I-satri-cel (CT041) ifakiwe njengomuthi wokwelapha ophumelelayo yi-National Medical Products Administration.

Ngomhlaka-21 kuNhlolanja 2025, i-Center for Drug Evaluation (CDE) ye-National Medical Products Administration (NMPA) yaseShayina inikeze i-Breakthrough Therapy Designation (BTD) ye-Satri-cel（CT041） (umkhiqizo we-autologous CAR T-cell omelene ne-Claudin18.2), ye-advanced gastric/esophagogastric junction (G/GEJ) adenocarcinoma ene-Claudin18.2 (CLDN18.2) eye yahluleka okungenani ukwelashwa komugqa wesibili ngaphambilini.

Isilingo esiqalwe ngumphenyi i-CT041-CG4006 (NCT03874897) se-satricabtagene autoleucel (“satri-cel”, CT041) (umkhiqizo we-CAR T-cell omelene noClaudin18.2) sishicilelwe ku-Nature Medicine ngomhlaka-3 Juni 2024.

Lolu cwaningo luhlanganise isigaba sokukhuphuka komthamo (n = 15) kanye nesigaba sokwanda komthamo kuma-cohort amane ahlukene (isamba n = 83): i-cohort 1, i-satri-cel monotherapy ezigulini ezingu-61 ezinomdlavuza wesisu ojwayelekile we-chemotherapy-refractory; i-cohort 2, i-satri-cel kanye nokwelashwa kwe-anti-PD-1 ezigulini ezingu-15 ezinomdlavuza wesisu ojwayelekile we-chemotherapy-refractory; i-cohort 3, i-satri-cel njengokwelashwa okulandelanayo ngemva kokwelashwa kokuqala ezigulini ezinhlanu ezinomdlavuza wesisu; kanye ne-cohort 4, i-satri-cel monotherapy ezigulini ezimbili ezinomdlavuza wesisu ophikisana ne-CLDN18.2 monoclonal antibody-refractory. Isiphetho esiyinhloko kwakuwukuphepha; amaphuzu okugcina esibili ahlanganisa ukusebenza kahle, i-pharmacokinetics kanye ne-immunogenicity. Iziguli ezingu-98 sezizonke zathola ukufakwa kwe-satri-cel, phakathi kwazo ezingu-89 zanikezwa i-2.5 × 108, eziyisithupha ezine-3.75 × 108 kanye ezintathu ezine-5.0 × 108 CAR T cells. Ukulandelela okumaphakathi kwaba yizinyanga ezingu-32.4 (isikhawu sokuzethemba esingu-95% (CI): 27.3, 36.5) kusukela ekuphelelweni yithemba. Akukho ubuthi obukhawulela umthamo, ukufa okuhlobene nokwelashwa noma i-immune effector cell-associated neurotoxicity syndrome okubikiwe. I-Cytokine release syndrome yenzeka ku-96.9% weziguli, zonke zihlukaniswe njengebanga 1-2. Ukulimala kwesisu kwatholakala ezigulini eziyisishiyagalombili (8.2%). Izinga lokuphendula lilonke kanye nezinga lokulawula izifo kuzo zonke iziguli ezingu-98 kwakungu-38.8% kanye no-91.8%, ngokulandelana, kanti ukusinda okumaphakathi okungenalo inqubekela phambili kanye nokusinda okuphelele kwaba yizinyanga ezingu-4.4 (95% CI: 3.7, 6.6) kanye nezinyanga ezingu-8.8 (95% CI: 7.1, 10.2), ngokulandelana. I-Satri-cel ikhombisa amandla okwelapha ngephrofayili yokuphepha elawulekayo ezigulini ezine-CLDN18.2-positive advanced gastrointestinal cancer.

Mayelana ne-Satri-cel

I-Satri-cel iyi-autologous CAR T-cell product preferred against the protein Claudin18.2 enekhono lokuba yi-first-class emhlabeni jikelele. I-Satri-cel ihlose ukwelashwa kwama-solid tumors e-Claudin18.2 positive, okugxilwe kakhulu kumdlavuza wesisu/umdlavuza we-gastroesophageal junction (GC/GEJ) kanye nomdlavuza we-pancreatic (PC). Izivivinyo eziqhubekayo zifaka phakathi izivivinyo eziqalwe ngumcwaningi (CT041-CG4006, NCT03874897), isivivinyo somtholampilo seSigaba II esiqinisekisayo se-GC/GEJ ethuthukisiwe eShayina (CT041-ST-01, NCT04581473), isivivinyo somtholampilo seSigaba I sokwelashwa kwe-PC adjuvant eShayina (CT041-ST-05, NCT05911217), kanye nesivivinyo somtholampilo seSigaba 1b/2 se-advanced gastric adenocarcinoma noma i-pancreatic adenocarcinoma eNyakatho Melika (CT041-ST-02, NCT04404595). I-Satri-cel yanikezwa isikhundla se-Regenerative Medicine Advanced Therapy (RMAT) yi-US FDA sokwelapha i-GC/GEJ ethuthukisiwe enezimila ze-Claudin18.2 ngoJanuwari 2022 futhi yanikezwa ilungelo le-PRIME yi-EMA lokwelapha umdlavuza wesisu othuthukisiwe ngoNovemba 2021. I-Satri-cel yathola isikhundla se-Orphan Drug evela kwi-US FDA ngo-2020 sokwelapha i-GC/GEJ kanye nesikhundla se-Orphan Medicinal Product esivela kwi-EMA ngo-2021 sokwelapha umdlavuza wesisu othuthukisiwe.

Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.

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Izinkomba

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

2.Amaseli e-CAR T e-Claudin angu-18.2 athile kumdlavuza wesisu: imiphumela yokugcina yesivivinyo sesigaba 1 | Imithi Yemvelo

3.Ikhaya | I-CARsgen