Mu Ogasiti 2025, Center for Drug Evaluation (CDE) ya National Medical Products Administration (NMPA) idapereka mwalamulo kuti Ina-cel, njira yatsopano yothandizira maselo a CAR-T yotsogozedwa ndi CD19, yopangidwa yokha ndi Juventas, kuti ichiritse odwala omwe ali ndi B-cell acute lymphoblastic leukemia (r/r B-ALL) omwe abwereranso m'thupi kapena omwe asiya kugwira ntchito.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
Nambala ya Foni: 4008803716
Chizindikiro cha WeChat: 17801183037
Email：myimmnet@163.com
Inaticabtagene autoleucel (Inati-cel) ndi mankhwala a CD19-specific chimeric antigen receptor (CAR) T-cell, omwe ali ndi CD19 scFv yochokera ku clone HI19α ndi 4-1BB/CD3-ζ costimulatory domain, yomwe idavomerezedwa ku China kwa odwala akuluakulu omwe ali ndi B-acute lymphoblastic leukemia (r/r B-ALL) yobwereranso kapena yokana (r/r B-ALL) mu Novembala 2023.
TheMsonkhano Wapachaka wa ASCO wa 2025 lipoti Kafukufuku wa zinthu zenizeni (NCT06450067) wokhudza malo ambiri, wosalowererapo (NCT06450067) kuti ayese Inati-cel kwa odwala akuluakulu a B-ALL. Pakati pa Novembala 20, 2023, ndi Novembala 13, 2024, odwala 62 adalandira Inati-cel ndipo anayesedwa. Zaka zapakati zinali zaka 37.5 (zaka 14-76), ndipo odwala 13 anali ndi zaka ≥60. Pakuwunika, milandu 16 inabwereranso pambuyo poika maselo oyambira a hematopoietic (HSCT), milandu 4 inali yolimba kwambiri, ndipo oposa 70% ya odwala anali ndi vuto lalikulu la majini. Mlingo wapakati wa kulowetsedwa unali 0.60 (zaka 0.46-0.9) ×10Maselo amoyo a 8CAR-T.
Zotsatira: Deta yochokera pa Disembala 30, 2024, yokhala ndi zotsatira zapakati pa miyezi 3.8 (kuyambira: miyezi 0.5–12.4), 89.5% adapeza MRD-negative ORR pambuyo pa Inati-cel mwa odwala a r/r, kuphatikiza 31 omwe anali ndi CR ndi 3 omwe anali ndi CRi (tebulo 1). Odwala asanu ndi anayi omwe anali ndi MRD-positive panthawi yoyezetsa, chiŵerengero cha MRD-negativity chinafika 100% pambuyo pa Inati-cel. Pambuyo pa Inati-cel, odwala 26 adapeza zotsatira za MRD pogwiritsa ntchito q-PCR, ndipo 92.3% adapeza zotsatira zoyipa. Atapeza CR/CRi, odwala 4 pambuyo pake adapatsidwa allo-HSCT mu relieval. Apakati a DOR, OS ndi RFS sanafikidwe ndi odwala komanso popanda kuwaletsa pa allo-HSCT yotsatira. Pakati pa odwala omwe adayesedwa, chiŵerengero cha RFS ndi DOR cha chaka chimodzi chinali 76.2% ndi 74.1%, motsatana. Odwala asanu ndi awiri adabwereranso m'thupi, kuphatikizapo kubwereranso m'thupi kwa CD19+ katatu, kubwereranso m'thupi kwa CD19 kawiri, ndi awiri omwe sanadziwike bwino momwe CD19 ilili. Ndikofunikira kudziwa kuti pa milandu 6 ya matenda akunja kwa medullary, milandu 4 idagwira ntchito, koma milandu iwiri idabwereranso mkati mwa miyezi itatu kuchokera pamene Inati-cel idalowa. Odwala onse omwe adalandira Inati-cel adalowetsedwa anali amoyo, kupatula imfa imodzi chifukwa cha kupita patsogolo kwa matenda. Zochitika zoyipa kwambiri (AEs) zomwe zinali zofunika kwambiri zinali cytokine release syndrome (CRS) ndi immune effector cell-associated neurotoxicity syndrome (ICANS). 51 peresenti ya odwala adadwala CRS, koma CRS ndi ICANS za giredi 3 kapena kupitirira apo zidachitika mwa 3.2% ndi 1.6% ya odwala, motsatana; odwala onse akuchira popanda zotsatira zake, palibe imfa zokhudzana ndi AE.
Kugwiritsa ntchito Inati-cel m'njira yeniyeni kukuwonetsa kuti pali MRD-negative ORR yambiri mwa akuluakulu a B-ALL. Chitetezo chinali chotheka, ndipo panalibe kuchuluka kwa CRS ndi ICANS m'njira yeniyeni. Deta yotsatizana yayitali idzaperekedwa.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
Nambala ya Foni: 4008803716
Chizindikiro cha WeChat: 17801183037
Email：myimmnet@163.com
Nthawi yotumizira: Ogasiti-26-2025