satricabtagene autoleucel（Satri-cel,CT041) waa musharax isku-dhafan oo CAR T-cell ah oo ka soo horjeeda borotiinka Claudin18.2 kaasoo leh awood uu ku noqdo heerka koowaad ee adduunka. Satri-cel wuxuu bartilmaameedsadaa burooyinka adag ee Claudin18.2 oo diiradda saaraya kansarka caloosha/kansarka isku-xirka caloosha iyo mindhicirka (GC/GEJ) iyo kansarka ganaca (PC).
Natiijooyinka dabagalka ugu dambeeya ee tijaabada uu bilaabay baaraha CT041-CG4006 (NCT03874897) ee satricaabtagene autoleucel ayaa lagu daabacay Daawada Dabeecadda Juun 3, 2024.
Wadarta 98 bukaan ayaa ka qayb qaatay tijaabada, natiijooyinkuna waxay muujiyeen in heerka xakamaynta cudurku (DCR) uu gaaray 91.8%, 38 bukaan ayaa gaaray cafis, heerka cafis guud wuxuu ahaa 38.8%, heerka badbaadada aan horumarka lahayn (PFS) wuxuu ahaa 4.4 bilood, heerka badbaadada guud ee dhexdhexaadka ah (OS) wuxuu ahaa 8.8 bilood, muddada dhexdhexaadka ah ee cafis (mDOR) wuxuu ahaa 6.4 bilood. 90 bukaan oo bartilmaameed u ah dhaawaca aasaasiga ah, 70 bukaan ayaa gaaray heerar kala duwan oo ah yaraynta burooyinka.
51 bukaan oo qaba kansarka caloosha oo lagu daweeyay daaweyn isku mid ah oo lagu magacaabo Satri-cel, heerka xakamaynta cudurku wuxuu ahaa mid aad u sarreeya ilaa 96.1% (49), heerka jawaab celinta guudna wuxuu ahaa 54.9% (28). Kuwaas waxaa ka mid ah, 27 bukaan ayaa helay jawaab celin qayb ah (PR), 1 bukaan ayaa helay jawaab celin dhammaystiran (CR), muddada dhexdhexaadka ah ee jawaab celinta (mDOR) waxay ahayd 6.4 bilood.
Gunaanad
Satri-cel waxay muujinaysaa awood daaweyn oo leh astaamo badbaado oo la maarayn karo bukaanada qaba kansarka caloosha ee CLDN18.2-positive.
Sebtembar 9, 2023, laba kiis oo lagu daweeyay kansarka ganaca ee faafa iyadoo la adeegsanayo CARsgen's CT041, oo ah daaweyn cusub oo Claudin (CLDN) 18.2 CAR T-cell Therapy, ayaa lagu daabacay Joornaalka Hematology & Oncology oo cinwaan looga dhigay "daaweynta unugyada CAR T ee CT041 ee kansarka ganaca ee faafa ee Claudin18.2".
Kiisaska 1aad, haweeney 58 jir ah ayaa laga helay kansarka ganaca iyadoo la ogaaday inay la ildaran tahay qanjidhada sambabada iyo limfaha. Nab-paclitaxel-ka koowaad iyo gemcitabine iyo irinotecan-liposome-ka labaad iyo 5-flurouracil-ka labaad ayaa lagu guuldareystay ka hor inta aan lagu qorin tijaabada kiliinikada CT041, ka dib markii la xaqiijiyay in CLDN18.2 uu yahay 2+/70%. Ka dib markii lymphodepletion-ka uu ka kooban yahay fludarabine, cyclophosphamide, iyo nab-paclitaxel, waxaa la siiyay qiyaas CT041 ah oo ah 250 × 10.6Unugyada ayaa loo siiyay bukaanka Sebtembar 2021. Cudurka sii deynta cytokine-ka ee heerka 2aad (CRS) ayaa dhacay, kaas oo markii dambe lagu xakameeyay tocilizumab. Jawaabta qayb ahaan (PR) ayaa la gaaray sida ku cad RECIST v1.1, iyadoo si weyn u yaraatay tirada unugyada sambabada.
Kiisaska 2aad, haweeney 75 jir ah ayaa lagu ogaaday kansarka ganaca pT2N0 ka dib markii ay qalliin gashay bishii Maajo 2019. Cudurka sambabada ayaa la ogaaday 5 bilood ka dib markii la sameeyay dabagal joogto ah oo qalliinka ka dib ah. Daaweynta S-1 ee hal-abuurka ah waxaa la siiyay kiimoterabiga safka koowaad laga bilaabo Diseembar 2019. Intii lagu jiray shucaaca palliative-ka aagga qalliinka, horumarka burooyinka ayaa laga arkay sambabka. Maadaama muujinta CLDN18.2 lagu go'aamiyay inay tahay 3+/60%, bukaanka waxaa lagu qoray tijaabada kiliinikada CT041. Ka dib markii la helay lymphopletion oo ka kooban fludarabine, cyclophosphamide iyo nab-paclitaxel, bukaanka waxaa lagu shubay qiyaas CT041 ah oo ah 250 × 106Unugyada bishii Luulyo 2021. Bukaanku wuxuu la kulmay heerka 2aad ee CRS, kaas oo si dheeraad ah loogu xakameeyay tocilizumab. PR ayaa la gaaray tan iyo markii la qiimeeyay 4 toddobaad ka dib markii la geliyay. Nabarrada bartilmaameedka ah ee metastasis-ka sambabada ayaa markii dambe baaba'ay oo la gaaray jawaab dhammaystiran. Burada ayaa weli si fiican loo xakameeyay ilaa la socoshadii ugu dambeysay ee Luulyo 2023. Lambarka nuqulka CLDN18.2 ee dhiigga durugsan ee labada bukaan wuxuu muujiyay koror degdeg ah ka dib markii la geliyay, isagoo ugu sarreeya 2 toddobaad gudahood. Isla mar ahaantaana, natiijooyinka kala soocidda unugyada ee firfircoon ee fluorescence-ka ayaa muujiyay koror ku yimid unugyada dhiigga durugsan ee CD8 T iyo unugyada Treg, oo ay weheliso hoos u dhac ku yimid unugyada T ee CD4 iyo unugyada B. Isbeddelladan ku yimid noocyada unugyada difaaca jirka waxay muujiyeen adkeysi weyn marka la barbar dhigo isbeddellada heerarka cytokine.
Waqtigan xaadirka ah, waxaa jira tijaabooyin caafimaad oo badan oo CAR-T ah oo ka jira Shiinaha, waxayna raadinayaan bukaanno. Si aad ula tashato 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.carsgen.com/en/news/carsgen-presents-updated-results-on-satri-cel-in-nature-medicine-and-at-2024-asco/
2.https://www.nature.com/articles/s41591-024-03037-z
3.https://www.carsgen.com/media/fooloi3a/ct041-cg4006-asco-2024_v3-0_20240603.pdf
4.https://jhoonline.biomedcentral.com/articles/10.1186/s13045-023-01491-9
Waqtiga boostada: Noofambar-21-2024