C-CAR031, ib qho GPC3-specific TGFβRIIDN armored autologous CAR-T

C-CAR031 yog ib qho kev kho mob autologous, armored GPC3-targeting chimeric antigen receptor T-Cell (CAR-T), uas tab tom kawm txog kev kho mob HCC. Nws yog raws li ib qho tshiab GPC3-targeting CAR-T tsim los ntawm AstraZeneca siv lawv cov dominant negative transforming growth factor-beta receptor II dominant negative (dnTGFβRII) armoring discovery platform thiab yog tsim los ntawm AbelZeta hauv Suav teb. C-CAR031 tab tom raug tsim tawm hauv Suav teb raws li kev pom zoo sib koom ua ke ntawm AbelZeta thiab AstraZeneca.

AbelZeta tshaj tawm cov ntaub ntawv kho mob uas qhia txog kev ua haujlwm tiv thaiv qog nqaij hlav rau C-CAR031, ib qho armored autologous GPC3 CAR-T, rau cov neeg mob uas muaj mob qog nqaij hlav siab heev, ntawm ASCO Lub Rooj Sib Tham Txhua Xyoo 2024

Cov Txheej Txheem: Qhov kev sim tshuaj thawj zaug hauv tib neeg, qhib daim ntawv lo rau kev nce koob tshuaj siv kev tsim qauv titration ntxiv rau i3 + 3. GPC3 + ​​cov neeg mob HCC siab heev uas tsis ua tiav ≥ 1 kab kev kho mob tau txais ib qho iv infusion ntawm C-CAR031 tom qab tus qauv lymphodepletion. Cov ntsiab lus tseem ceeb yog kev nyab xeeb thiab kev kam rau siab, lwm yam suav nrog pharmacokinetics thiab kev ua tau zoo ua ntej. Cov xwm txheej tsis zoo (AEs) tau raug ntsuas los ntawm CTCAE 5.0, thiab cytokine release syndrome (CRS) / immune effector cell-associated neurotoxicity syndrome (ICANS) tau raug soj ntsuam raws li ASTCT 2019 cov qauv. Cov lus teb tau raug soj ntsuam los ntawm tus kws tshawb nrhiav raws li RECIST 1.1.

Cov Txiaj Ntsig: Txij li Lub Ib Hlis 5, 2024, tag nrho ntawm 24 pts tau txais C-CAR031 infusion ntawm 4 koob tshuaj (DLs). Tag nrho cov pts muaj BCLC theem C HCC, 83.3% (20/24) muaj extrahepatic metastasis. Tus lej nruab nrab ntawm cov kab kev kho mob yav dhau los yog 3.5 (ntau yam 1-6), 23 (95.8%) pts tau txais ICIs (immune checkpoint inhibitors) thiab TKIs (tyrosine kinase inhibitors). Tag nrho cov pts tau soj ntsuam rau kev nyab xeeb. Tsis muaj tshuaj lom uas txwv tsis pub noj tshuaj thiab ICANS tau pom. CRS tau pom hauv 22 (91.7%) pts nrog tsuas yog 1 (4.2%) qib (G) 3 CRS. Cov ≥G3 AEs feem ntau yog lymphocytopenia (100%), neutropenia (70.8%), thrombocytopenia (37.5%) thiab transaminase elevation (16.7%). Ib qho pt (4.2%) muaj G4 myelosuppression thiab 1 pt (4.2%) muaj G3 interstitial pneumonitis ntawm DL4 los ntawm G3 CRS. Tag nrho cov AEs yog rov qab tau. 22 pts tau soj ntsuam rau qhov ua tau zoo. Kev txo qis ntawm cov qog tau pom hauv 90.9% pts, tsis yog tsuas yog hauv cov qhov txhab intrahepatic tab sis kuj tseem muaj extrahepatic nrog qhov nruab nrab txo qis ntawm 44.0% (ntau yam, 3.4% -94.4%). Tus nqi tswj kab mob yog 90.9% thiab tus nqi teb lub hom phiaj (ORR) yog 50.0% rau pts ntawm txhua DLs. Hauv DL4, ORR yog 57.1%.

Xaus Lus: Txoj kev tshawb fawb no tau qhia txog kev nyab xeeb uas tswj tau thiab txhawb kom muaj kev ua haujlwm tiv thaiv qog ntawm C-CAR031 hauv cov neeg mob HCC uas tau kho mob hnyav.

"Peb zoo siab heev rau cov txiaj ntsig kho mob thawj zaug ntawm C-CAR031 hauv cov neeg mob hepatocellular carcinoma (HCC) uas mob hnyav heev," Tony (Bizuo) Liu, Tus Thawj Coj thiab CEO ntawm AbelZeta hais. "Cov ntaub ntawv thaum ntxov uas tau nthuav tawm hnub no muab cov pov thawj ntawm lub tswv yim zoo los txhais cov qauv kho mob hauv HCC thiab lwm yam qog nqaij hlav GPC3."

Tus Kws Tshawb Fawb Tseem Ceeb (PI) ntawm txoj kev tshawb fawb no, Xibfwb Tingbo Liang los ntawm Tsev Kho Mob First Affiliated ntawm Zhejiang University, tau hais tias "C-CAR031 tau qhia txog kev nyab xeeb zoo thiab kev ua haujlwm zoo rau cov neeg mob qog nqaij hlav hepatocellular theem kawg, uas feem ntau muaj cov kev xaiv kho mob tsawg. Qhov pom tau tias qog nqaij hlav me me hauv feem coob (91.3%) ntawm cov neeg mob qhia tias C-CAR031 muaj peev xwm coj tus nqi kho mob thiab muab kev cia siab rau cov neeg mob no."

Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.

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Cov ntaub ntawv siv los ua piv txwv

1.AbelZeta tshaj tawm cov ntaub ntawv kho mob uas qhia txog kev ua haujlwm tiv thaiv qog nqaij hlav rau C-CAR031, ib qho armored autologous GPC3 CAR-T, rau cov neeg mob uas muaj mob qog nqaij hlav siab heev, ntawm ASCO Lub Rooj Sib Tham Txhua Xyoo 2024 - AbelZeta Pharma

2.Kev tshawb fawb theem I ntawm C-CAR031, ib qho GPC3-specific TGFβRIIDN armored autologous CAR-T, rau cov neeg mob uas muaj mob qog nqaij hlav siab (HCC). | Journal of Clinical Oncology (ascopubs.org)