I ʻAukake 2025, ua hāʻawi kūhelu ke Center for Drug Evaluation (CDE) o ka National Medical Products Administration (NMPA) i ka Breakthrough Therapy Designation iā Ina-cel, kahi lāʻau lapaʻau CAR-T cell CD19-directed hou i hoʻomohala kūʻokoʻa ʻia e Juventas, no ka mālama ʻana i nā maʻi pediatric me ka relapsed a refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
Helu Kelepona：4008803716
ʻIkepili WeChat: 17801183037
Email：myimmnet@163.com
ʻO Inaticabtagene autoleucel (Inati-cel) kahi huahana T-cell chimeric antigen receptor (CAR) kikoʻī CD19, e hōʻike ana i kahi CD19 scFv i loaʻa mai ka clone HI19α a me kahi kikowaena costimulatory 4-1BB/CD3-ζ, i ʻāpono ʻia ma Kina no nā poʻe maʻi makua me ka relapsed a refractory B-acute lymphoblastic leukemia (r/r B-ALL) i Nowemapa 2023.
ʻO kaHālāwai Makahiki ASCO 2025 hōʻike ke aʻo honua maoli multi-center, non-interventional (NCT06450067) e loiloi iā Inati-cel no nā poʻe maʻi B-ALL makua. Ma waena o Nowemapa 20, 2023, a me Nowemapa 13, 2024, ua loaʻa iā 62 mau maʻi ʻo Inati-cel a hiki ke loiloi ʻia. ʻO ka makahiki waena he 37.5 (pae, 14-76) mau makahiki, me 13 mau maʻi i piha i ka ≥60 mau makahiki. I ka nānā ʻana, ua hoʻi hou ʻia he 16 mau hihia ma hope o ka hoʻoili ʻana o nā cell stem hematopoietic (HSCT), he 4 mau hihia he refractory mua, a ʻoi aku ma mua o 70% o nā maʻi i lawe i ka maʻi genetic kiʻekiʻe. ʻO ka nui o ka infusion waena he 0.60 (pae: 0.46-0.9) ×10Nā pūnaewele ola 8CAR-T.
Nā Hualoaʻa: ʻO ka ʻikepili e like me Dekemaba 30, 2024, me ka nānā ʻana ma waena o 3.8 mau mahina (pae: 0.5–12.4 mau mahina), 89.5% i loaʻa iā MRD-negative ORR ma hope o Inati-cel i nā maʻi r/r, me 31 me CR a me 3 me CRi (papa1). ʻEiwa mau maʻi me MRD-positive i ka nānā ʻana, ua hiki ka helu MRD-negativity i 100% ma hope o Inati-cel. Ma hope o Inati-cel, ua ʻike ʻia nā hopena MRD he 26 mau maʻi e q-PCR, a ua loaʻa iā 92.3% nā hopena maikaʻi ʻole. Ma hope o ka loaʻa ʻana o CR/CRi, ua hana ʻia he 4 mau maʻi i ka allo-HSCT i ka wā hoʻomaha. ʻAʻole i hiki ʻia ka DOR waena, OS a me RFS me ka ʻole o ka censoring ʻana i nā maʻi ma hope o allo-HSCT. Ma waena o nā maʻi i loiloi ʻia, ʻo nā helu RFS a me DOR 1 makahiki he 76.2% a me 74.1%, kēlā me kēia. ʻEhiku mau maʻi i loaʻa i nā relapses, me 3 CD19+ relapses, 2 CD19- relapses, a me 2 me ke kūlana CD19 maopopo ʻole. He mea kūpono ke hoʻomaopopo ʻana i loko o 6 mau hihia o ka maʻi extramedullary, 4 mau hihia i kūleʻa, akā 2 mau hihia i relapsed i loko o 3 mau mahina ma hope o Inati-cel. Ua ola nā maʻi a pau i loaʻa i ka infusion Inati-cel, koe wale nō hoʻokahi make mai ka holomua o ka maʻi. ʻO nā hanana ʻino maʻamau (AEs) o ka hoihoi kūikawā ʻo ia ka cytokine release syndrome (CRS) a me ka immune effector cell-associated neurotoxicity syndrome (ICANS). Kanalimakumamākahi pakeneka o nā maʻi i loaʻa iā CRS, akā ʻo ka CRS papa 3 a ʻoi aku paha a me ICANS i loaʻa wale i 3.2% a me 1.6% o nā maʻi, kēlā me kēia; nā maʻi a pau e hoʻōla ana me ka ʻole o ka hopena, ʻaʻohe make e pili ana i ka AE.
ʻO ka hoʻohana maoli ʻana o Inati-cel i ke ao maoli e hōʻike ana i kahi ORR MRD-negative kiʻekiʻe i ka pākeke B-ALL. Ua hiki ke hoʻokele ʻia ke ʻano palekana, me ka haʻahaʻa o ka helu ≥3 CRS a me ICANS i ka hoʻonohonoho honua maoli. E hōʻike ʻia nā ʻikepili hahai lōʻihi.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
Helu Kelepona：4008803716
ʻIkepili WeChat: 17801183037
Email：myimmnet@163.com
Ka manawa hoʻouna: ʻAukake-26-2025