Thaum Lub Rau Hli 26, 2025, CARsgen tshaj tawm tias Lub Chaw Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) ntawm Tuam Tshoj tau txais Daim Ntawv Thov Tshuaj Tshiab (NDA) rau satricabtagene autoleucel (“satri-cel”, CT041) (tus neeg sib tw CAR T-cell autologous tiv thaiv protein Claudin18.2) rau kev kho mob Claudin18.2-zoo advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) hauv cov neeg mob uas tsis tau ua tiav tsawg kawg yog ob kab kev kho mob yav dhau los. Daim ntawv xa NDA feem ntau yog raws li cov txiaj ntsig ntawm kev qhib-daim ntawv lo, ntau lub chaw, randomized tswj kev lees paub theem II kev sim tshuaj (CT041-ST-01, NCT04581473) ua nyob rau hauv Tuam Tshoj. Cov ntaub ntawv tau nthuav tawm hauv The Lancet thiab ntawm 2025 American Society of Clinical Oncology (ASCO) Lub Rooj Sib Tham Txhua Xyoo.
Txog Satri-cel
Satri-cel yog ib yam khoom siv CAR T-cell uas muaj tus kheej tiv thaiv cov protein Claudin18.2 uas muaj peev xwm ua thawj zaug hauv ntiaj teb. Satri-cel tsom mus rau kev kho cov qog nqaij hlav Claudin18.2-positive nrog rau kev tsom mus rau G/GEJA thiab mob qog nqaij hlav pancreatic (PC). Cov kev sim pib suav nrog cov kev sim pib los ntawm tus kws tshawb nrhiav (CT041-CG4006, NCT03874897), kev sim tshuaj theem II rau G/GEJA siab heev hauv Suav teb (CT041-ST-01, NCT04581473), kev sim tshuaj rau PC adjuvant hauv Suav teb (CT041-ST-05, NCT05911217), kev sim tshuaj satri-cel uas tus kws tshawb nrhiav pib siv los ua kev kho mob tom qab kev kho mob adjuvant rau cov neeg mob uas tau phais G/GEJA (CT041-CG4010, NCT06857786), thiab kev sim tshuaj theem 1b/2 rau adenocarcinoma siab heev hauv plab lossis pancreatic hauv North America (CT041-ST-02, NCT04404595).
Satri-cel tau txais kev tshuaj xyuas ua ntej los ntawm Lub Chaw Saib Xyuas Tshuaj (CDE) ntawm Tuam Tshoj NMPA rau kev kho mob Claudin18.2-zoo G/GEJA hauv cov neeg mob uas tsis tau ua tiav tsawg kawg yog ob kab kev kho mob yav dhau los thaum lub Tsib Hlis 2025. Satri-cel tau txais kev tsim kho tshiab los ntawm CDE ntawm Tuam Tshoj NMPA rau kev kho mob Claudin18.2-zoo G/GEJA hauv cov neeg mob uas tsis tau ua tiav tsawg kawg yog ob kab kev kho mob yav dhau los thaum lub Peb Hlis 2025. Satri-cel tau txais kev tsim kho Regenerative Medicine Advanced Therapy los ntawm US FDA rau kev kho mob G/GEJA nrog Claudin18.2-zoo qog thaum Lub Ib Hlis 2022. Satri-cel tau txais kev tsim tshuaj Orphan los ntawm US FDA rau kev kho mob G/GEJA thaum lub Cuaj Hlis 2020.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Qi, Changsong thiab lwm tus. Kev kho mob Claudin-18 isoform 2-specific CAR T-cell (satri-cel) piv rau kev kho mob ntawm tus kws kho mob xaiv rau kev kho mob qog nqaij hlav lossis mob qog nqaij hlav gastro-oesophageal uas tau kho ua ntej (CT041-ST-01): kev sim tshuaj randomized, qhib-daim ntawv lo, theem 2. The Lancet, Ntim 0, Qhov Teeb Meem 0
Lub sijhawm tshaj tawm: Lub Rau Hli-26-2025