I-GC203 lunyango olutsha lwe-TIL olungenazo iintsholongwane oluguqulwe yi-genetic vector oluphuhliswe lusebenzisa iqonga lokukhulisa iiseli ze-DeepTIL® zeJuncell Therapeutics kunye neqonga lokuguqula iiseli ze-NovaGMP®. I-DeepTIL® ivumela ii-TIL ukuba zibe namandla ngokwaneleyo kangangokuba akukho ndibaniselwano ye-IL-2 eya kufuneka emva kokufakwa, kwaye ubunzulu bonyango lwangaphambi kokuba lunyangwe bunokuba sezantsi. I-NovaGMP® iguqula iiseli ze-T ngokusebenza okuphezulu okufana ne-Lentiviral vector ngendlela engabizi kakhulu. I-GC203 yenzelwe i-interleukin-7 ezizidibanisayo, enokugcina i-stemness yeeseli ze-T zememori, isebenze iiseli zomzimba zangaphakathi kwaye iphephe ubuthi benkqubo yomzimba.
Abaphandi bavavanye i-GC203 kwizigulana ezifunyenwe zinomhlaza wesibeleko ophindaphindayo, ngaphandle kokudibana kokusetyenziswa kwe-IL-2 okanye i-aggressive lymphodepletion. Injongo yolu phononongo yayikukufumanisa ukhuseleko kunye nokusebenza kakuhle kolu nyango. Izigulane ezingama-20 zizonke zabhaliswa phakathi komhla we-09/2021 kunye nomhla we-01/2024 kuvavanyo lwe-open-label single-center, apho izigulana ezili-18 zavavanywa. Izigulana ezivavanywayo zazine-ECOG PS ye-1 (55.6%) okanye ezi-2 (44.4%) kwaye zafumana umyinge wezonyango ezi-5 zangaphambili zenkqubo (uluhlu: 2-11). Izigulana ezili-9 (50%) zazinezilonda zethumba ezi-3 nangaphezulu. Ubungakanani bezilonda ezijoliswe kuzo yayiyi-57 (uluhlu: 13-146) mm.
I-GC203 ibonise iziphumo ezithembisayo kwizigulana ezinomhlaza wesibeleko ophindaphindayo okanye osasazekayo. Iprofayili yokhuseleko iphuculwe kakhulu xa ithelekiswa nonyango lwe-TIL oluqhelekileyo, ngenxa yonyango oluphantsi kwamandla kunye nokususwa komxube we-IL-2. Uninzi lweZiganeko eziMbi (ii-AE) zazizibanga loku-1 okanye ibanga lesi-2 kwaye zinokuncitshiswa okanye zinyangwe ngonyango oluneempawu. Akukho siganeko sebanga lesi-5 esenzekayo. Ngomhla wokugqibela we-01/2024, iNqanaba leNjongo yoMpendulo (i-ORR) elivavanywe ngumphandi laliyi-33.3% (95% CI: 16.3 - 56.3), kuquka ne-11.1% yeNgxelo epheleleyo (CR). Izinga loLawulo lweZifo (i-DCR) laliyi-83.3% (95% CI, 60.8 - 94.2). Kwaye izinga lokusinda ngokupheleleyo (i-OS) leenyanga ezili-12 laliyi-68.8% (95% CI: 49.3 - 95.9). I-OS ephakathi yayingavuthwanga njengoko idatha yayinqunyulwa.
Ngowama-2023, uNksz H wangeniswa esibhedlele ngowama-2023 ngenxa yesisu.kunye nentlungu yesinqeEmva kokuhlolwa, kwafunyaniswa ukuba ii-lymph nodes ezininzi zande kwi-retroperitoneum, kwi-groin, nakwezinye iindawo, nto leyo eqinisekisa ukuxilongwa kwakhe komhlaza we-serous ovarian osezingeni eliphezulu. Ngoko ke uNksz H wenziwa i-chemotherapy, utyando, unyango lwe-immunotherapy, njl.njl., kodwa umphumo wawungafanelekanga, kwaye i-tumor yaphinda yavela.
Ngenxa yoko, uNksz H wathatha inxaxheba kuvavanyo lweklinikhi lwe-TIL cell therapy GC203, kwaye emva kwenyanga enye yonyango nge-GC203, ithumba lancipha ngama-37.3%.
Izigqibo: Ukufakwa kwe-GC203inokhuseleko olwamkelekileyo kunye nokusebenza kakuhle kwizigulane ze-OC ezihlala zibuyela umva ezinokukhetha unyango olulinganiselweyo.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
Email：myimmnet@163.com
Iireferensi
1.https://www.juncell.com/academic-achievements
2.https://www.juncell.com/company-news-76
3.https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5552
4.http://myimm.net/mianyizhiliao/2037.html
Ixesha leposi: Disemba-11-2024