A ranar 21 ga Fabrairu, 2025, Cibiyar Kimanta Magunguna (CDE) ta Hukumar Kula da Kayayyakin Lafiya ta Kasa (NMPA) ta ba da izinin a ba da Nadin Breakthrough Therapy (BTD) don Satri-cel(CT041) (wani samfurin ƙwayoyin T-cell na CAR da ke da alaƙa da Claudin18.2) don ciwon daji na ciki/esophagogastric junction (G/GEJ) tare da bayyanar Claudin18.2 (CLDN18.2) wanda a baya ya gaza yin magani na biyu.
An buga gwajin da mai binciken ya fara yi wa satriccabtagene autoleucel ("satri-cel", CT041) (wanda aka yi wa gwajin kwayoyin halitta na CAR T-cell da Claudin18.2) a cikin Nature Medicine a ranar 3 ga Yuni, 2024.
Wannan gwajin ya haɗa da matakin ƙaruwar allurai (n = 15) da matakin faɗaɗa allurai a cikin ƙungiyoyi huɗu daban-daban (jimillar n = 83): ƙungiyar 1, maganin satri-cel monotherapy a cikin marasa lafiya 61 da ke fama da cutar kansar ciki ta chemotherapy-refractory; ƙungiyar 2, maganin satri-cel da maganin anti-PD-1 a cikin marasa lafiya 15 da ke fama da cutar kansar ciki ta chemotherapy-refractory; ƙungiyar 3, maganin satri-cel a matsayin magani mai bibiyar bayan maganin farko a cikin marasa lafiya biyar da ke fama da cutar kansar ciki; da ƙungiyar 4, maganin satri-cel monotherapy a cikin marasa lafiya biyu da ke fama da cutar kansar ciki ta anti-CLDN18.2 monoclonal antibody-refractory. Babban maƙasudin ƙarshe shine aminci; ƙarshen ƙarshe ya haɗa da inganci, pharmacokinetics da kuma immunogenicity. Jimillar marasa lafiya 98 sun sami jiko na satri-cel, daga cikinsu an ba wa 89 allurai 2.5 × 108, shida tare da 3.75 × 108 da uku tare da ƙwayoyin CAR T 5.0 × 108. Matsakaicin bin diddigin ya kasance watanni 32.4 (95% confidence tazara (CI): 27.3, 36.5) tun lokacin da aka gano cutar. Ba a bayar da rahoton wani guba da ke iyakance yawan shan magani ba, mutuwar da ke da alaƙa da magani ko kuma cutar neurotoxicity da ke da alaƙa da ƙwayoyin cuta. An gano cutar sakin cytokine a cikin kashi 96.9% na marasa lafiya, duk an rarraba su a matsayin aji 1-2. An gano raunin mucosal na ciki a cikin marasa lafiya takwas (8.2%). Jimillar martanin da ƙimar sarrafa cututtuka a cikin dukkan marasa lafiya 98 sun kasance 38.8% da 91.8%, bi da bi, kuma matsakaicin rayuwa ba tare da ci gaba ba da rayuwa gabaɗaya sun kasance watanni 4.4 (95% CI: 3.7, 6.6) da watanni 8.8 (95% CI: 7.1, 10.2), bi da bi. Satri-cel yana nuna yuwuwar warkewa tare da bayanin aminci mai sarrafawa a cikin marasa lafiya da ke da cutar kansar ciki mai ci gaba ta CLDN18.2-positive.
Game da Satri-cel
Satri-cel wani samfurin ƙwayoyin CAR T ne da ke da ikon zama na farko a duniya. Satri-cel yana nufin maganin ciwon daji mai ƙarfi na Claudin18.2 tare da mayar da hankali kan ciwon daji na ciki/na ciki (GC/GEJ) da ciwon daji na pancreas (PC). Gwaje-gwajen da ake ci gaba da yi sun haɗa da gwaje-gwajen da masu bincike suka fara (CT041-CG4006, NCT03874897), gwajin asibiti na Phase II da ke tabbatar da ingancin GC/GEJ a China (CT041-ST-01, NCT04581473), gwajin asibiti na Phase I don maganin PC adjuvant a China (CT041-ST-05, NCT05911217), da gwajin asibiti na Phase 1b/2 don ciwon daji na ciki ko na pancreas a Arewacin Amurka (CT041-ST-02, NCT04404595). Hukumar Kula da Cututtuka ta Amurka (FDA) ta bai wa Satri-cel takardar shaidar Regenerative Medicine Advanced Therapy (RMAT) don maganin ciwon daji mai tsanani na GC/GEJ tare da Claudin18.2-positive a watan Janairun 2022, kuma EMA ta ba shi takardar shaidar PRIME don maganin ciwon daji mai tsanani a watan Nuwamban 2021. Satri-cel ta sami takardar shaidar Orphan Drug daga Hukumar Kula da Cututtuka ta Amurka (FDA) a shekarar 2020 don maganin GC/GEJ da kuma takardar shaidar Orphan Medicinal Product daga EMA a shekarar 2021 don maganin ciwon daji mai tsanani.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Nassoshi
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
Lokacin Saƙo: Fabrairu-27-2025