E uiga i le C-CAR031

O le C-CAR031 o se togafitiga fa'apitoa e fa'atatau i le chimeric antigen receptor T-Cell (CAR-T), o lo'o su'esu'eina mo le togafitia o le HCC.

O le alualu i luma o suʻesuʻega o le C-CAR031 i le hepatocellular carcinoma (HCC) na tuʻuina atu i le fonotaga faʻaletausaga a le American Society of Clinical Oncology (ASCO) na faia i Chicago i le 2024.

Metotia: O le ulua'i su'ega i le tagata soifua, o le fa'ateleina o le fuala'au e tatala le igoa, e fa'aaogaina ai le mamanu fa'avavevaveina o le titration fa'atasi ai ma le i3+3. O tagata GPC3+ HCC maualuga na le manuia i togafitiga fa'apitoa e ≥ 1 laina na maua le tui e tasi o le C-CAR031 i le mae'a ai o le lymphodepletion masani. O fa'ai'uga autu o le saogalemu ma le mafai ona onosa'i, o isi e aofia ai le pharmacokinetics ma le aoga muamua. O mea leaga na tutupu (AEs) na fa'avasegaina e le CTCAE 5.0, ma le cytokine release syndrome (CRS) / immune effector cell-associated neurotoxicity syndrome (ICANS) na iloiloina e tusa ai ma ta'iala a le ASTCT 2019. O le tali fa'amoemoe na iloiloina e le tagata su'esu'e e tusa ai ma le RECIST 1.1.

Fa'ai'uga: E o'o atu i le aso 5 o Ianuari, 2024, e 24 tagata na maua le tui C-CAR031 i le 4 fua fa'atatau (DLs). O tagata uma na maua i le BCLC stage C HCC, 83.3% (20/24) na maua i le extrahepatic metastasis. O le averesi o le aofa'i o laina muamua o togafitiga e 3.5 (vaega 1-6), 23 (95.8%) tagata na maua ICIs (immune checkpoint inhibitors) ma TKIs (tyrosine kinase inhibitors). O tagata uma na mafai ona iloiloina mo le saogalemu. E leai se fa'atapula'aina o le oona ma na matauina le ICANS. Na matauina le CRS i le 22 (91.7%) tagata ma na'o le 1 (4.2%) vasega (G) 3 CRS. O le ≥G3 AEs e sili ona taatele o le lymphocytopenia (100%), neutropenia (70.8%), thrombocytopenia (37.5%) ma le transaminase elevation (16.7%). E tasi le pt (4.2%) na maua i le G4 myelosuppression ma le 1 pt (4.2%) na maua i le G3 interstitial pneumonitis i le DL4 na mafua mai i le G3 CRS. O AE uma na mafai ona toe fa'aleleia. E 22 pts na mafai ona iloiloina mo le aoga. Na matauina le fa'aitiitia o le tumo i le 90.9% pts, e le gata i le intrahepatic lesions ae fa'apea fo'i i extrahepatic ma le averesi o le fa'aitiitia o le 44.0% (laina, 3.4%-94.4%). O le fua faatatau o le puleaina o le fa'ama'i e 90.9% ma le fua faatatau o le tali atu (ORR) e 50.0% mo pts o DLs uma. I le DL4, o le ORR e 57.1%.

Fa'ai'uga: O le su'esu'ega na fa'aalia ai se tulaga saogalemu e mafai ona pulea ma fa'amalosia ai le malosi o le C-CAR031 e tete'e ai i le tumo i gasegase HCC ua matua'i togafitia.

I le taimi nei, o loʻo tele pea suʻega faafomaʻi o tekinolosi fou e teteʻe ai i le kanesa i Saina o loʻo sailia ai ni gasegase. Mo feutagaiga i vailaʻau ma tekinolosi fou, e mafai ona e faʻafesoʻotaʻi le Matagaluega Faʻavaomalo a le Falemaʻi Oncology a le Itumalo i Saute o Beijing.

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Fa'asinomaga

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