He lāʻau lapaʻau autologous, armored GPC3-targeting chimeric antigen receptor T-Cell (CAR-T) ʻo C-CAR031, e aʻo ʻia nei no ka mālama ʻana i ka HCC. Hoʻokumu ʻia ia ma luna o kahi CAR-T GPC3-targeting hou i hoʻolālā ʻia e AstraZeneca me ka hoʻohana ʻana i kā lākou dominant negative transforming growth factor-beta receptor II dominant negative (dnTGFβRII) armoring discovery platform a ua hana ʻia e AbelZeta ma Kina. Ke hoʻomohala ʻia nei ʻo C-CAR031 ma Kina ma lalo o kahi ʻaelike hoʻomohala like ma waena o AbelZeta lāua ʻo AstraZeneca.
Hoʻolaha ʻo AbelZeta i ka ʻikepili lapaʻau e hōʻike ana i ka hana anti-tumor mua no C-CAR031, kahi GPC3 CAR-T autologous i hoʻopaʻa ʻia, i nā poʻe maʻi me ka carcinoma hepatocellular holomua, ma ka Hālāwai Makahiki ASCO 2024
Nā Hana: ʻO ka hoʻokolohua hoʻonui nui mua loa i ke kanaka, hāmama ka lepili, e hoʻohana ana i kahi hoʻolālā titration wikiwiki me i3+3. ʻO nā poʻe HCC holomua GPC3+ i hāʻule i nā lāʻau lapaʻau ʻōnaehana ≥ 1 laina i loaʻa i hoʻokahi infusion iv o C-CAR031 ma hope o ka lymphodepletion maʻamau. ʻO nā hopena mua ka palekana a me ka hoʻomanawanui, ʻo nā mea ʻē aʻe e komo pū me ka pharmacokinetics a me ka pono mua. Ua helu ʻia nā hanana ʻino (AEs) e CTCAE 5.0, a ua loiloi ʻia ka cytokine release syndrome (CRS) / immune effector cell-associated neurotoxicity syndrome (ICANS) e like me nā pae hoʻohālikelike ASTCT 2019. Ua loiloi ʻia ka pane pahuhopu e ka mea noiʻi e like me RECIST 1.1.
Nā Hualoaʻa: Ma Ianuali 5, 2024, he 24 mau pts i loaʻa i ka hoʻokomo ʻana o C-CAR031 ma 4 mau pae mahele (DLs). Loaʻa i nā pts āpau ke kahua BCLC C HCC, 83.3% (20/24) i loaʻa ka metastasis extrahepatic. ʻO ka helu waena o nā laina mua o ka lāʻau lapaʻau he 3.5 (pae 1-6), 23 (95.8%) pts i loaʻa i nā ICI (nā mea pale i ka nānā ʻana o ka pale) a me nā TKI (nā mea pale tyrosine kinase). Hiki ke loiloi ʻia nā pts āpau no ka palekana. ʻAʻohe ʻawaʻawa palena mahele a ua ʻike ʻia nā ICANS. Ua ʻike ʻia ʻo CRS ma 22 (91.7%) pts me 1 wale nō (4.2%) papa (G) 3 CRS. ʻO nā ≥G3 AE maʻamau loa he lymphocytopenia (100%), neutropenia (70.8%), thrombocytopenia (37.5%) a me ka hoʻokiʻekiʻe ʻana o ka transaminase (16.7%). Hoʻokahi pt (4.2%) i loaʻa i ka G4 myelosuppression a me 1 pt (4.2%) i loaʻa i ka G3 interstitial pneumonitis ma DL4 i hoʻokumu ʻia e G3 CRS. Ua hoʻohuli ʻia nā AE āpau. Hiki ke loiloi ʻia he 22 pts no ka pono. Ua ʻike ʻia ka hōʻemi ʻana o ka tumor ma 90.9% pts, ʻaʻole wale ma nā ʻeha intrahepatic akā ʻo nā mea extrahepatic me ka hōʻemi waena o 44.0% (pae, 3.4%-94.4%). ʻO ka helu kaohi maʻi he 90.9% a ʻo ka helu pane pahuhopu (ORR) he 50.0% no nā pts o nā DL āpau. Ma DL4, ʻo ka ORR he 57.1%.
Nā hopena: Ua hōʻike ke aʻo ʻana i kahi ʻano palekana e hiki ke hoʻokele ʻia a me ka hoʻoikaika ʻana i ka hana anti-tumor o C-CAR031 i nā poʻe maʻi HCC holomua i mālama nui ʻia.
"Ua hoʻoikaika ʻia mākou e nā hopena lapaʻau mua o C-CAR031 i nā poʻe maʻi hepatocellular carcinoma (HCC) holomua," wahi a Tony (Bizuo) Liu, Luna Hoʻomalu a me CEO o AbelZeta. "Hāʻawi nā ʻikepili mua i hōʻike ʻia i kēia lā i kahi hōʻoia hōʻoia o ka manaʻo e hiki ai ke wehewehe hou i nā paradigms therapeutic i loko o HCC a me nā puʻupuʻu paʻa ʻē aʻe e hōʻike ana i ka GPC3."
Ua ʻōlelo ʻo Polofesa Tingbo Liang, ka mea noiʻi nui o ke aʻo ʻana, mai ka Halemai Pili Mua o ke Kulanui ʻo Zhejiang, "Ua hōʻike ʻo C-CAR031 i kahi ʻano palekana maikaʻi a me ka pono e hoʻohiki ana i nā poʻe maʻi carcinoma hepatocellular pae hope loa, nona ka helu palena o nā koho lapaʻau i loaʻa. ʻO ka emi ʻana o ka puʻupuʻu i ʻike ʻia ma ka hapa nui/nui loa (91.3%) o nā maʻi e hōʻike ana he hiki iā C-CAR031 ke lawe mai i ka waiwai lapaʻau a hāʻawi i ka manaʻolana i kēia mau maʻi."
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
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Ka manawa hoʻouna: Dec-31-2024