C-CAR031 magani ne mai ɗauke da sinadarin antigen na GPC3 mai sarrafa kansa, wanda aka yi nazari a kansa don maganin HCC. Ya dogara ne akan wani sabon nau'in CAR-T mai sarrafa kansa na GPC3 wanda AstraZeneca ta tsara ta amfani da dandamalin gano kayan yaƙi na musamman mai canza yanayin girma-beta receptor II dominant negative (dnTGFβRII) kuma AbelZeta ne ke ƙera shi a China. Ana ƙera C-CAR031 a China ƙarƙashin yarjejeniyar haɗin gwiwa tsakanin AbelZeta da AstraZeneca.
AbelZeta ta sanar da bayanan asibiti da ke nuna aikin farko na hana ƙari ga C-CAR031, wani nau'in GPC3 CAR-T mai sulke, a cikin marasa lafiya da ke fama da cutar kansar hanta mai ci gaba, a taron shekara-shekara na ASCO 2024.
Hanyoyi: Gwajin farko a cikin ɗan adam, wanda aka yi wa lakabin buɗewa, yana amfani da ingantaccen titration tare da ƙirar i3+3. GPC3+ masu ci gaba na HCC waɗanda suka gaza maganin tsarin ≥ 1 sun sami jiko ɗaya na iv na C-CAR031 bayan an yi amfani da lymphostasis na yau da kullun. Babban maƙasudin ƙarshen sune aminci da jurewa, wasu sun haɗa da pharmacokinetics da ingancin farko. An kimanta abubuwan da suka faru marasa kyau (AEs) ta hanyar CTCAE 5.0, kuma an tantance cutar cytokine release syndrome (CRS) / immunoeffector neurotoxicity syndrome (ICANS) bisa ga ka'idojin ASTCT 2019. Mai bincike ya tantance martanin manufa ta hanyar RECIST 1.1.
Sakamako: Ya zuwa ranar 5 ga Janairu, 2024, jimillar maki 24 sun sami jiko na C-CAR031 a matakan allurai 4 (DLs). Duk maki suna da matakin BCLC C HCC, 83.3% (20/24) suna da metastasis na waje na hanta. Matsakaicin adadin layukan magani na baya shine 3.5 (tsakanin 1-6), maki 23 (95.8%) da aka karɓi ICIs (masu hana garkuwar jiki) da TKIs (masu hana tyrosine kinase). An kimanta duk maki don aminci. Babu guba mai iyakance allurai kuma an lura da ICANS. An lura da CRS a maki 22 (91.7%) tare da maki 1 (4.2%) na matakin (G) 3 CRS. Mafi yawan ≥G3 AEs sune lymphocytopenia (100%), neutropenia (70.8%), thrombocytopenia (37.5%) da haɓakar transaminase (16.7%). Mutum ɗaya (4.2%) yana da G4 myelosuppression kuma 1 pt (4.2%) yana da G3 interstitial pneumonia a DL4 wanda G3 CRS ya haifar. Duk AEs an iya mayar da su baya. An kimanta maki 22 don inganci. An lura da raguwar ƙari a cikin maki 90.9%, ba kawai a cikin raunukan ciki ba har ma da waɗanda ke waje da hanta tare da matsakaicin raguwar kashi 44.0% (kewayon, 3.4%-94.4%). Yawan rage cutar shine 90.9% kuma ƙimar amsawar manufa (ORR) shine 50.0% ga maki na duk DLs. A cikin DL4, ORR shine 57.1%.
Kammalawa: Binciken ya nuna ingantaccen tsarin aminci da kuma ƙarfafa aikin hana ƙari na C-CAR031 a cikin marasa lafiya da suka kamu da cutar HCC da aka yi wa magani sosai.
"Mun sami kwarin gwiwa daga sakamakon farko na asibiti na C-CAR031 a cikin marasa lafiya da suka kamu da cutar kansar hanta (HCC)," in ji Tony (Bizuo) Liu, Shugaba kuma Babban Jami'in Gudanarwa na AbelZeta. "Bayanan farko da aka gabatar a yau suna ba da hujja mai ƙarfi don sake fasalta yanayin magani a cikin HCC da sauran ciwon daji masu ƙarfi na GPC3."
Babban Mai Bincike (PI) na binciken, Farfesa Tingbo Liang daga Asibitin Farko da ke Jami'ar Zhejiang, ya ce "C-CAR031 ya nuna kyakkyawan yanayin tsaro da kuma ingantaccen tasiri ga marasa lafiya da ke fama da cutar kansar hanta ta ƙarshen lokaci, waɗanda galibi suna da ƙarancin zaɓuɓɓukan magani da ake da su. Ragewar ciwon daji da aka lura a cikin mafi yawan marasa lafiya (91.3%) ya nuna cewa C-CAR031 yana da yuwuwar kawo ƙimar asibiti da kuma bayar da bege ga waɗannan marasa lafiya."
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Lokacin Saƙo: Disamba-31-2024