Malunga ne-C-CAR031

I-C-CAR031 lunyango lwe-autologous, olujoliswe kwi-chimeric antigen receptor T-Cell (CAR-T) olujoliswe kwi-GPC3, olufundwayo kunyango lwe-HCC.

Inkqubela phambili yophando lwe-C-CAR031 kwi-hepatocellular carcinoma (HCC) yavezwa ngomlomo kwintlanganiso yonyaka ye-American Society of Clinical Oncology (ASCO) eyayibanjelwe eChicago ngo-2024.

Iindlela: Uvavanyo lokuqala oluvela ebantwini, olusebenzisa i-open-label dose-escalation lusebenzisa i-titration ekhawulezileyo kunye noyilo lwe-i3+3. Ii-GPC3+ advanced HCC pts ezingaphumelelanga kunyango oluyi-≥ 1 line systemic zifumene i-iv infusion enye ye-C-CAR031 post standard lymphodepletion. Isiphelo esiphambili kukhuseleko kunye nokunyamezeleka, ezinye ziquka i-pharmacokinetics kunye nokusebenza kwangaphambili. Iziganeko ezimbi (ii-AE) zibekwe kwinqanaba le-CTCAE 5.0, kunye ne-cytokine release syndrome (CRS) / immune effector cell-associated neurotoxicity syndrome (ICANS) zivavanywe ngokweekhrayitheriya ze-ASTCT 2019. Impendulo ejolise ekuhlolweni ihlolwe ngumphandi ngokwe-RECIST 1.1.

Iziphumo: Ukusukela nge-5 kaJanuwari 2024, inani elipheleleyo lama-pts angama-24 afumene i-C-CAR031 infusion kumanqanaba eedosi ezi-4 (ii-DL). Zonke ii-pts zazine-BCLC stage C HCC, i-83.3% (20/24) yayine-metastasis engaphandle kwesibindi. Inani eliphakathi lemigca yangaphambili yonyango yayiyi-3.5 (uluhlu 1-6), ama-pts angama-23 (95.8%) afumene ii-ICI (i-immune checkpoint inhibitors) kunye nee-TKI (i-tyrosine kinase inhibitors). Zonke ii-pts zazivavanywa ukhuseleko. Akukho tyhefu ithintela idosi kwaye i-ICANS yabonwa. I-CRS yabonwa kuma-pts angama-22 (91.7%) kuphela nge-1 (4.2%) grade (G) 3 CRS. Ezona ≥G3 AE zixhaphakileyo yayiyi-lymphocytopenia (100%), i-neutropenia (70.8%), i-thrombocytopenia (37.5%) kunye nokuphakama kwe-transaminase (16.7%). I-pt enye (4.2%) yayine-G4 myelosuppression kunye ne-pt e-1 (4.2%) yayine-G3 interstitial pneumonitis kwi-DL4 ebangelwe yi-G3 CRS. Zonke ii-AE zazinokuguqulwa. Ii-pts ezingama-22 zavavanywa ukuba ziyasebenza na. Ukuncipha kwe-tumor kwabonwa kwi-90.9% pts, kungekuphela nje kwizilonda ze-intrahepatic kodwa nakwi-extrahepatic kunye nokuncipha okuphakathi kwe-44.0% (uluhlu, 3.4%-94.4%). Izinga lokulawula isifo yayiyi-90.9% kwaye izinga lokuphendula elijolise ngqo (ORR) yayiyi-50.0% kwii-pts zazo zonke ii-DL. Kwi-DL4, i-ORR yayiyi-57.1%.

Izigqibo: Olu phononongo lubonise iprofayili yokhuseleko elawulekayo kwaye lukhuthaza umsebenzi we-C-CAR031 wokulwa nethumba kwizigulana ze-HCC ezinyangwe kakhulu.

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.prnewswire.com/news-releases/abelzeta-announces-clinical-data-showing-preliminary-anti-tumor-activity-for-c-car031-an-armored-autologous-gpc3-car-t-in-patients-with-advanced-hepatocellular-carcinoma-at-asco-annual-meeting-2024-302162941.html

2.https://www.abelzeta.com/abelzeta-announces-abstract-for-c-car031-accepted-for-presentation-at-the-2024-american-society-of-clinical-oncology-asco-annual-meeting/

3.https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.4019

4.I-ASCO-2024-IR-Presentation.pdf (astrazeneca.com)