Mayu 2022: FDA ta amince da aikace-aikacen gwaji na asibiti na takamaiman magani na CAR-NK FT536 a cikin maganin ciwace-ciwace a cikin gwajin asibiti na CAR-NK. FDA ta amince da Sabuwar Aikace-aikacen Magunguna na Bincike a cikin Janairu 2022 don maganin CAR-NK FT536 don kula da mutanen da suka sake dawowa ko juriya mai ƙarfi. A cikin wannan gwaji, marasa lafiya masu ciwon huhu marasa ƙananan ƙwayoyin cuta, ciwon daji na launi, ciwon kai da wuyansa, ciwon ciki, ciwon nono, ciwon daji na ovarian, da ciwon daji na pancreatic za su karbi FT536 a matsayin monotherapy ko a hade tare da kwayar cutar monoclonal. FT536 (Ƙaddara Therapeutics) wani allogeneic ne, mai yin kisa na halitta da yawa (NK) maganin tantanin halitta da aka samar daga ƙwanƙwarar ƙwayoyin kara kuzari.
Wannan magani ne da aka yi amfani da shi ta hanyar kwayoyin halitta NK wanda ke bayyana CAR wanda ke yin hari ga yankunan alpha-3 na MICA da MICB, sunadaran sunadarai guda biyu da ke da hannu a cikin manyan nau'o'in histocompatibility hadaddun I. Dukansu sunadaran sunadaran damuwa waɗanda aka samar da su sosai a yawancin ciwace-ciwacen ciwace-ciwace kuma suna iya shawo kan su. zubar don dawo da rigakafi na ƙari wanda NK da T sel suka shiga tsakani. Gabaɗaya, FT536 ya ƙunshi gyare-gyare na aiki guda huɗu: Motar mallakar mallakar MICA da yankin 3 na MICB; wani labari mai girma na 158V, CD16 maras iyawa (hnCD16) Fc mai karɓa wanda ke haɓaka ADCC; yana inganta haɓakar ƙwayoyin NK Active IL-15 fusion mai karɓa (IL-15RF); da kawar da maganganun CD38, don haka inganta lafiyar NK cell metabolism, dagewa, da aikin antitumor.
We expect that FT536 therapy can obtain positive data as soon as possible in clinical trials of solid ciwan kansa, and it will be launched as soon as possible to benefit patients.
