RD13-02 waa badeeco unug CAR-T oo caalami ah oo bartilmaameedsanaysa CD7 oo laga soo qaatay deeq-bixiyeyaal caafimaad qaba, waxaana loogu talagalay daaweynta unugyada T-cell ee soo noqnoqda ama aan firfircoonayn ee lymphoblastic leukemia/lymphoma (T-ALL/LBL). Waxaa hidde ahaan loo beddelay si looga fogaado fratricide, cudurka graft-versus-host (GvHD), iyo diidmada marti-gelinta-ka-hortagga-burooyinka (HvG) iyadoo la xoojinayo dhaqdhaqaaqa ka-hortagga burooyinka. RD13-02 waxaa lagu diyaarin karaa hal dufcadood oo loogu talagalay dad badan, iyadoo la gaarayo awood "aan la heli karin" oo loogu talagalay bukaanada u baahan daaweynta unugyada CAR-T.
Noofambar 7, 2024, Bioheng Therapeutics waxay ku dhawaaqday inay soo bandhigi doonto xogtii ugu dambeysay ee caafimaad ee Wejiga I ee badeecadeeda guud ee unugyada CAR-T RD13-02, oo bartilmaameedsanaysa CD7 si loogu daaweeyo bukaanada T-ALL/LBL ee soo noqnoqda/dib u dhaca/cakiran (R/R), iyadoo lagu soo bandhigayo khudbad afka ah oo ka dhacaysa Shirka Sanadlaha ah ee 66-aad ee Bulshada Maraykanka ee Dhiigga (ASH). Shirku wuxuu dhici doonaa laga bilaabo Diseembar 7-10, 2024, San Diego, USA.
Natiijooyinka: Laga bilaabo Agoosto 1, 2024, wadarta 18 dhibcood oo u qalma oo leh R/R T-ALL/LBL ayaa la diiwaangeliyey (13 DHAMMAAN, 5 LBL), iyadoo da'doodu dhexdhexaad tahay 33.5 sano (inta u dhaxaysa, 11 ilaa 67). Daawaynta hore ee dhexdhexaadka ah waxay ahayd 2 (inta u dhaxaysa, 1 ilaa 5), 4 dhibcoodna waxay lahaayeen allo-HSCT ka hor diiwaangelinta. Saamiga dhexdhexaadka ah ee qaraxyada BM wuxuu ahaa 71% (inta u dhaxaysa: 6% ilaa 90%) 18 dhibcood, iyadoo 9 (6 DHAMMAAN, 3 LBL) ay muujinayaan ku lug lahaanshaha ka baxsan medullary. Ma jirin wax sun ah oo xaddidaysa qiyaasta (DLT) ama sunta neerfaha ah oo lagu arkay dhammaan heerarka qiyaasta, iyadoo hal kiis oo keliya oo ah Gr1 GvHD uu dhacay. Cudurka sii deynta Cytokine (CRS) waa la maarayn karay iyadoo inta badan ay ahaayeen kuwo fudud (Gr1, n=10; Gr2, n=5; Gr3, n=3). Caabuq kasta oo heer kasta ah ayaa ka dhacay 13 (72%) dhibcood (≥Gr3 2 [11%] dhibcood). Sababtoo ah dhacdada Gr3 CRS hal dhibcood midkiiba heerarka DL2 iyo DL3, baarayaashu waxay DL1 u dejiyeen qiyaas ballaarin ah iyagoo diiradda saaraya badbaadada iyo waxtarka. Inta lagu jiro ballaarinta qiyaasta, hal dhibcood ayaa u dhintay cudurka burooyinka maalintii 20aad ka dib markii la geliyay.
Qiimaynta bilowga ah ee 28-ka maalmood ah ka dib markii la geliyay, 14 ka mid ah 17 dhibcood oo la qiimayn karo ayaa gaaray CR/CRi. Intii lagu jiray bishii 2aad ee la geliyay ka dib, laba dhibcood oo kale ayaa gaaray CR/CRi, iyadoo heerka CR/CRi uu yahay 94% (16/17). Mid ka mid ah dhibcaha qaba CR/CRi, 100% waxay gaareen heerka ugu yar ee cudurka haray (MRD) iyadoo la adeegsanayo falanqaynta socodka cytometry. Cmax-ka dhexdhexaadka ah ee unugyada CAR-T ee dhiigga durugsan wuxuu ahaa 1,863,601 nuqul/μg DNA-da genomic (kala duwanaanshaha, 275,044 ilaa 3,763,587) qPCR, iyadoo muddada ugu dheer ay dhaaftay 90 maalmood.
Gunaanad: RD13-02, oo ah badeecad CAR-T oo caalami ah oo "aan la heli karin", waxay muujisay muuqaal badbaado oo la maarayn karo iyo waxtar la xoojiyay oo lagu daaweynayo R/R CD7 T-ALL/LBL. Waxaa xusid mudan, 100% CR/CRi pts waxay gaareen xaalad taban oo MRD ah, iyagoo bixinaya fursado daaweyn oo degdeg ah.
Waqtigan xaadirka ah, waxaa jira tijaabooyin caafimaad oo badan oo CAR-T ah oo ka jira Shiinaha, waxayna raadinayaan bukaanno. Si aad ula tashato daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.
Lambarka Taleefanka: 4008803716
Email：myimmnet@163.com
Tixraacyada
1.https://www.bioheng.com/News_Details/26.html
2.https://ash.confex.com/ash/2024/webprogram/Paper207322.html
3.http://myimm.net/mianyizhiliao/2035.html
Waqtiga boostada: Diseembar-03-2024