C-CAR031 bụ ọgwụgwọ GPC3 nke na-elekwasị anya na chimeric antigen receptor T-Cell (CAR-T), nke a na-amụ maka ọgwụgwọ HCC. Ọ dabere na CAR-T ọhụrụ nke GPC3-targeting nke AstraZeneca mepụtara site na iji ikpo okwu nchọpụta agha ha nke na-agbanwe agbanwe-beta receptor II dominant negative (dnTGFβRII) ma AbelZeta na China mepụtara ya. A na-emepụta C-CAR031 na China n'okpuru nkwekọrịta mmepe n'etiti AbelZeta na AstraZeneca.
AbelZeta kwupụtara data ahụike na-egosi ọrụ mbụ nke mgbochi etuto ahụ maka C-CAR031, GPC3 CAR-T nke nwere ngwa agha, na ndị ọrịa nwere kansa hepatocellular dị elu, na Nzukọ Kwa Afọ nke ASCO 2024.
Usoro: Nnwale nke mbụ n'ime mmadụ, nke mepere emepe, na-eji usoro titration ngwa ngwa yana nhazi i3+3. Ndị GPC3+ dị elu HCC pts ndị dara ≥ 1 line systemic systemic natara otu iv infusion nke C-CAR031 mgbe ọkwa lymphodepletion gasịrị. Isi ihe ndị bụ isi bụ nchekwa na ndidi, ndị ọzọ gụnyere pharmacokinetics na arụmọrụ mbụ. E nyere akara ihe ọjọọ (AEs) site na CTCAE 5.0, e wee nyochaa cytokine release syndrome (CRS) / immunoeffector cell-associated neurotoxicity syndrome (ICANS) dịka ụkpụrụ ASTCT 2019 si dị. Onye nyocha nyochara azịza ebumnuche site na RECIST 1.1.
Nsonaazụ: Dịka ọ dị na Jenụwarị 5, 2024, ngụkọta nke mmadụ 24 natara ọgwụ C-CAR031 na ọkwa dose 4 (DLs). Ndị niile nwere BCLC stage C HCC, 83.3% (20/24) nwere metastasis extrahepatic. Ọnụọgụ etiti nke usoro ọgwụgwọ gara aga bụ 3.5 (oke 1-6), 23 (95.8%) ndị natara ICI (ihe mgbochi mgbochi ahụ ji alụso ọrịa ọgụ) na TKIs (ihe mgbochi tyrosine kinase). A na-enyocha ule niile maka nchekwa. Enweghị nsí na-egbochi dose na ICANS. A hụrụ CRS na 22 (91.7%) na naanị 1 (4.2%) ọkwa (G) 3 CRS. Ndị kacha ≥G3 AE bụ lymphocytopenia (100%), neutropenia (70.8%), thrombocytopenia (37.5%) na mmụba transaminase (16.7%). Otu pt (4.2%) nwere G4 myelosuppression na 1 pt (4.2%) nwere G3 interstitial pneumonitis na DL4 nke G3 CRS kpatara. AE niile nwere ike ịgbanwe. A tụlere 22 pts maka irè. A hụrụ mbelata etuto ahụ na 90.9% pts, ọ bụghị naanị na ọnya intrahepatic kamakwa na ndị na-anaghị ewepụ hepatic na mbelata etiti nke 44.0% (oke, 3.4%-94.4%). Ọnụego njikwa ọrịa ahụ bụ 90.9% yana ọnụego nzaghachi ebumnuche (ORR) bụ 50.0% maka pts nke DL niile. Na DL4, ORR bụ 57.1%.
Mmechi: Ọmụmụ ihe ahụ gosiri nchekwa dị mma nke ọma ma na-agba ume ka C-CAR031 na-alụso ọrịa kansa ọgụ n'ime ndị ọrịa HCC dị elu a na-agwọ nke ọma.
"Nsonaazụ mbụ nke C-CAR031 n'ime ndị ọrịa hepatocellular carcinoma (HCC) dị elu na-agba anyị ume," ka Tony (Bizuo) Liu, Onyeisi oche na CEO nke AbelZeta kwuru. "Data mbụ ewepụtara taa na-enye ihe akaebe siri ike nke echiche iji nwee ike ịkọwaghachi usoro ọgwụgwọ na HCC na etuto siri ike ndị ọzọ na-egosipụta GPC3."
Onyeisi Nnyocha (PI) nke ọmụmụ ihe a, Prọfesọ Tingbo Liang nke Ụlọ Ọgwụ Mbụ nke Mahadum Zhejiang, kwuru na "C-CAR031 gosipụtara ezigbo nchekwa yana irè dị mma n'ahụ ndị ọrịa kansa imeju na-arịa ọrịa n'oge ikpeazụ, bụ́ ndị na-enwekarị ọnụọgụ ọgwụgwọ dị ole na ole. Mbelata etuto ahụ a hụrụ n'ọtụtụ/ọtụtụ (91.3%) nke ndị ọrịa na-egosi na C-CAR031 nwere ike iweta uru ahụike ma nye ndị ọrịa a olileanya."
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
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Oge ozi: Disemba-31-2024