Luulyo 30, Maamulka Badeecadaha Caafimaadka Qaranka (NMPA) ayaa si rasmi ah u ansixiyay suuqgeynta HICARA ee daaweynta bukaanada qaangaarka ah ee qaba lymphoma-ka unugyada B ee soo noqnoqda ama kuwa aan firfircoonayn (r/r LBCL) kuwaas oo helay laba ama in ka badan oo daaweyn nidaamsan. Tan waxaa ka mid ah lymphoma-ka unugyada B ee ballaaran ee faafinta, oo aan si kale loo cayimin (DLBCL, NOS); lymphoma-ka unugyada B ee ballaaran ee faafinta oo laga beddelay lymphoma-ka follicular; lymphoma-ka unugyada B ee heerka sare ah oo leh dib-u-habaynta MYC iyo BCL2; iyo lymphoma-ka unugyada B ee heerka sare ah, oo aan si kale loo cayimin (HGBL, NOS).
Tani waxay calaamad u tahay badeecaddii ugu horreysay ee si buuxda loo horumariyay ee CD19 CAR-T ee Shiinaha oo si gaar ah loogu bartilmaameedsaday lymphoma-ka unugyada B ee soo noqnoqda ama aan firfircoonayn (r/r LBCL). Cilmi-baarista, horumarinta, iyo soo saarista HICARA waxay si buuxda ugu tiirsan tahay naqshadda molecular-ka ee gaarka ah ee Hrain Biotechnology, nidaamka tayada habka si madax-bannaan loo aasaasay, iyo madal wax soo saar oo ballaaran oo xiran. Guushani waxay xaqiijinaysaa helitaanka buuxa ee horumarinta iyo soo saarista unugyada CAR-T, iyadoo jebinaysa kalitalisnimada tignoolajiyada shisheeye. Waxaa xusid mudan, HICARA waa badeecaddii ugu horreysay ee gudaha laga ansixiyay ee CAR-T ee qaadata habka vector-ka fayraska ee khadka unugyada oo deggan.
Sida laga soo xigtay natiijooyinka tijaabada Wejiga II HRAIN01-NHL01-II (NCT05436223) ee la soo bandhigay intii lagu jiray Shir-sannadeedka Ururka Cilmi-baarista Kansarka ee Mareykanka (AACR) ee 2024, HICARA waxay muujisay jawaabo wax ku ool ah bukaanada qaba lymphoma-ka aan ahayn Hodgkin ee soo noqnoqda/cakiran.
Natiijooyinka: Laga bilaabo Maajo 16, 2023, 81 bukaan oo R/R NHL ah oo qaba ECOG 0-1 bilowga ah ayaa laga helay HR001 faleebada xarunta wax soo saarka Jinshan [51.9% lab ah; da'da dhexdhexaadka ah 53.4 sano (u dhaxaysa 23 ~ 74); 3.7% CD19 taban; 91.4% buro buro ah oo B-unug ah; 79.0% III-IV ee kala soocidda Ann Arbor ama Lugano] iyadoo la raacayo dhexdhexaad ah 160 maalmood (u dhaxaysa 7 ilaa 454). Waqtiga dhexdhexaadka ah ee jawaabta ugu fiican wuxuu ahaa 30 maalmood (u dhaxaysa 28-358). Heerka jawaabta ugu fiican ee 3-bilood, 6 bilood iyo heerka jawaabta ugu fiican (ORR) wuxuu ahaa 53.1% (95% CI: 41.7-64.3), 45.7% (95% CI: 34.6-57.1) iyo 74.1% (95% CI: 63.1-83.2) siday u kala horreeyaan. Heerka jawaabta ugu fiican ee 3-bilood, 6 bilood iyo heerka jawaab celinta ugu buuxda (CRR) wuxuu ahaa 32.1% (95% CI: 22.2-43.4), 29.6% (95% CI: 20.0-40.8) iyo 49.4% (95% CI: 38.1-60.7) siday u kala horreeyaan. Muddada dhexdhexaadka ah ee jawaabta (DOR) iyo badbaadada aan horumarka lahayn (PFS) waxay ahaayeen 339 maalmood (95% CI: 149-NE) iyo 176 maalmood (95% CI: 91-NE) siday u kala horreeyaan. Badbaadada guud (OS) lama gaarin. Dhacdooyinka ugu badan ee la xiriira daaweynta (AEs) waxay ka dhaceen nidaamka dhiigga. Cudurka sii deynta cytokine (CRS) wuxuu ka dhacay 95.1% bukaanada, iyadoo CRS ≥3 darajo lagu arkay 3.7% bukaanada. Cudurka neerfaha ee la xiriira unugyada difaaca jirka (ICANS) wuxuu ku dhacay 8.6% bukaanada, iyada oo aan la soo sheegin wax ICANS ah oo heerka 3aad ah. Dhimashada la xiriirta daaweynta waxay ahayd 1.2%. Waqtiga dhexdhexaadka ah ee fidinta ugu sarreysa ee unugyada CAR T wuxuu ahaa 240 saacadood (120 ~ 672) ka dib markii la geliyay, fidinta ugu badan ee dhexdhexaadka ah (Cmax) wuxuu ahaa 17413.9 nuqul/μg DNA (124.9 ~ 136382.2), iyo dhexdhexaadka AUC0-28dwuxuu ahaa 3201014.0 nuqul/μg DNA (205082.8~18400016.2). Tijaabooyinka togan ee antibody-ka ka hortagga daroogada (ADA) ayaa lagu arkay 14.8% bukaanada, halka baaritaannada antibody-ga dhexdhexaadka ah (Nab) ay ahaayeen kuwo togan 3.7% bukaanada. Bukaannada Nab-ku-saleysan, jawaabta oo dhammaystiran ayaa la sii waday ilaa dabagal.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department. Phone Number：4008803716 WeChat ID: 17801183037 Email：myimmnet@163.com
Waqtiga boostada: Luulyo-31-2025