Pa February 21, 2025, Center for Drug Evaluation (CDE) ya China's National Medical Products Administration (NMPA) yapereka Breakthrough Therapy Designation (BTD) ya Satri-cel (CT041) (mankhwala a autologous CAR T-cell omwe angagwiritsidwe ntchito motsutsana ndi Claudin18.2), kwa adenocarcinoma yapakhungu ya m'mimba/m'mimba (G/GEJ) yokhala ndi Claudin18.2 (CLDN18.2) yomwe idalephera kale chithandizo chachiwiri.
Mlandu woyambitsidwa ndi ofufuza CT041-CG4006 (NCT03874897) wa satricabtagene autoleucel (“satri-cel”, CT041) (mankhwala a autologous CAR T-cell omwe akutsutsana ndi Claudin18.2) adasindikizidwa mu Nature Medicine pa June 3, 2024.
Kuyesaku kunaphatikizapo gawo lokulitsa mlingo (n = 15) ndi gawo lokulitsa mlingo m'magulu anayi osiyanasiyana (onse n = 83): gulu loyamba, satri-cel monotherapy mwa odwala 61 omwe ali ndi khansa ya m'mimba yodziwika bwino ya chemotherapy; gulu lachiwiri, satri-cel kuphatikiza chithandizo cha anti-PD-1 mwa odwala 15 omwe ali ndi khansa ya m'mimba yodziwika bwino ya chemotherapy; gulu lachitatu, satri-cel ngati chithandizo chotsatira pambuyo pa chithandizo choyamba mwa odwala asanu omwe ali ndi khansa ya m'mimba; ndi gulu lachinayi, satri-cel monotherapy mwa odwala awiri omwe ali ndi khansa ya m'mimba yodziwika bwino ya anti-CLDN18.2. Cholinga chachikulu chinali chitetezo; mapeto achiwiri anali kuphatikiza mphamvu, pharmacokinetics ndi immunogenicity. Odwala onse 98 adalandira satri-cel infusion, omwe 89 adapatsidwa 2.5 × 108, asanu ndi mmodzi ndi 3.75 × 108 ndi atatu ndi maselo a 5.0 × 108 a CAR T. Kutsatira kwapakati kunali miyezi 32.4 (95% nthawi yodzidalira (CI): 27.3, 36.5) kuyambira nthawi yopuma. Palibe poizoni wochepetsa mlingo, imfa zokhudzana ndi chithandizo kapena matenda okhudzana ndi chitetezo cha mthupi omwe amagwirizanitsidwa ndi neurotoxicity omwe adanenedwa. Cytokine release syndrome idachitika mwa odwala 96.9%, onse omwe adagawidwa ngati giredi 1-2. Kuvulala kwa mucosal m'mimba kudapezeka mwa odwala asanu ndi atatu (8.2%). Chiwerengero chonse cha mayankho ndi kuchuluka kwa kuwongolera matenda mwa odwala onse 98 chinali 38.8% ndi 91.8%, motsatana, ndipo apakati opulumuka opanda kupita patsogolo komanso kupulumuka konse anali miyezi 4.4 (95% CI: 3.7, 6.6) ndi miyezi 8.8 (95% CI: 7.1, 10.2), motsatana. Satri-cel ikuwonetsa kuthekera kochiritsira ndi mbiri yotetezeka yoyendetsedwa mwa odwala omwe ali ndi khansa ya m'mimba yotsogola ya CLDN18.2.
About Satri-cel
Satri-cel ndi mankhwala a autologous CAR T-cell omwe amatsutsana ndi puloteni ya Claudin18.2 yomwe ikhoza kukhala yoyamba padziko lonse lapansi. Satri-cel ikufuna kuchiza matenda a Claudin18.2 omwe ali ndi khansa yolimba yomwe imayang'ana kwambiri khansa ya m'mimba/gastroesophageal junction (GC/GEJ) ndi khansa ya kapamba (PC). Mayeso omwe akupitilira akuphatikizapo mayeso oyambitsidwa ndi ofufuza (CT041-CG4006, NCT03874897), mayeso otsimikizira a Phase II a GC/GEJ yotsogola ku China (CT041-ST-01, NCT04581473), mayeso a Phase I a PC adjuvant therapy ku China (CT041-ST-05, NCT05911217), ndi mayeso a Phase 1b/2 a adenocarcinoma yotsogola ya m'mimba kapena kapamba ku North America (CT041-ST-02, NCT04404595). Satri-cel adapatsidwa dzina la Regenerative Medicine Advanced Therapy (RMAT) ndi US FDA kuti azitha kuchiza matenda a GC/GEJ omwe ali ndi zotupa za Claudin18.2 mu Januwale 2022 ndipo EMA idapatsidwa dzina la PRIME kuti azitha kuchiza khansa ya m'mimba yoopsa mu Novembala 2021. Satri-cel adalandira dzina la Orphan Drug kuchokera ku US FDA mu 2020 kuti azitha kuchiza GC/GEJ ndi Orphan Medicinal Product kuchokera ku EMA mu 2021 kuti azitha kuchiza khansa ya m'mimba yoopsa.
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.
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Zolemba
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
Nthawi yotumizira: Feb-27-2025