Ku saabsan C-CAR031

C-CAR031 waa daaweyn iskiis ah oo GPC3 ah oo gaashaaman oo ah receptor T-Cell (CAR-T) oo lagu daweynayo HCC.

Horumarka cilmi-baarista ee C-CAR031 ee kansarka beerka ku dhaca (HCC) ayaa si afka ah loogu soo bandhigay shirkii sanadlaha ahaa ee Ururka Caafimaadka ee Mareykanka (ASCO) oo lagu qabtay Chicago sanadkii 2024.

Hababka: Tijaabada qiyaasta kor u qaadista ee ugu horreysa ee aadanaha, calaamadda furan, waxay isticmaashaa titration degdeg ah oo lagu daray naqshad i3+3. GPC3+ pts oo horumarsan oo HCC ah oo ku guuldareystay daaweynta nidaamsan ee ≥ 1 xariiq ayaa helay hal iv oo ah C-CAR031 ka dib heerka lymphostasis-ka. Dhibcaha ugu horreeya waa badbaadada iyo dulqaadka, kuwa kale waxaa ka mid ah farmasokinetics iyo waxtarka hordhaca ah. Dhacdooyinka xunxun (AEs) waxaa lagu qiimeeyay CTCAE 5.0, iyo cudurka sii deynta cytokine (CRS) / cudurka neurotoxicity-ga ee la xiriira unugyada saamaynta difaaca jirka (ICANS) ayaa lagu qiimeeyay shuruudaha ASTCT 2019. Jawaabta ujeeddada waxaa qiimeeyay baaraha RECIST 1.1.

Natiijooyinka: Laga bilaabo Janaayo 5, 2024, wadarta 24 dhibcood ayaa la siiyay faleebo C-CAR031 ah oo leh 4 heer oo qiyaas ah (DLs). Dhammaan xaaladaha waxay lahaayeen heerka BCLC C HCC, 83.3% (20/24) waxay lahaayeen metastasis ka baxsan beerka. Tirada dhexdhexaadka ah ee khadadka daaweynta ee hore waxay ahayd 3.5 (inta u dhaxaysa 1-6), 23 (95.8%) dhibcood ayaa la siiyay ICIs (inhibitors-ka difaaca jirka) iyo TKIs (inhibitors-ka tyrosine kinase). Dhammaan xaaladaha waxaa lagu qiimeeyay badbaadada. Ma jirin sunta xaddidaysa qiyaasta, ICANS-na lama arag. CRS waxaa lagu arkay 22 (91.7%) dhibcood oo keliya iyadoo 1 (4.2%) darajo (G) 3 CRS ah. Kuwa ugu badan ee ≥G3 AEs waxay ahaayeen lymphocytopenia (100%), neutropenia (70.8%), thrombocytopenia (37.5%) iyo kor u kaca transaminase (16.7%). Hal dhibcood (4.2%) wuxuu lahaa G4 myelosuppression iyo 1 dhibcood (4.2%) wuxuu lahaa G3 interstitial pneumonia oo ku taal DL4 oo ay sababtay G3 CRS. Dhammaan AE-yadu way soo noqon karaan. 22 dhibcood ayaa lagu qiimeeyay waxtarkooda. Hoos u dhaca burooyinka waxaa lagu arkay 90.9% dhibcood, ma aha oo kaliya dhaawacyada gudaha beerka laakiin sidoo kale kuwa ka baxsan beerka iyadoo dhexdhexaad ah uu yahay 44.0% (kala duwanaanshaha, 3.4%-94.4%). Heerka xakamaynta cudurku wuxuu ahaa 90.9% heerka jawaab celinta ujeeddada (ORR)na wuxuu ahaa 50.0% dhibcaha dhammaan DL-yada. DL4, ORR wuxuu ahaa 57.1%.

Gunaanad: Daraasaddu waxay muujisay muuqaal badbaado oo la maarayn karo iyo dhiirigelinta dhaqdhaqaaqa ka hortagga burooyinka ee C-CAR031 ee bukaanada HCC ee aadka loo daweeyay.

Waqtigan xaadirka ah, waxaa weli jira tijaabooyin caafimaad oo badan oo ku saabsan teknoolojiyada cusub ee ka hortagga kansarka ee Shiinaha oo raadinaya bukaanno. La-tashi ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.

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Tixraacyada

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)