Mayelana ne-C-CAR031

I-C-CAR031 iyindlela yokwelapha ye-T-Cell (CAR-T) eqondiswe yi-chimeric antigen receptor (GPC3) ehlosiwe, efundelwa ukwelashwa kwe-HCC.

Inqubekela phambili yocwaningo lwe-C-CAR031 ku-hepatocellular carcinoma (HCC) yethulwe ngomlomo emhlanganweni waminyaka yonke we-American Society of Clinical Oncology (ASCO) owawuseChicago ngo-2024.

Izindlela: Isivivinyo sokuqala esikumuntu, esivulelekile sokwanda komthamo sisebenzisa i-titration esheshisiwe kanye nomklamo we-i3+3. Ama-pts e-HCC athuthukile e-GPC3+ ahlulekile ukwelashwa okujwayelekile komugqa ongu-≥ 1 athole ukumnika okukodwa kwe-iv kwe-C-CAR031 post standard lymphodepletion. Ama-endpoint ayinhloko ukuphepha nokubekezeleleka, amanye afaka phakathi i-pharmacokinetics kanye nokusebenza kahle kokuqala. Izehlakalo ezimbi (ama-AE) zilinganiswe yi-CTCAE 5.0, kanye ne-cytokine release syndrome (CRS) / immune effector cell-associated neurotoxicity syndrome (ICANS) zihlolwe ngokwezindlela ze-ASTCT 2019. Impendulo eqondile ihlolwe ngumphenyi ngokwe-RECIST 1.1.

Imiphumela: Kusukela ngomhlaka-5 Januwari 2024, inani lama-pts angu-24 lathola ukumnika kwe-C-CAR031 kumazinga omthamo angu-4 (ama-DL). Wonke ama-pts ayene-BCLC stage C HCC, ama-83.3% (20/24) ayene-metastasis yangaphandle kwesibindi. Inani elimaphakathi lemigqa yokwelashwa yangaphambili lalingu-3.5 (ububanzi 1-6), ama-pts angu-23 (95.8%) athola ama-ICI (izivimbeli zokuhlola amasosha omzimba) kanye nama-TKI (izivimbeli ze-tyrosine kinase). Wonke ama-pts ahlolwe ngokuphepha. Akukho ubuthi obukhawulela umthamo futhi ama-ICANS abonwe. I-CRS yabonwa kuma-pts angu-22 (91.7%) kuphela ane-1 (4.2%) grade (G) 3 CRS. Ama-≥G3 AE avame kakhulu kwakuyi-lymphocytopenia (100%), i-neutropenia (70.8%), i-thrombocytopenia (37.5%) kanye nokuphakama kwe-transaminase (16.7%). I-pt eyodwa (4.2%) yayine-G4 myelosuppression kanye ne-pt eyodwa (4.2%) yayine-G3 interstitial pneumonitis ku-DL4 ebangelwe yi-G3 CRS. Wonke ama-AE abuyiselwa emuva. Ama-pts angu-22 ahlolwe ukusebenza kahle. Ukuncipha kwezicubu kubonwe kuma-pts angu-90.9%, hhayi kuphela ezilondeni zesibindi kodwa nakwezingaphandle kwesibindi ngokuncipha okumaphakathi okungu-44.0% (ububanzi, 3.4%-94.4%). Izinga lokulawula isifo lalingu-90.9% kanti izinga lokuphendula eliqondile (ORR) lalingu-50.0% kuma-pts azo zonke i-DL. Ku-DL4, i-ORR yayingu-57.1%.

Iziphetho: Ucwaningo lubonise iphrofayili yokuphepha elawulekayo futhi lukhuthaza umsebenzi wokulwa nomdlavuza we-C-CAR031 ezigulini ze-HCC eziphathwe kabi kakhulu.

Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.

Inombolo yocingo: 4008803716

Email：myimmnet@163.com

Izinkomba

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)