satri-cel (CT041) waxaa lagu daray daawo daaweyn oo horumarsan oo ay soo saartay Maamulka Badeecadaha Caafimaadka Qaranka

Febraayo 21, 2025, Xarunta Qiimaynta Daawada (CDE) ee Maamulka Badeecadaha Caafimaadka Qaranka ee Shiinaha (NMPA) ayaa ogolaatay Magacaabista Daaweynta Degdegga ah (BTD) ee Satri-cel(CT041) (oo ah musharax isku-dhafan oo CAR T-cell ah oo ka dhan ah Claudin18.2), si loogu sameeyo adenocarcinoma-ga caloosha/hunguriga oo horumarsan (G/GEJ) oo leh muuqaal togan oo ah Claudin18.2 (CLDN18.2) oo hore ugu guuldareysatay ugu yaraan daaweynta safka labaad.

Tijaabada uu bilaabay baaraha CT041-CG4006 (NCT03874897) ee satricaabtagene autoleucel ("satri-cel", CT041) (oo ah musharax isku-dhafan oo CAR T-cell ah oo ka dhan ah Claudin18.2) ayaa lagu daabacay Daawada Dabeecadda Juun 3, 2024.

Tijaabadan waxaa ka mid ahaa marxaladda kor u kaca qiyaasta (n = 15) iyo marxaladda fidinta qiyaasta ee afar kooxood oo kala duwan (wadarta n = 83): kooxda 1, daaweynta monotherapy-ga satri-cel ee 61 bukaan oo qaba kansarka caadiga ah ee kiimoterabiga-ka-hortagga caloosha; kooxda 2, daaweynta satri-cel iyo ka-hortagga PD-1 ee 15 bukaan oo qaba kansarka caadiga ah ee kiimoterabiga-ka-hortagga caloosha; kooxda 3, satri-cel sida daaweyn isku xigta ka dib daaweynta safka hore ee shan bukaan oo qaba kansarka caloosha; iyo kooxda 4, daaweynta monotherapy-ga satri-cel ee laba bukaan oo qaba kansarka caloosha ee ka-hortagga-CLDN18.2 monoclonal antibody-ka-diidka ah. Ujeeddada ugu weyn waxay ahayd badbaadada; dhidibka dambe ee labaad waxaa ka mid ahaa waxtarka, farmasokinetics iyo difaaca jirka. Wadarta 98 ​​bukaan ayaa la siiyay faleebo satri-cel ah, kuwaas oo 89 ka mid ah lagu siiyay 2.5 × 108, lix leh 3.75 × 108 iyo saddex leh 5.0 × 108 unugyada CAR T. Dabagalka dhexdhexaadka ah wuxuu ahaa 32.4 bilood (95% muddada kalsoonida (CI): 27.3, 36.5) tan iyo markii la ogaaday in uu qabo cudurka. Lama soo sheegin sunta xaddidaysa qiyaasta, dhimashada la xiriirta daaweynta ama cudurka neerfaha ee la xiriira unugyada saameeya difaaca jirka. Cudurka sii deynta Cytokine wuxuu ka dhacay 96.9% bukaanada, dhammaantoodna waxaa loo kala saaray heerka 1-2. Dhaawacyada xuubka caloosha ayaa lagu aqoonsaday siddeed (8.2%) bukaanada. Heerka jawaab celinta guud iyo heerka xakamaynta cudurka ee dhammaan 98 bukaan waxay ahaayeen 38.8% iyo 91.8%, siday u kala horreeyaan, badbaadada dhexdhexaadka ah ee aan horumarka lahayn iyo badbaadada guudna waxay ahaayeen 4.4 bilood (95% CI: 3.7, 6.6) iyo 8.8 bilood (95% CI: 7.1, 10.2), siday u kala horreeyaan. Satri-cel wuxuu muujinayaa awood daaweyn oo leh astaamo badbaado oo la maareyn karo bukaanada qaba kansarka caloosha ee horumarsan ee CLDN18.2-positive.

Ku saabsan Satri-cel

Satri-cel waa tijaabo caafimaad oo isku-dhafan oo CAR T-cell ah oo ka dhan ah borotiinka Claudin18.2 kaasoo leh awood uu ku noqdo heerka koowaad ee adduunka. Satri-cel wuxuu bartilmaameedsadaa daaweynta burooyinka adag ee Claudin18.2 iyadoo diiradda la saarayo kansarka caloosha/kaankarada isku-xidhka caloosha iyo mindhicirka (GC/GEJ) iyo kansarka ganaca (PC). Tijaabooyinka socda waxaa ka mid ah tijaabooyin ay bilaabeen baarayaashu (CT041-CG4006, NCT03874897), tijaabo caafimaad oo xaqiijinaysa wejiga labaad ee GC/GEJ ee horumarsan ee Shiinaha (CT041-ST-01, NCT04581473), tijaabo caafimaad oo wejiga koowaad ah oo loogu talagalay daaweynta PC-ga ee Shiinaha (CT041-ST-05, NCT05911217), iyo tijaabo caafimaad oo wejiga 1b/2 ah oo loogu talagalay adenocarcinoma caloosha ama ganaca ee horumarsan ee Waqooyiga Ameerika (CT041-ST-02, NCT04404595). Satri-cel waxaa US FDA u aqoonsatay Regenerative Medicine Advanced Therapy (RMAT) oo loogu talagalay daaweynta GC/GEJ ee horumarsan oo leh burooyinka Claudin18.2-positive bishii Janaayo 2022, waxaana EMA u ogolaatay PRIME inay u qalanto daaweynta kansarka caloosha ee horumarsan bishii Nofeembar 2021. Satri-cel waxay heshay magacaabista Daawada Agoonta ee US FDA sanadkii 2020 si loogu daaweeyo GC/GEJ iyo magacaabista Daawada Agoonta ee EMA sanadkii 2021 si loogu daaweeyo kansarka caloosha ee horumarsan.

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.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

2.Unugyada CAR T ee gaarka ah ee Claudin18.2 ee kansarka caloosha iyo mindhicirka: natiijooyinka kama dambaysta ah ee tijaabada wejiga 1 | Daawada Dabeecadda

3.Bogga Hore | CARsgen