Unyango lwe-TIL (GT101)

I-GT101 lunyango lweeseli oluzenzekelayo olwenziwe nge-TIL eyandisiweyo nevuselelwe kwithumba lesigulana. Olu nyango luqhutywa ngokuqokelela izicubu zethumba kwizigulana kunye nokukhupha i-TIL. I-TIL ekhutshiweyo iya kuthi emva koko inyuswe kusetyenziswa iqonga lokuvelisa eliyi-Grit Bio i-StemTexp® kwaye ibuyiselwe kwizigulana ukulwa nethumba.

Ngowama-2024Intlanganiso Yonyaka ye-American Society of Clinical Oncology (ASCO),Idatha exeliweyo kwizigulane ezili-14 ezine-tumor eqinileyo ezithathe inxaxheba kuphononongo lwe-GT101. Olu vavanyo lwenzelwe isiphelo esiphambili sokuvavanya i-DLT kunye nokuchonga iprofayili yokhuseleko lwe-GT101 kwizigulane ezine-tumor eqinileyo ezilinganiswa ngokweziganeko ze-Grade ≥ 3 zonyango-ezivelayo iziganeko ezimbi (TEAEs). Isiphelo sesibini yayikukuvavanya iiparameter zokusebenza kakuhle kuquka izinga lokuphendula ngokubanzi (ORR), izinga lokulawula isifo (DCR), ukusinda okungenankqubela phambili (PFS), ubude bempendulo (DOR), kunye nokusinda ngokubanzi (OS) ngokwe-RECIST v1.1.

Iziphumo: Ukusukela nge-10 kaNovemba ngo-2023, iqela lezigulana ezili-14 lafumana unyango oluphakathi kweminyaka engama-46.9 kunye nomlinganiselo wemigca engama-2.6 yonyango lwangaphambili. Emva konyango oluqhelekileyo olusekelwe kwi-FC, izigulana zanikwa i-GT101 kwiidosi ≥ 5×109 iiseli ezinedosi ephakathi yeeseli ezingama-3.7×1010, kulandele ukunikezelwa kwe-IL-2 enedosi ephezulu. Uninzi lwee-AE zeBanga ≥ 3 ezibonweyo zazinxulumene nonyango lwe-FC kunye ne-IL-2, kubandakanya ukwehla kwenani le-lymphocyte, ukwehla kwenani leeseli ezimhlophe zegazi, ukwehla kwenani le-neutrophil, i-anemia, i-pyrexia kunye nokwehla kwenani leeplatelet. Uninzi lwezi AE zabuyiselwa kwiintsuku ezili-14, ngelixa ezimbalwa zehliswa kwi-≤ iBanga lesi-2 kwiiveki ezi-4. Phakathi kwezigulana ezili-14 ezibhalisiweyo kwiimpawu ezahlukeneyo (umhlaza weeseli ezincinci-zemiphunga, i-melanoma, umhlaza womlomo wesibeleko), i-ORR yayiyi-35.7%. Ngokukodwa, amanqaku ama-4 (28.6%) ayenempendulo engaphelelanga eqinisekisiweyo (PR), amanqaku ama-1 (7.1%) afumene impendulo epheleleyo (CR), kwaye amanqaku asi-8 (57.1%) ayenesifo esizinzileyo (SD) njengempendulo yabo engcono. Inqaku elinye lalinokuqhubela phambili kwesifo okungaqinisekiswanga (PD). Okuphawulekayo kukuba, phakathi kwezigulane ezili-11/14 ezinomhlaza womlomo wesibeleko, i-ORR yayiyi-45.5% (5/11) kunye namanqaku ama-4 (36.4%) afumana i-PR kunye nenqaku eli-1 (9.1%) afumana i-CR. Ulawulo lwesifo lubonwe kwi-10/11 pts (90.9%), kwaye i-PFS ephakathi yayiyiinyanga ezi-4.2 kweli qela. Isigulana se-CR salandelwa ixesha elide kwaye ubude be-CR kunye ne-PFS (eqikelelwa yiKaplan-Meier) yayiziiveki ezingama-24 kunye neeveki ezingama-36, ngokulandelelana. Emva kokufakwa kwe-GT101, iiseli ze-T zanda ngamandla egazini elingaphandle kwazo zonke izigulane ezine-Tmax ephakathi yeentsuku eziyi-6.83 kwaye umyinge weentsuku eziyi-15.9.

Izigqibo: Kwisifundo se-GT101 Phase 1, akukho zi-SAEs kunye ne-DLT ezinxulumene nonyango ezibonwe. Kwizigulane ezinee-tumor eziphucukileyo okanye eziguquliweyo ezinyangiweyo, i-GT101 ibonise iprofayili yokhuseleko elawulekayo phantsi kwenkqubo yonyango lwe-lymphodepletion kunye ne-IL-2 ephezulu kunye neprofayili yeklinikhi efanelekileyo, ngakumbi kumhlaza wesibeleko, ene-ORR ekhuthazayo kunye nobude bempendulo eqhubekayo.

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.grit-bio.com/newsinfo/4620292.html

2. https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2548