngokuzimeleyo kwaye ligunyaziswe ngamalungelo omenzi aseTshayina nakwamanye amazwe. Iziphumo zokuqala zonyango lwe-TX103 kwi-gliomas eziphindaphindayo ziboniswe kwiNtlanganiso yoNyaka ye-American Society of Clinical Oncology (ASCO) ngo-2024.(IsiNgesi)NCT05241392）.
Iindlela: Olu luphando oluvulekileyo, olusebenzisa ingalo enye, olusebenzisa idosi "3+3″ kunye nophando olusebenzisa idosi ezininzi. Injongo ephambili yayikukuvavanya ukhuseleko kunye nedosi ephezulu enyamezelwayo. Iinjongo zesibini zaziquka iziphumo zokusinda, iimpendulo zethumba, iimpendulo ze-immunological, kunye neeparameter ze-pharmacokinetic. Izigulana ezineminyaka eli-18 ukuya kwengama-75 ubudala zibhalisiwe kwaye kuqinisekisiwe ukuba ziyaphinda zibuye ngokuskena umfanekiso kunye nokubonakaliswa kwe-B7-H3 >= 30% ngohlalutyo lwe-immunohistochemistry. I-TX103 yanikwa i-intracavity kunye/okanye ngaphakathi kwe-ventricular kwizigulana nge-Ommaya reservoir. I-TX103 yanikwa izigulana rhoqo ngeveki ezimbini kumjikelo ngamnye kumanqanaba edosi 1, 2, kunye ne-3 (iiseli ezingama-20, 60, 150 ezigidi, ngokulandelelana), kunye nemijikelo emine njengekhosi enye.
Iziphumo: Phakathi kukaMatshi 2022 noJanuwari 2024, izigulana ezili-13 zafumana ubuncinci i-TX103 enye ngaphakathi kwentloko, kunye nezigulana ezi-3, 4, kunye nezi-6 kumanqanaba edosi 1, 2, kunye ne-3, ngokulandelelana. Inani eliphakathi lemijikelo ye-infusion yayiyi-4 (Umn, Ubuninzi 1,9). Zonke izigulana zabandakanywa kuhlalutyo lokhuseleko, zityhila ukuba akukho tyhefu ithintela idosi okanye ukufa okunxulumene nonyango lwe-CAR-T. Zonke izigulana zafumana ubuncinane isiganeko esinye esibi (AE), kwaye ii-AE ezinxulumene nonyango (TRAEs) zaziquka i-cytokine release syndrome, uxinzelelo oluphezulu lwe-intracranial (ICP), intloko ebuhlungu, isifo sokuwa, izinga lokuncipha kwengqondo, ukuhlanza, kunye ne-pyrexia. Uninzi lwee-TRAE zazikwibanga loku-1-2, ngelixa ii-TRAE ezintathu zebanga lesi-3 zabonwa: ityala elinye lokwanda kwe-ICP kwinqanaba lesi-2 ledosi, ityala elinye lesifo sokuwa, kunye nelinye ityala lokuncipha kwenqanaba lokuqonda kwinqanaba lesi-3 ledosi. Ukusukela ngoJanuwari 2024, izigulana ezithandathu ezivela kumanqanaba edosi 1 kunye nelesi-2 zazifanelekile kuvavanyo lokusinda lweenyanga ezili-12; Izinga lokusinda lilonke leenyanga ezili-12 (OS) yayiyi-83.3% (95% CI: 58.3% ~ 100%), kwaye i-OS ephakathi yayiyi-20.3 ngenyanga (95% CI: 20.3 ~ ayifikelelwanga). Abaguli ababini kwabathathu abakwinqanaba ledosi yesi-2 bafumene iimpendulo ezingaphelelanga nezipheleleyo, ngokulandelelana. Emva kokunikwa kwe-CAR-T, ukwanda okukhulu kwii-cytokines, kuquka i-IL-6 kunye ne-IFN-γ, kunye namanani aphezulu ekopi ye-CAR gene abonwa kulwelo lwe-cerebrospinal, ngelixa kuphela ukuphakama okuncinci okuphawulwe kwigazi elingaphandle.
Izigqibo: Kolu vavanyo, ukunyanga i-rGBM nge-TX103 kuthathwa njengokukhuselekileyo nokunyamezelwa. Ezi ziphumo zexeshana zixhasa uphando oluthe kratya olusebenzisa i-TX103 ukuphucula iziphumo zokusinda kwizigulane ezine-rGBM.
Okwangoku, kukho ezinye iimvavanyo ezininzi zeklinikhi ze-CAR-T eTshayina, kwaye zikhangela izigulane. Ukuze ufumane iingcebiso ngamayeza amatsha kunye netekhnoloji, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
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Ixesha lokuthumela: Disemba-09-2024