Oktoobar 11, 2024, Maamulka Qaranka ee Waxsoosaarka Caafimaadka ee Shiinaha (NMPA) ayaa ansixiyay codsiga Baaritaanka Daawada Cusub (IND) ee loogu talagalayInaticabtagene Autoleucel (CNC19 Duritaanka), oo ah daaweyn unugyada T-ga ee soo-dhoweeyaha unugyada isku-dhafan ee CD19-ku-beegsanaya, si loogu daaweeyo xinjirowga dhiigga ee difaaca jirka ee lupus erythematosus-ka nidaamsan (SLE – ITP). Kani waa IND-gii ugu horreeyay ee Inaticabtagene Autoleucel oo loo ansixiyey cudurka isdifaaca jirka ee Shiinaha.
Inaticabtagene Autoleucel waa badeeco daaweyn unug oo CD19 CAR-T ah, oo lagu soo bandhigay CD19 scFv（HI19a） gaar ah iyo habab wax soo saar oo horumarsan. Inaticabtagene Autoleucel waa badeecaddii ugu horreysay ee gaarka loo leeyahay ee CAR-T ee lagu beero gudaha Shiinaha, waana badeecaddii ugu horreysay ee daaweynta unugyada CAR-T ee ganacsiga loogu talagalay B-ALL ee Shiinaha. Inaticabtagene Autoleucel waxay ballaarinaysaa codsigeeda dhowr tilmaamood, oo ay ku jiraan r/r dadka waaweyn B-ALL, r/r DLBCL, carruurta iyo dhallinyarada r/r B-ALL, iyo cudurro kala duwan oo isdifaac ah. Codsiga Dawada Cusub (NDA) ee daaweynta Lymphoma-ka B-Cell ee La Soo Noqdo ama La Iska Caabin karo waxaa aqbalay NMPA bishii Sebtembar 2024.
SLE waa cudur ku dhaca difaaca jirka oo nidaamsan, kaasoo badanaa sababa dhaawac badan oo xubnaha ah. Unugyada B ee aan caadiga ahayn iyo unugyada difaaca jirka ee iswada ayaa door muhiim ah ka ciyaara cudurka SLE. SLE waxay sababi kartaa burbur xad dhaaf ah oo platelet ah, gaar ahaan SLE-ITP. SLE-ITP waxay ku dhacdaa qiyaastii 16% bukaanada Shiinaha ee SLE, inta badan bukaanada SLE-ITP waxay si aad ah uga jawaabaan steroids, immunoinhibitors, iyo daawooyinka bayoolojiga, badanaana waxay la kulmaan khatar weyn oo dhiigbax xubnaha ah, halka badbaadadooda muddada dheer ay aad u liidato.
Bishii Luulyo ee sanadkan, joornaalka caanka ah ee "The New England Journal of Medicine"Daraasad lagu daabacay "Unugyada T-ga ee Ka-hortagga CD19 ee ku jira xinjirowga difaaca jirka ee SLE," oo ay si wada jir ah u qoreen Professor Zeng Xiaofeng iyo Professor Li Mengtao oo ka socda Waaxda Rheumatology iyo Professor Zhou Daobin oo ka socda Waaxda Dhiigga ee Isbitaalka Kulliyadda Caafimaadka ee Peking Union. Daraasaddu waxay muujisay waxtarka muddada dheer iyo badbaadada Inaticaabtagene Autoleucel ee daaweynta SLE-ITP, iyadoo iftiiminaysa awoodda weyn ee daaweynta unugyada CAR-T.
Haweeney 38 jir ah ayaa lagu ogaaday SLE sanadkii 2014 waxayna la kulantay borotiin la celin karo iyo kala-goysyo iyo thrombocytopenia joogto ah. Daawayntii hore ee lagu sameeyay glucocorticoids-ka qiyaasta sare leh (methylprednisolone pulses), hydroxychloroquine, immunoglobulin-ka xididka, tacrolimus, cyclosporin A, sirolimus, rituximab, danazol, eltrombopag, iyo thrombopoietin-ka aadanaha ee dib loo habeeyay ma aysan yareynin thrombocytopenia. Tirada platelets-ka waxaa la ilaaliyay 10,000 ilaa 20,000 halkii milimitir cubic ah ugu dambeyntiina waxay hoos uga dhacday 10,000 halkii milimitir cubic bishii Luulyo 2023.
Waqtigaas, waxay la kulantay purpura iyo ecchymoses addimadeeda, nabaro dhiigga afka ah, iyo dhiigbax ku dhaca ciridka. Baaritaanka dhuuxa lafta ayaa muujiyay myeloproliferation firfircoon iyo cillad ku timid bislaanshaha megakaryocyte. Kaliya prednisone oo qiyaas yar leh (5 mg maalintii) iyo hydroxychloroquine (0.2 g maalintii) ayaa la siiyay bishii ka horreysay gelinta unugyada CAR T. Leukapheresis cusub oo iskiis ah ayaa loo isticmaalay in lagu soo saaro inati-cel. Wadarta 500,000 oo unugyada CAR T CD19 halkii kiilo ee miisaanka jidhka ayaa la siiyay ka dib markii bukaanku uu maray kiimoterabiga lymphodepleting oo leh fludarabine (qiyaas dhan 25 mg halkii mitir laba jibbaaran oo aagga dusha sare ee jirka ah) maalintii maalmaha −5, −4, iyo −3 iyo cyclophosphamide (qiyaas dhan 250 mg halkii mitir laba jibbaaran) maalmaha −5 iyo −4 ka hor daaweynta unugyada CAR T.
Ka dib markii la duray Inaticabtagene Autoleucel, tirada platelets-ka bukaanka ayaa sii kordhaysay, waxaana la gaaray jawaab dhammaystiran oo caafimaad, glucocorticoids-ka iyo dhammaan daawooyinka difaaca jirka joojiya ayaa la joojiyay. Waqtigan xaadirka ah, bukaanku wuxuu asal ahaan ku soo laabtay noloshiisii caadiga ahayd.
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.http://www.juventas.cn/news.php?id=711
2.https://www.nejm.org/doi/full/10.1056/NEJMc2403743
Waqtiga boostada: Noofambar-08-2024