Agoosto 7, Xarunta Qiimaynta Daawada (CDE) ee Maamulka Badeecadaha Caafimaadka Qaranka (NMPA) ayaa ku dhawaaqday in duritaanka PA3-17 la soo jeediyay si loogu daro magacaabista daaweynta degdegga ah, oo loogu talagalay daaweynta bukaanada qaangaarka ah ee qaba unugyada T-cell ee soo noqnoqda/iska caabiya leukemia/lymphoma-ka ba'an (r/r T-ALL/LBL).
Waqtigan xaadirka ah, waxaa weli jira tijaabooyin caafimaad oo badan oo ku saabsan teknoolojiyada cusub ee ka hortagga kansarka ee Shiinaha oo raadinaya bukaanno. La-tashi ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.
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Iimayl:myimmnet@163.com
Bukaannada qaba cudurka T-lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL) ee soo noqnoqda/cakiran waxaa si caafimaad ahaan loogu muujiyaa horumarka degdegga ah ee cudurka, saadaasha liidata iyo la'aanta fursadaha daaweynta. Waqtigan xaadirka ah, Nailabine oo keliya ayaa FDA ay ansixisay sannadkii 2005 si loogu daaweeyo bukaannada T-ALL/LBL ee aan ka jawaabin ugu yaraan laba daaweyn oo kiimoterabiga ah ama dib u soo laabtay ka dib daaweynta, iyadoo ORR uu yahay 31% iyo CR oo ah 23%. Sidaa darteed, waxaa jira baahi degdeg ah oo loo qabo in la horumariyo habab kale oo wax ku ool ah. Marka laga reebo muujinta unugyada T iyo NK ee caadiga ah iyo muujinta unugyada kale ee unugyada, CD7 si weyn ayaa loogu muujiyaa unugyada T-ALL/LBL. Sidaa darteed, CD7 waxaa loo arkaa bartilmaameed suurtagal ah oo lagu horumarinayo daaweynta CAR-T ee T-ALL/LBL. Si kastaba ha ahaatee, caqabadda ayaa ah in laga fogaado fratricide oo ay keento muujinta CD7 ee unugyada T. Cilmi-baarayaashu waxay sameeyeen duritaan unug CAR-T ah oo ku salaysan unugyada difaaca jirka ee CD7 nano, oo loogu magac daray duritaanka PA3-17, iyagoo xannibaya muujinta molecule-ka CD7 ee dusha sare ee unugyada T iyada oo loo marayo xannibaadaha muujinta borotiinka ee ka hortagga CD7 (PEBL).
Xogta dabagalka muddada dheer ee laga helay tijaabada kiliinikada ee Wajiga I ee duritaanka PA3-17 ee loogu talagalay daaweynta unugyada T-cell ee soo noqnoqda/iska caabiya leukemia/lymphoma-ka ba'an ee lymphoblastic (R/R T-ALL/LBL) ayaa lagu soo bandhigay shirkii waxbarasho ee caalamiga ahaa ee EHA 2025.
Laga bilaabo Febraayo 19, 2025, wadarta 13 bukaan ayaa la diiwaan geliyay (3 bukaan oo ku jira qiyaasta 1, 2, 3 koox, 4 bukaan oo ku jira kooxda RP2D), dhammaantoodna waxay heleen hal duritaan oo ah PA3-17 waxayna dhammaystireen qiimeyn 28-maalmood ah oo xaddidaysa sunta (DLTs). RP2D waxaa lagu aasaasay 2×10⁶ CAR-T/kg iyadoo lagu saleynayo farmasokinetics, badbaadada iyo waxtarka ka baxsan qiyaastan. Ma jirin DLTs oo dhacay mana la gaarin qiyaasta ugu badan ee loo dulqaadan karo (MTD). Cudurka sii deynta Cytokine (CRS) wuxuu ahaa 84.6% (G3:23.1%, ma jirin G4), halka cudurka neurotoxicity-ga ee la xiriira unugyada saamaynta difaaca jirka (ICANS) uu ku koobnaa G1-2 (15.4%). Xogta waxtarka leh waxay muujisay in heerka jawaab celinta ugu fiican ee ujeeddada leh (ORR) uu ahaa 84.6% (11/13) iyo 76.9% (10/13) ay gaareen cafis dhammaystiran/cafis dhammaystiran iyadoo la soo kabsanayo tirinta aan dhammaystirnayn (CR/CRi). Si la yaab leh, 69.2% (9/13, 8 bukaan CR) waxay sii wadeen jawaab celintooda 3 bilood, iyadoo 50.0% (4/8) ay sii wadeen CR⼞15 bilood ka dib markii la geliyay iyada oo aan la tallaalin unugyada asliga ah ee xiga (SCT), laba ka mid ahna weli waxay lahaayeen unugyo CAR-T ah oo la ogaan karo 21 bilood. Waxaa xusid mudan, bukaan si weyn loo daaweeyay [kahor Beerista Unugyada Aasalka ah ee Hematopoietic (HSCT), oo ah cudur weyn ⼞7cm] wuxuu gaaray CR maalintii 28aad iyo HSCT-gii labaad 6 bilood.
Duritaanka PA3-17 wuxuu muujiyay dulqaad wanaagsan, firfircooni caafimaad oo qoto dheer oo joogto ah bukaanada r/r T-ALL/LBL ee si aad ah loo daaweeyay, iyadoo 50% bukaanada CR ay sii jiraan badbaado ama/iyo horumar la'aan 1 sano gudahood.
Waqtigan xaadirka ah, waxaa weli jira tijaabooyin caafimaad oo badan oo ku saabsan teknoolojiyada cusub ee ka hortagga kansarka ee Shiinaha oo raadinaya bukaanno. La-tashi ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.
Lambarka Taleefanka: 4008803716
Aqoonsiga WeChat: 17801183037
Email：myimmnet@163.com
Waqtiga boostada: Agoosto-13-2025