Badbaadada iyo Waxtarka Barashada Ka-hortagga B7-H3 Daaweynta Unug ee CAR-T ee Glioblastoma Soo noqnoqda

Maarso 2023:

Nooca Waxbarasho : Dhexdhexaadin (Tijaab Caafimaad)
Qiyaasta Diiwaangelinta: 30 ka qaybgalayaasha
Qoondaynta: N/A
Qaabka Faragelinta: Isku-dubarid isdaba-joog ah
Sharaxaadda Qaabka Faragelinta: naqshad "3+3" ayaa loo isticmaalaa si loo go'aamiyo qiyaasta ugu badan ee loo dulqaadan karo (MTD) iyo qiyaasta lagu taliyey ee wajiga 2 (RP2D)
Maaskarada: Midna (Labelka Furan)
Ujeedada koowaad: Daaweynta
Ciwaanka Rasmiga ah: Furan, Gacan-keli ah, Daraasada Wajiga 1 si loo Qiimeeyo Badbaadada/Waxtarka Horudhaca ah lana go'aamiyo qiyaasta ugu badan ee loo dulqaadan karo ee B7-H3-bartilmaameedka CAR-T ee Daaweynta Unugyada Glioblastomas ee soo noqnoqda
Taariikhda Bilowga Waxbarashada Dhabta ah: Janaayo 27, 2022
Taariikhda Dhamaystirka Koowaad ee la qiyaasay: Diseembar 31, 2024
Qiyaasta Daraasadda Dhamaystirka Taariikhda: Diseembar 31, 2024

Marxaladda kordhinta qiyaasta:

Naqshad kordhinta qiyaasta "3+3" ayaa loo isticmaalaa si loo go'aamiyo MTD & R2PD. Anti-B7-H3 autologous Unugyada CAR-T waxa la siiyay bukaanada laba todobaadleba qiyaasaha soo socda ee wareeg kasta, iyo 4 wareegyo sida hal koorso. Qiyaasta 1: 3 bukaan oo qiyaas ah 20 milyan unugyada wareeg kasta. Qiyaasta 2: 3 bukaan oo qiyaas ah 60 milyan unugyada wareeg kasta. Qiyaasta 3: 3 bukaan oo qiyaas ah 150 milyan unugyada wareeg kasta. Qiyaasta 4: 3 bukaan oo qiyaas ah 450 milyan unugyada wareeg kasta. Qiyaasta 5: 3 bukaan oo qiyaas ah 900 milyan unugyada wareeg kasta.

Marxaladda xaqiijinta R2PD:

Go'aami R2PD iyadoo lagu saleynayo natiijooyinka daraasaddii hore ee qiyaasta-kordhinta; Ku dawee 12 bukaan oo kale oo leh anti-B7-H3 autologous Unugyada CAR-T labadii toddobaadba mar ee R2PD si loo sii xaqiijiyo badbaadada R2PD.

Marxalad kasta, haddii bukaanadu muujiyaan dulqaad iyo jawaab celin daaweyntaBukaan-socodkan ayaa heli doona dhowr koorso oo ah daaweynta go'aanka PI.

Shuruudaha

Shuruudaha ka mid noqoshada

1. Lab ama dhedig, da'doodu u dhaxayso 18-75 (oo ay ku jiraan 18 iyo 75 jir)
2. Bukaanka qaba glioblastoma soo noqnoqda, sida lagu xaqiijiyay positron emission tomography (PET) ama pathology histologic
3. A >= 30% staining extent of B7-H3 in his/her primary/recurrent buro tissue by the immunochemical method;
4. Dhibcaha miisaanka Karnofsky>=50
5. Helitaanka ururinta unugyada mononuclear-ka ee dhiigga (PBMCs)
6. Qiimaha shaybaarka oo ku filan iyo shaqada xubnaha oo ku filan;
7. Bukaanka leh kartida ilmo-dhalida/aabbanimada waa in ay oggolaadaan isticmaalka ka-hortagga uur-qaadidda oo aad waxtar u leh.

Shuruudo ka-saaris ah

1. Dumarka uurka leh ama nuujinaya
2. Contraindication to bevacizumab
3. 5 maalmood gudahood ka hor faleebada unugga CAR-T, maadooyinka helaya nidaamka nidaamka isteeroodhyada ee leh qiyaasta ka weyn 10mg/d prednisone ama qiyaasaha u dhigma ee steroids kale (kuma jiraan corticosteroid neefta)
4. Ka-soo-baxa xanuunnada kale ee aan la xakameynin
5. Fayraska difaaca jirka ee firfircoon (HIV), fayraska cagaarshow B, fayraska cagaarshow C ama caabuqa qaaxada;
6. Subjects receiving the placement of a carmustine slow-release wafer within 6 months before the enrollment;
7. Cudurada autoimmune;
8. Qaadashada daawaynta difaaca jirka ee muddada dheer ka dib xubinta taranka;
9. Cudurada dhimirka ee daran ama aan la xakameynin ama xaalad kordhin karta dhacdooyinka xun ama faragelin kara qiimeynta natiijooyinka;
10. Aan laga soo kabsan sunta ama waxyeelada daawaynta hore;
11. Mawduucyada ka qaybqaatay tijaabada dhexgalka kale hal bil gudaheed ka hor intaan la diwaangelin, ama helay daawaynta unugyada kale ee CAR-T ama daawaynta unugyada hiddo-wadaha ka hor intaan la diwaangelin.
12. Mawduucyada xaaladaha caafimaad ee saameeya saxeexa oggolaanshaha qoran ama u hoggaansanaanta hababka cilmi-baarista, oo ay ku jiraan, laakiin aan ku xaddidnayn, cudurrada xididdada maskaxda-maskaxda, kelyaha oo aan shaqeynin / guuldarro, sambabada sambabada, cilladaha xinjirowga, caabuqa habdhiska firfircoon, caabuqa aan la xakameyn, iwm. . al., ama bukaanada aan doonayn ama aan awoodin inay u hoggaansamaan hababka cilmi-baarista;
13. Mawduucyada leh shuruudo kale oo faragelin kara ka qaybgalka tijaabada ee go'aanka baaraha.