Maarso 2023:
Soo koobid Kooban:
Ujeedada tijaabadan caafimaad waa in la ogaado haddii anti-MESO antigen receptor CAR T-cell daaweynta awooddo loo isticmaalo daawaynta eKansarka pithelial ugxansidaha oo soo noqday ama joojiyay ka jawaabista daawaynta kale.
Faahfaahin faahfaahsan:
Ujeeddooyinka Aasaasiga ah
Si loo go'aamiyo suurtogalnimada iyo badbaadada unugyada anti-MESO CAR-T ee daaweynta bukaannada qaba MESO-positive cancer ovarian.
Ujeedooyinka Labaad
Si loo qiimeeyo waxtarka unugyada anti-MESO CAR-T ee bukaanka qaba kansarka ugxansidaha.
Si loo go'aamiyo dhaqdhaqaaqa in vivo iyo joogtaynta unugyada anti-MESO CAR-T.
Naqshadaynta waxbarashada
Nooca Waxbarasho : Dhexdhexaadin (Tijaab Caafimaad)
Qiyaasta Diiwaangelinta: 20 ka qaybgalayaasha
Qoondaynta: N/A
Qaabka Faragelinta: Meelaynta Koox Kaliya
Maaskarada: Midna (Labelka Furan)
Ujeedada koowaad: Daaweynta
Ciwaanka Rasmiga ah: Badbaadada iyo Waxtarka Unugyada MESO-CAR T ee soo noqoshada iyo dib u soo celinta Kansarka Epithelial Ovarian
Taariikhda Bilowga Daraasadda ee la qiyaasay: Abriil 20, 2019
Taariikhda Dhamaystirka Koowaad ee la qiyaasay: Abriil 20, 2022
Qiyaasta Daraasadda Dhamaystirka Taariikhda: Abriil 20, 2023
Shuruudaha
Shuruudaha ka mid noqoshada:
18 ilaa 70 jir, dumar ah; Badbaadada la filayo> 12 toddobaad; Heerka waxqabadka kiliinikada ee dhibcaha ECOG 0-2; Bukaan-socodka hore loogu daweeyay safka labaad ama in ka badan oo daawaynta caadiga ah ma aha kuwo wax ku ool ah (Ma cafis ama soo noqnoqosho ka dib cafis); Ugu yaraan hal buro foci ah oo la cabbiri karo sida waafaqsan heerka RECIST 1.1; Muujinta Mesothelin ee togan ee unugyada burooyinka; Creatinine ≤ 1.5 × ULN; ALT iyo AST ≤ 3 × ULN; Wadarta bilirubin ≤ 2 × ULN; Hemoglobin≥90g/L; Tirinta buuxda ee neutrophils≥1000uL; Tirinta buuxda ee lymphocytes>0.7×10^9/L; Tirinta platelets≥75000/ul; Helitaanka xididdada loo baahan yahay si loo ururiyo waa la dhisi karaa iyada oo aan la diidin ururinta leukocyte. Waxaan awoodaa inaan fahmo oo aan saxiixo dukumeentiga ogolaanshaha la wargaliyay.
Shuruudaha Ka-saarista:
Oo ay la socdaan burooyin kale oo xun oo aan la xakamayn; Cagaarshowga B ee firfircoon, cagaarshow C, waraabowga, caabuqa HIV; Xanuun daran oo ku dhaca wadnaha iyo xididdada dhiigga; Cudur kasta oo kale ayaa saameyn kara natiijada tijaabadan. Arrimo kasta oo saameyn kara badbaadada maadooyinka ama natiijada tijaabadan Haweenka uurka leh ama nuujinaya, ama bukaanada qorsheynaya inay uur yeeshaan inta lagu jiro ama ka dib daaweynta; Waxaa jira infekshan firfircoon ama aan la xakameyn karin (marka laga reebo caabuqyada fudud ee kaadi mareenka ama caabuqa neef-mareenka sare) kuwaas oo u baahan daaweyn nidaamsan 14 maalmood ama 14 maalmood ka hor shaqada; Bukaan-socodka ay cilmi-baarayaashu ku xisaabtamayaan inaysan ku habboonayn baaritaankan; La helay daawaynta CAR-T ama daawaynta hidda-sidaha kale ka hor meelaynta; Cudurrada la ildaran maaddooyinka waxay saameeyaan fahamka oggolaanshaha la wargeliyey ama u hoggaansanaanta borotokoolka daraasadda.
Hubi liiska cisbitaalada samaynaya CAR T-Cell therapy ee Shiinaha.