Luulyo 20keeda, Codsiga Cusub ee Daawada(NDA) ee pCAR-19B oo ay si madax-bannaan u samaysay Precision Biology waxaa si rasmi ah u aqbalay Maamulka Badeecadaha Caafimaadka Qaranka ee Shiinaha (NMPA). Badeecadani waa badeecaddii ugu horreysay ee CAR-T ee loogu talagalay leukemia carruurnimada ee Shiinaha, taas oo loo isticmaalo in lagu daaweeyo bukaannada da'doodu u dhaxayso 3-21 ee qaba leukemia lymphoblastic acute oo soo noqotay/ceebowday oo CD19-positive ah (ALL).
Leukemia-ga lymphoblastic ee daran (ALL) waa mid ka mid ah burooyinka ugu badan ee carruurta ku dhaca waana sababta ugu weyn ee dhimashada carruurta iyo dhallinyarada. Daaweynta unugyada chimeric antigen receptor (CAR-T) waxay kacaan ka samaysay daaweynta unugyada B-cell ee soo noqnoqda/aan firfircoonayn (R/R) ALL, iyadoo la adeegsanayo badeecaddii ugu horreysay ee FDA ay ansixisay, Kymriah (tisagenlecleucel) oo ay soo saartay Novartis, taasoo si weyn u wanaajisay heerarka cafinta iyo waqtiyada badbaadada.
pCAR-19B waa badeeco unug CAR-T ah oo iskeed u shaqeysa oo leh jajab doorsoome hal silsilad ah oo CD19 gaar ah oo la habeeyay (scFv) oo loogu talagalay in wax looga qabto walaacyada badbaadada.
Bishii Nofeembar 2023, pCAR-19B waxaa la siiyay "Magacaabista Daaweynta Horumarka leh" Maamulka Badeecadaha Caafimaadka Qaranka ee Shiinaha si loogu daaweeyo B-ALL.
Waxtarka iyo natiijooyinka badbaadada ee pCAR-19B ee tijaabada caafimaad ee muhiimka ah ee ku lug leh carruurta Shiinaha iyo bukaanada qaangaarka ah ee da'da yar ee qaba unugyada R/R B DHAMMAANlagu dhawaaqay atShirkii Sanadlaha ahaa ee 66-aad ee Ururka Cudurrada Dhiigga ee Mareykanka (ASH).
Hababka: Tijaabadan wejiga 2aad (NCT05334823) waxay ahayd daraasad hal gacan ah, calaamad furan, oo xarumo badan lagu sameeyay. Bukaannada da'doodu u dhaxayso ≥ 3 iyo ≤ 21 sano oo lagu baarayay CD19+ R/R B-ALL oo la xaqiijiyay ayaa lagu daray. Ujeeddada ugu weyn waxay ahayd heerka guud ee cafinta (ORR), oo lagu qeexay cafinta buuxda (CR) iyo CR oo leh soo kabashada dhiigga oo aan dhammaystirnayn (CRi) 3 bilood gudahood ka dib galinta.
Natiijooyinka: Laga bilaabo Abriil 18, 2024, 89 bukaan ayaa la diiwaan geliyay waxaana la mariyay leukapheresis, iyadoo 64 bukaan ay qaateen daawada pCAR-19B. Ma jirin kiisas ku saabsan cillad soo saar. Bukaannada la siiyay daawada, 6.25% (4/64) waxay ahaayeen kuwo aan firfircooneyn halka 93.75% (60/64) ay dib ugu soo laabteen dhowr jeer oo daaweyn hore ah ama tallaalidda unugyada asliga ah ee allogeneic. Da'da dhexe waxay ahayd 11 sano (inta u dhaxaysa 3-21), 56.25% (36/64) waxay ahaayeen rag. Intaa waxaa dheer, 75% (48/64) bukaannada ayaa qaaday ugu yaraan hal hiddo-wade oo khatar sare leh. Culayska qaraxa dhuuxa lafta ee dhexdhexaadka ah (BM) ee bilowga ah wuxuu ahaa 58.3% (inta u dhaxaysa 5%-98%) iyadoo culayska qaraxa BM ee culus (≥50%) lagu arkay 56.25% bukaannada.
Dabagal dhexdhexaad ah oo socday 211 maalmood (inta u dhaxaysa 35-750), ORR-ka ugu fiican wuxuu ahaa 90.63% (58/64), iyadoo 78.13% bukaannada (50/64) ay gaareen CR iyo 12.5% bukaannada (8/64) ay gaareen CRi, taasoo ka sarreysa waxtarka badeecadaha ganacsiga ee daaweynta CAR-T ee ka hortagga CD19 ee lagu soo sheegay R/R B-ALL. 98.27% (57/58) bukaannada qaba ORR waxay gaareen xanuun yar oo taban (MRD) - cafis taban. ORR-ka 3 bilood wuxuu ahaa 76.56% (49/64). Muddada dhexdhexaadka ah ee jawaabta (DOR) waxay ahayd 10.61 bilood (95% isku-kalsoonaanta 7.66-20.96). Badbaado guud oo dhexdhexaad ah (OS) waxay ahayd 23.92 bilood (95% isku-kalsoonaanta 9.86-NR).
Cudurka sii deynta Cytokine (CRS) iyo cudurka neurotoxicity-ga ee la xiriira unugyada difaaca jirka (ICANS) ayaa ka dhacay 98.44% iyo 50% bukaanada, siday u kala horreeyaan. Heerka ≥3 CRS iyo ICANS waxaa lagu arkay 29.69% iyo 39.06% bukaanada, siday u kala horreeyaan. Muddada dhexdhexaadka ah ee heerka ≥3 CRS iyo ICANS waxay ahayd 4 maalmood iyo 3 maalmood, siday u kala horreeyaan. Ma jirin dhimasho loo aaneeyay CRS ama ICANS.
Gunaanad: Iyadoo ay jiraan culeys culus oo qaraxyada BM ah iyo khatar sare oo ah kala duwanaansho hidde ah, pCAR-19B waxay muujisay heerar cafin sare, waxay gaartay heer sare oo cafin ah oo MRD-negative ah, jawaabo waara, iyo astaan badbaado oo la dulqaadan karo. Daraasaddani waxay matalaysaa tijaabadii caafimaad ee ugu horreysay ee muhiimka ah ee carruurnimada B-ALL ee dadka Aasiya, iyadoo bixinaysa ikhtiyaar daaweyn cusub oo loogu talagalay bukaanada carruurta Shiinaha iyo kuwa da'da yar ee qaba R/R B-ALL.
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.
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Tixraacyada
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.http://cq.news.cn/20240728/b0a74788930d4be7a45996be2808dd4f/c.html
4.https://ash.confex.com/ash/2024/webprogram/Paper206408.html
5.https://ashpublications.org/blood/article/140/Supplement%201/4625/491174/The-Safety-and-Efficacy-of-p-CAR-19B-a-Scfv
Waqtiga boostada: Noofambar-22-2024