satri-cel (CT041) tau raug suav nrog ua ib qho tshuaj kho mob tshiab los ntawm National Medical Products Administration

Thaum Lub Ob Hlis 21, 2025, Lub Chaw Saib Xyuas Kev Tshuaj Xyuas Tshuaj (CDE) ntawm Tuam Tshoj Lub Chaw Tswj Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau tso cai rau Breakthrough Therapy Designation (BTD) rau Satri-cel (CT041) (tus neeg sib tw khoom CAR T-cell autologous tawm tsam Claudin18.2), rau kev sib txuas ntawm lub plab zom mov / esophagogastric (G / GEJ) adenocarcinoma nrog kev qhia zoo ntawm Claudin18.2 (CLDN18.2) uas yav dhau los tsis ua tiav tsawg kawg yog kab thib ob kev kho mob.

Cov kev sim uas tus kws tshawb nrhiav pib CT041-CG4006 (NCT03874897) ntawm satricabtagene autoleucel (“satri-cel”, CT041) (ib qho khoom lag luam CAR T-cell autologous tawm tsam Claudin18.2) tau luam tawm hauv Nature Medicine rau lub Rau Hli 3, 2024.

Qhov kev sim no suav nrog theem kev nce koob tshuaj (n = 15) thiab theem kev nthuav koob tshuaj hauv plaub pawg sib txawv (tag nrho n = 83): pawg 1, satri-cel monotherapy hauv 61 tus neeg mob uas muaj tus qauv chemotherapy-refractory gastrointestinal cancer; pawg 2, satri-cel ntxiv rau kev kho mob anti-PD-1 hauv 15 tus neeg mob uas muaj tus qauv chemotherapy-refractory gastrointestinal cancer; pawg 3, satri-cel ua kev kho mob tom qab thawj kab kev kho mob hauv tsib tus neeg mob uas muaj mob qog noj ntshav gastrointestinal; thiab pawg 4, satri-cel monotherapy hauv ob tus neeg mob uas muaj anti-CLDN18.2 monoclonal antibody-refractory gastric cancer. Lub ntsiab lus tseem ceeb yog kev nyab xeeb; qhov kawg thib ob suav nrog kev ua tau zoo, pharmacokinetics thiab immunogenicity. Tag nrho ntawm 98 tus neeg mob tau txais satri-cel infusion, ntawm cov uas 89 tau koob tshuaj nrog 2.5 × 108, rau nrog 3.75 × 108 thiab peb nrog 5.0 × 108 CAR T hlwb. Qhov nruab nrab ntawm kev saib xyuas yog 32.4 lub hlis (95% kev ntseeg siab (CI): 27.3, 36.5) txij li thaum apheresis. Tsis muaj kev tshuaj lom uas txwv tsis pub noj tshuaj, kev tuag ntsig txog kev kho mob lossis kev mob hlwb cuam tshuam nrog lub cev tiv thaiv kab mob tau tshaj tawm. Cytokine tso tawm syndrome tshwm sim hauv 96.9% ntawm cov neeg mob, txhua tus raug cais ua qib 1-2. Kev raug mob ntawm lub plab hnyuv tau pom hauv yim (8.2%) cov neeg mob. Tag nrho cov lus teb thiab kev tswj kab mob hauv tag nrho 98 tus neeg mob yog 38.8% thiab 91.8%, raws li, thiab qhov nruab nrab ntawm kev ciaj sia tsis muaj kev nce qib thiab tag nrho kev ciaj sia yog 4.4 lub hlis (95% CI: 3.7, 6.6) thiab 8.8 lub hlis (95% CI: 7.1, 10.2), raws li. Satri-cel qhia txog kev kho mob nrog cov ntaub ntawv kev nyab xeeb uas tswj tau hauv cov neeg mob uas muaj mob qog noj ntshav CLDN18.2-zoo.

Txog Satri-cel

Satri-cel yog ib yam khoom siv CAR T-cell uas siv los kho cov kab mob Claudin18.2 uas muaj peev xwm ua tau thawj zaug hauv ntiaj teb. Satri-cel tsom mus rau kev kho cov qog nqaij hlav Claudin18.2 uas muaj cov qog nqaij hlav zoo nrog rau kev tsom mus rau mob qog nqaij hlav hauv plab/mob qog nqaij hlav hauv plab (GC/GEJ) thiab mob qog nqaij hlav hauv plab (PC). Cov kev sim uas tseem tab tom ua suav nrog kev sim uas cov kws tshawb nrhiav pib (CT041-CG4006, NCT03874897), kev sim tshuaj theem II rau GC/GEJ siab heev hauv Suav teb (CT041-ST-01, NCT04581473), kev sim tshuaj theem I rau PC adjuvant therapy hauv Suav teb (CT041-ST-05, NCT05911217), thiab kev sim tshuaj theem 1b/2 rau mob qog nqaij hlav hauv plab lossis pancreatic adenocarcinoma siab heev hauv North America (CT041-ST-02, NCT04404595). Satri-cel tau txais kev tso cai Regenerative Medicine Advanced Therapy (RMAT) los ntawm US FDA rau kev kho mob GC/GEJ siab heev nrog Claudin18.2-positive qog thaum Lub Ib Hlis 2022 thiab tau txais kev tsim nyog PRIME los ntawm EMA rau kev kho mob qog noj ntshav hauv plab thaum Lub Kaum Ib Hlis 2021. Satri-cel tau txais kev tso cai Orphan Drug los ntawm US FDA hauv xyoo 2020 rau kev kho mob GC/GEJ thiab Orphan Medicinal Product los ntawm EMA hauv xyoo 2021 rau kev kho mob qog noj ntshav hauv plab.

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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Cov ntaub ntawv siv los ua piv txwv

1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

2.Claudin18.2-specific CAR T cells hauv cov mob qog noj ntshav hauv plab hnyuv: theem 1 qhov kawg ntawm kev sim | Nature Medicine

3.Tsev | CARsgen