Ma Pepeluali 21, 2025, ua hāʻawi ke Center for Drug Evaluation (CDE) o ka National Medical Products Administration (NMPA) o Kina i ka Breakthrough Therapy Designation (BTD) no Satri-cel（CT041）(he moho huahana CAR T-cell autologous e kūʻē iā Claudin18.2), no ka adenocarcinoma gastric/esophagogastric junction (G/GEJ) holomua me ka hōʻike maikaʻi o Claudin18.2 (CLDN18.2) i hāʻule mua ma ka liʻiliʻi o ka lāʻau lapaʻau lua.
Ua paʻi ʻia ka hoʻokolohua i hoʻomaka ʻia e ka mea noiʻi CT041-CG4006 (NCT03874897) o satricabtagene autoleucel (“satri-cel”, CT041) (he moho huahana CAR T-cell autologous e kūʻē iā Claudin18.2) ma Nature Medicine ma Iune 3, 2024.
Ua komo kēia hoʻokolohua i kahi pae hoʻonui lāʻau (n = 15) a me kahi pae hoʻonui lāʻau i ʻehā mau cohorts like ʻole (huina n = 83): cohort 1, satri-cel monotherapy i 61 mau maʻi me nā maʻi ʻaʻai gastrointestinal maʻamau chemotherapy-refractory; cohort 2, satri-cel me ka anti-PD-1 therapy i 15 mau maʻi me nā maʻi ʻaʻai gastrointestinal maʻamau chemotherapy-refractory; cohort 3, satri-cel ma ke ʻano he lāʻau lapaʻau ma hope o ka lāʻau lapaʻau laina mua i ʻelima mau maʻi me nā maʻi ʻaʻai gastrointestinal; a me cohort 4, satri-cel monotherapy i ʻelua mau maʻi me ka anti-CLDN18.2 monoclonal antibody-refractory gastric cancer. ʻO ke kumu hope mua ka palekana; ʻo nā kumu hope lua i komo pū me ka pono, pharmacokinetics a me ka immunogenicity. He 98 mau maʻi i loaʻa i ka infusion satri-cel, i waena o lākou he 89 i dosed me 2.5 × 108, ʻeono me 3.75 × 108 a ʻekolu me 5.0 × 108 CAR T cells. ʻO ka hahai ʻana ma waena he 32.4 mau mahina (95% hilinaʻi waena (CI): 27.3, 36.5) mai ka apheresis. ʻAʻohe mea ʻawaʻawa e kaupalena ana i ka lāʻau, nā make e pili ana i ka lāʻau lapaʻau a i ʻole ka maʻi neurotoxicity e pili ana i nā cell effector immune i hōʻike ʻia. Ua loaʻa ka maʻi hoʻokuʻu cytokine i 96.9% o nā maʻi, i hoʻokaʻawale ʻia he papa 1-2. Ua ʻike ʻia nā ʻeha mucosal gastric i ʻewalu (8.2%) mau maʻi. ʻO ka helu pane holoʻokoʻa a me ka helu kaohi maʻi i nā maʻi 98 āpau he 38.8% a me 91.8%, kēlā me kēia, a ʻo ke ola median progression-free a me ke ola holoʻokoʻa he 4.4 mau mahina (95% CI: 3.7, 6.6) a me 8.8 mau mahina (95% CI: 7.1, 10.2), kēlā me kēia. Hōʻike ʻo Satri-cel i ka hiki ke therapeutic me kahi ʻaoʻao palekana hiki ke hoʻokele ʻia i nā maʻi me ka maʻi ʻōpū holomua CLDN18.2-positive.
E pili ana iā Satri-cel
He moho huahana CAR T-cell autologous ʻo Satri-cel e kūʻē i ka protein Claudin18.2 nona ka hiki ke lilo i mua ma ka papa honua. Hoʻolālā ʻo Satri-cel i ka mālama ʻana i nā puʻupuʻu paʻa Claudin18.2 maikaʻi me ka nānā nui ʻana i ka maʻi ʻaʻai gastric/gastroesophageal junction cancer (GC/GEJ) a me ka maʻi ʻaʻai pancreatic (PC). ʻO nā hoʻokolohua e hoʻomau nei e komo pū me nā hoʻokolohua i hoʻomaka ʻia e ka mea noiʻi (CT041-CG4006, NCT03874897), kahi hoʻokolohua lapaʻau Phase II hōʻoia no ka GC/GEJ holomua ma Kina (CT041-ST-01, NCT04581473), kahi hoʻokolohua lapaʻau Phase I no ka lāʻau lapaʻau adjuvant PC ma Kina (CT041-ST-05, NCT05911217), a me kahi hoʻokolohua lapaʻau Phase 1b/2 no ka adenocarcinoma gastric a pancreatic holomua ma ʻAmelika ʻĀkau (CT041-ST-02, NCT04404595). Ua hāʻawi ʻia ʻo Satri-cel i ka hoʻohanohano ʻana o Regenerative Medicine Advanced Therapy (RMAT) e ka US FDA no ka mālama ʻana i ka GC/GEJ holomua me nā puʻupuʻu Claudin18.2-positive i Ianuali 2022 a ua hāʻawi ʻia iā ia ke kūpono PRIME e ka EMA no ka mālama ʻana i ka maʻi ʻaʻai ʻōpū holomua i Nowemapa 2021. Ua loaʻa iā Satri-cel ka hoʻohanohano ʻana o Orphan Drug mai ka US FDA i ka makahiki 2020 no ka mālama ʻana i ka GC/GEJ a me ka hoʻohanohano ʻana o Orphan Medicinal Product mai ka EMA i ka makahiki 2021 no ka mālama ʻana i ka maʻi ʻaʻai ʻōpū holomua.
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.
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Nā Kuhikuhi
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
Ka manawa hoʻouna: Pepeluali-27-2025