C-CAR031 ni uburyo bwo kuvura bwa GPC3-targeting chimeric antigen T-Cell (CAR-T) bukoreshwa mu buryo bwa autologous, burimo kwigwa ku kuvura HCC. Bushingiye ku buryo bushya bwa GPC3-targeting CAR-T bwakozwe na AstraZeneca hakoreshejwe uburyo bwabo bwo kuvumbura intwaro bukoresha uburyo bwa dominant negative transforming growth factor-beta receptor II dominant negative (dnTGFβRII) kandi bukorwa na AbelZeta mu Bushinwa. C-CAR031 irimo gutegurwa mu Bushinwa hakurikijwe amasezerano y’ubufatanye hagati ya AbelZeta na AstraZeneca.
AbelZeta yatangaje amakuru y’ubuvuzi agaragaza imikorere y’ibanze yo kurwanya ikibyimba kuri C-CAR031, ubwoko bw’indwara ya autologous GPC3 CAR-T, ku barwayi bafite kanseri y’umwijima ikomeye, mu nama ngarukamwaka ya ASCO 2024.
Uburyo: Igerageza rya mbere mu bantu, rikozwe mu buryo bwa open label, rikoresha uburyo bwo kwihutisha titration hamwe n’igishushanyo cya i3 + 3. Abaganga ba HCC ba GPC3 + bananiwe ubuvuzi bwa ≥ 1 line systemic bahawe iv imwe ya C-CAR031 post standard lymphodepletion. Ingaruka z'ibanze ni umutekano no kwihanganira, izindi zirimo farumasikinetics n'ubushobozi bw'ibanze. Ingaruka mbi (AEs) zapimwe hakurikijwe CTCAE 5.0, naho cytokine release syndrome (CRS) / immune effector cell-associated neurotoxicity syndrome (ICANS) zapimwe hakurikijwe ibipimo bya ASTCT 2019. Igisubizo cy'intego cyapimwe n'umushakashatsi hakurikijwe RECIST 1.1.
Ibisubizo: Ku ya 5 Mutarama 2024, abantu 24 bose hamwe bahawe C-CAR031 infusion ku rugero rwa dose 4 (DLs). Abantu bose bari bafite BCLC stage C HCC, 83.3% (20/24) bari bafite metastasis ya extrahepatic. Umubare w’imirongo yabanje yo kuvurwa wari 3.5 (kuva kuri 1 kugeza kuri 6), 23 (95.8%) bahawe ICI (immunite checkpoint inhibitors) na TKI (tyrosine kinase inhibitors). Abantu bose bapimwe ku mutekano wabo. Nta burozi bugabanya dose kandi ICANS yagaragaye. CRS yagaragaye mu byiciro 22 (91.7%) gusa hamwe na CRS 1 (4.2%) (G) 3 gusa. Indwara za ≥G3 AE zikunze kugaragara cyane ni lymphocytopenia (100%), neutropenia (70.8%), thrombocytopenia (37.5%) n'ubwiyongere bwa transaminase (16.7%). Igice kimwe (4.2%) cyari gifite G4 myelosuppression na pt 1 (4.2%) cyari gifite G3 interstitial pneumonitis kuri DL4 yatewe na G3 CRS. Indwara zose za AE zasubiwemo. Inshuro 22 zapimwe kugira ngo harebwe niba zigira ingaruka nziza. Kugabanuka kwa kanseri byagaragaye kuri 90.9% by'indwara, atari mu ndwara zo mu mwijima gusa ahubwo no mu ndwara zikomoka ku mwijima hamwe n'igabanuka ry'impuzandengo rya 44.0% (urugero, 3.4%-94.4%). Igipimo cyo kurwanya indwara cyari 90.9% naho igipimo cyo gusubiza neza (ORR) cyari 50.0% ku ndwara zose za DL. Muri DL4, ORR yari 57.1%.
Umwanzuro: Ubushakashatsi bwagaragaje ko umutekano ugenzurwa neza kandi bugatera inkunga imikorere ya C-CAR031 mu kurwanya ikibyimba mu barwayi ba HCC bavuwe cyane.
Tony (Bizuo) Liu, Perezida akaba n'Umuyobozi Mukuru wa AbelZeta yagize ati: “Duterwa inkunga n'ibisubizo bya mbere bya C-CAR031 ku barwayi ba kanseri y'umwijima (HCC) yateye imbere. Amakuru yatanzwe uyu munsi atanga igihamya gifatika cy'igitekerezo gishobora gusobanura uburyo bwo kuvura HCC n'izindi kanseri zikomeye zigaragaza GPC3.”
Umushakashatsi Mukuru (PI) w’ubushakashatsi, Porofeseri Tingbo Liang wo mu Bitaro bya Mbere bifitanye isano bya Kaminuza ya Zhejiang, yagize ati “C-CAR031 yagaragaje umutekano mwiza kandi ikora neza ku barwayi ba kanseri y’umwijima iri mu cyiciro cya nyuma, akenshi bafite uburyo buke bwo kuvura. Kuba ikibyimba cyaragabanutse mu barwayi benshi/banini (91.3%) byerekana ko C-CAR031 ifite ubushobozi bwo kuzana agaciro mu buvuzi no gutanga icyizere kuri abo barwayi.”
Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.
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Igihe cyo kohereza: Ukuboza 31-2024