Maarso 1, 2024, Maamulka Badeecadaha Caafimaadka Qaranka ee Shiinaha (NMPA) ayaa ansixiyay soo bandhigidda badeecada unugyada CAR-T ee Zevorcabtagene AutoLeucel (Zevor-cel, CT053) si loogu daaweeyo bukaanada qaangaarka ah ee qaba myeloma badan oo soo noqnoqda ama aan firfircoonayn kuwaas oo horumar sameeyay ka dib ugu yaraan 3 saf oo daaweyn ah (iyadoo la adeegsanayo ugu yaraan hal proteasome inhibitor iyo immunodulator difaaca jirka).
Liiskan wuxuu inta badan ku salaysan yahay tijaabo caafimaad oo furan, gacan keliya, oo weji-dhexe badan leh oo II ah (DARAASADDA LUMMICAR 1,NCT03975907) gudaha Shiinaha, kaas oo gaaray heer cafin 100% ah.
14 bukaan oo da'doodu dhexdhexaad tahay 54 sano (oo u dhaxaysa ：34-62), ayaa hal mar la siiyay daawo zevor-cel ah. Laga bilaabo Luulyo 17, 2023, muddada daaweynta ee dhexdhexaadka ah waxay ahayd 37.7 bilood (oo u dhaxaysa 14.8-44.2 bilood). Heerka jawaab celinta guud (ORR) wuxuu ahaa 100% (14/14) iyadoo 78.6% (11/14) bukaan ay gaareen jawaab dhammaystiran (CR) ama jawaab dhammaystiran oo adag (sCR); tabanaanshaha ugu yar ee cudurka haray (MRD) ayaa laga gaaray dhammaan bukaanada gaaray CR ama sCR. Muddada dhexdhexaadka ah ee jawaab celinta (mDOR) waxay ahayd 24.1 bilood dhammaan bukaanada iyo 26.0 bilood kuwa gaaray CR ama sCR. Badbaadada dhexdhexaadka ah ee aan horumarka lahayn (mPFS) waxay ahayd 25.0 bilood. Wadarta guud ee 7 (50%) bukaan ayaa ku jiray cafis muddo ka badan 24 bilood. Celceliska badbaadada guud (OS) lama gaarin, 92.9% (13/14) bukaannada ayaa weli nool bishii 36.
Badbaadada
Guud ahaan, astaanta badbaadada ee zevor-cel waa la maarayn karaa. Ma jirin dhacdooyin ≥ cytokine sii daynta syndrome (CRS) oo heerka 3aad ah. Ma jirin dhacdooyin neurotoxicity syndrome (ICANS) oo la xiriira unugyada difaaca jirka ee heer kasta. Saddex caabuq oo la xiriira daaweynta ayaa la arkay. Saddex bukaan ayaa la kulmay dhacdooyin halis ah oo aan wanaagsanayn (SAE) oo ay ku jiraan 2 bukaan oo qabay SAE-yo la xiriira daaweynta kuwaas oo ahaa caabuq sambabada ah iyo burooyinka lysis syndrome. Guud ahaan waxaa jiray 2 dhimasho ah oo daraasadda lagu sameeyay; midkoodna lama xiriirin zevor-cel.
Gunaanad
zevor-cel waxay muujisay muuqaal badbaado oo dhiirigelin leh oo leh jawaabo qoto dheer oo waara oo la jaan qaadaya natiijooyinka bilowga ah.
Waqtigan xaadirka ah, waxaa jira tijaabooyin caafimaad oo badan oo CAR-T ah oo ka jira Shiinaha, waxayna raadinayaan bukaanno. Wixii la-tashi ah ee ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing: 4008803716.
Tixraacyada
2.http://sh.news.cn/20240314/2913c85a84be4fbf9345efbd48006971/c.html
3.http://myimm.net/mianyizhiliao/1413.html
4.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20240301143753188.html
Waqtiga boostada: Oktoobar-31-2024