I-satri-cel (CT041) ifakiwe njengeyeza lonyango eliphambili yi-National Medical Products Administration.

Ngomhla wama-21 kuFebruwari, ngo-2025, iZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration (i-NMPA) yaseTshayina linike i-Breakthrough Therapy Designation (BTD) ye-Satri-cel（CT041） (imveliso ye-autologous CAR T-cell echasene ne-Claudin18.2), kwi-advanced gastric/esophagogastric junction (G/GEJ) adenocarcinoma ene-Claudin18.2 (CLDN18.2) eyayingazange iphumelele kunyango lwesibini ngaphambili.

Uvavanyo oluqalwe ngumphandi i-CT041-CG4006 (NCT03874897) lwe-satricabtagene autoleucel (“satri-cel”, CT041) (imveliso ye-CAR T-cell echasene neClaudin18.2) oluqalwe ngumphandi lupapashwe kwi-Nature Medicine ngomhla wesi-3 kuJuni 2024.

Olu vavanyo luquke inqanaba lokunyuka kwedosi (n = 15) kunye nenqanaba lokwandiswa kwedosi kwii-cohorts ezine ezahlukeneyo (inani lilonke n = 83): i-cohort 1, i-satri-cel monotherapy kwizigulane ezingama-61 ezine-chemotherapy-refractory gastrointestinal cancers eqhelekileyo; i-cohort 2, i-satri-cel kunye nonyango lwe-anti-PD-1 kwizigulane ezili-15 ezine-chemotherapy-refractory gastrointestinal cancers eqhelekileyo; i-cohort 3, i-satri-cel njengonyango olulandelelanayo emva konyango lokuqala kwizigulane ezihlanu ezine-gastrointestinal cancers; kunye ne-cohort 4, i-satri-cel monotherapy kwizigulane ezibini ezine-anti-CLDN18.2 monoclonal antibody-refractory gastric cancer. Isiphelo esiphambili yayikukhuseleko; isiphelo sesibini sasiquka ukusebenza kakuhle, i-pharmacokinetics kunye ne-immunogenicity. Izigulane ezingama-98 zizonke zafumana i-satri-cel infusion, apho ezingama-89 zanikwa i-2.5 × 108, ezintandathu zine-3.75 × 108 kunye nezintathu ezine-5.0 × 108 CAR T cells. Ulandelelwano oluphakathi beluziinyanga ezingama-32.4 (95% isithuba sokuzithemba (CI): 27.3, 36.5) ukususela ekuphelelweni yintsholongwane. Akukho zityhefu zithintela idosi, ukufa okunxulumene nonyango okanye isifo se-immune effector cell-associated neurotoxicity syndrome esibikiweyo. I-Cytokine release syndrome yenzekile kwi-96.9% yezigulane, zonke zihlelwe njengebanga loku-1-2. Ukulimala kwesisu kuchongiwe kwizigulane ezisibhozo (8.2%). Izinga lokuphendula lilonke kunye nezinga lokulawula isifo kuzo zonke izigulane ezingama-98 yayingama-38.8% kunye nama-91.8%, ngokwahlukeneyo, kwaye ukusinda okuphakathi okungenankqubela phambili kunye nokusinda ngokubanzi yayiziinyanga ezi-4.4 (95% CI: 3.7, 6.6) kunye neenyanga ezi-8.8 (95% CI: 7.1, 10.2), ngokwahlukeneyo. I-Satri-cel ibonisa amandla okunyanga kunye neprofayili yokhuseleko elawulekayo kwizigulane ezine-CLDN18.2-positive advanced gastrointestinal cancer.

Malunga neSatri-cel

I-Satri-cel yimveliso ye-CAR T-cell ekhethiweyo echasene neproteni yeClaudin18.2 enokuba yeyona iphambili kwihlabathi liphela. I-Satri-cel ijolise kunyango lwee-Claudin18.2 positive solid tumors ezijolise kakhulu kumhlaza wesisu/umhlaza we-gastroesophageal junction (GC/GEJ) kunye nomhlaza we-pancreatic (PC). Uvavanyo oluqhubekayo luquka uvavanyo oluqalwe ngabaphenyi (CT041-CG4006, NCT03874897), uvavanyo lweklinikhi oluqinisekisayo lweSigaba sesiBini se-GC/GEJ ephucukileyo eTshayina (CT041-ST-01, NCT04581473), uvavanyo lweklinikhi lweSigaba soku-1 lonyango oluncedisayo lwe-PC eTshayina (CT041-ST-05, NCT05911217), kunye novavanyo lweklinikhi lweSigaba soku-1b/2 lwe-advanced gastric okanye pancreatic adenocarcinoma eMntla Melika (CT041-ST-02, NCT04404595). I-Satri-cel yanikwa i-Regenerative Medicine Advanced Therapy (RMAT) yi-US FDA yokunyanga i-GC/GEJ ephucukileyo ene-Claudin18.2-positive tumors ngoJanuwari 2022 kwaye yanikwa i-PRIME ukufaneleka yi-EMA yokunyanga umhlaza wesisu ophucukileyo ngoNovemba 2021. I-Satri-cel yafumana i-Orphan Drug kwi-US FDA ngo-2020 yokunyanga i-GC/GEJ kunye ne-Orphan Medicinal Product evela kwi-EMA ngo-2021 yokunyanga umhlaza wesisu ophucukileyo.

Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.

Inombolo yefowuni: 4008803716

Email：myimmnet@163.com

Iireferensi

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

2.Iiseli ze-CAR T zeClaudin18.2 ezithile kwiimhlaza zesisu: iziphumo zokugqibela zovavanyo lwesigaba soku-1 | Unyango lweNdalo

3.Ikhaya | I-CARsgen