I-Glioblastoma Multiforme (GBM) ingenye yezinhlobo zomdlavuza ezibulala kakhulu, futhi cishe zonke iziguli ziphinde zibhekane nokwanda kwesifo ngokwezinga lamanje lokunakekelwa kwe-GBM esanda kutholakala. I-GBM ephindaphindayo (rGBM) ibonisa ukusinda okuphakathi okungaphansi kwezinyanga ezingu-8 ngezinketho zokwelapha ezilinganiselwe.
I-TX103 umuthi wokwelapha amaseli e-CAR-T ohlose i-B7-H3, owakhiwe ngokuzimela futhi wagunyazwa ngamalungelo obunikazi aseShayina nawamazwe ngamazwe. Imiphumela yokuqala yezokwelapha ye-TX103 yokwelashwa kwama-gliomas aphindaphindayo yethulwe eMhlanganweni Waminyaka Yonke we-American Society of Clinical Oncology (ASCO) ngo-2024.(I-1965)I-NCT05241392）.
Izindlela: Lolu ucwaningo oluvulekile, olungangengalo eyodwa, "lokwenyuka komthamo ongu-3+3" kanye nolwemithamo eminingi. Inhloso eyinhloko kwakuwukuhlola ukuphepha kanye nomthamo obekezelelwe kakhulu. Izinhloso zesibili zazihlanganisa imiphumela yokusinda, izimpendulo zesimila, izimpendulo ze-immunological, kanye nemingcele ye-pharmacokinetic. Iziguli ezineminyaka engu-18 kuya ku-75 zabhaliswa ngokuphindeka okuqinisekisiwe ngokuskena isithombe kanye nokubonakaliswa kwe-B7-H3 >= 30% ngokuhlaziywa kwe-immunohistochemistry. I-TX103 yanikezwa iziguli ngaphakathi kwe-cavity kanye/noma ngaphakathi kwe-ventricular ngokusebenzisa i-Ommaya reservoir. I-TX103 yanikezwa iziguli njalo ngeviki ezimbili umjikelezo ngamunye emazingeni omthamo 1, 2, kanye no-3 (amaseli ayizigidi ezingu-20, 60, 150, ngokulandelana), ngemijikelezo emine njengenkambo eyodwa.
Imiphumela: Phakathi kukaMashi 2022 noJanuwari 2024, iziguli ezingu-13 zithole okungenani ukumnika okukodwa kwe-TX103 ngaphakathi kwekhanda, kanye neziguli ezingu-3, 4, kanye nezingu-6 emazingeni omthamo 1, 2, kanye no-3, ngokulandelana. Inani elimaphakathi lemijikelezo yokumnika lalingu-4 (Okungenani, Okuphezulu 1,9). Zonke iziguli zifakiwe ekuhlaziyweni kokuphepha, okuveza ukuthi akukho ubuthi obukhawulela umthamo noma ukufa okuhlobene nokwelashwa kwe-CAR-T. Zonke iziguli zithole okungenani isenzakalo esisodwa esibi (AE), kanti ama-AE ahlobene nokwelashwa (TRAEs) afaka phakathi i-cytokine release syndrome, ukwanda kwengcindezi yangaphakathi kwekhanda (ICP), ikhanda elibuhlungu, isifo sokuwa, ukwehla kwezinga lokuqwasha, ukuhlanza, kanye ne-pyrexia. Iningi lama-TRAE laliyibanga 1-2, kuyilapho ama-TRAE amathathu ebanga 3 abonwe: icala elilodwa lokwanda kwe-ICP ezingeni lomthamo 2, icala elilodwa lokuwa, kanye nelinye icala lokwehla kwezinga lokuqwasha ezingeni lomthamo 3. Kusukela ngoJanuwari 2024, iziguli eziyisithupha ezivela emazingeni omthamo 1 kanye no-2 zazifanelekela ukuhlolwa kokusinda kwezinyanga ezingu-12; izinga lokusinda okuphelele kwezinyanga eziyi-12 (i-OS) lalingu-83.3% (95% CI: 58.3%~100%), kanti i-OS ephakathi yayingama-20.3 izinyanga (95% CI: 20.3~ayifinyeleleki). Ababili kweziguli ezintathu ezivela ezingeni lomthamo 2 bathole izimpendulo ezingaphelele neziphelele, ngokulandelana. Ngemva kokuphathwa kwe-CAR-T, ukwanda okukhulu kwama-cytokine, okuhlanganisa i-IL-6 kanye ne-IFN-γ, kanye nezinombolo zamakhophi aphezulu ze-gene ye-CAR kwabonwa ku-cerebrospinal fluid, kuyilapho ukuphakama okuncane kuphela kwaphawulwa egazini elingaphandle.
Iziphetho: Kulolu cwaningo, ukwelapha i-rGBM nge-TX103 kubhekwa njengokuphephile futhi okubekezelelwayo. Le miphumela yesikhashana isekela ucwaningo olwengeziwe olusebenzisa i-TX103 ukuthuthukisa imiphumela yokusinda ezigulini ezine-rGBM.
Njengamanje, kunezinye izivivinyo eziningi ze-CAR-T eShayina, futhi zifuna iziguli. Ukuze uthole ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
Email：myimmnet@163.com
Isikhathi sokuthunyelwe: Disemba-09-2024