Na Febụwarị 21, 2025, Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA) enyela Breakthrough Therapy Nomination (BTD) maka Satri-cel(CT041) (onye nwere ike ịlụso Claudin18.2 ọgụ) maka adenocarcinoma afọ/esophagogastric junction (G/GEJ) nke nwere mmetụta dị mma nke Claudin18.2 (CLDN18.2) nke dara na mbụ ma ọ dịkarịa ala ọgwụgwọ nke abụọ.
E bipụtala ikpe CT041-CG4006 (NCT03874897) nke satriccabtagene autoleucel ("satri-cel", CT041) (onye na-achọ ngwaahịa CAR T-cell onwe ya megide Claudin18.2) nke onye nyocha malitere na Nature Medicine na June 3, 2024.
Nnwale a gụnyere usoro ọgwụgwọ dose-excalation (n = 15) na usoro ọgwụgwọ dose-expansion n'ime otu anọ dị iche iche (n = 83): otu 1, otu satri-cel monotherapy na ndị ọrịa 61 nwere ọrịa kansa afọ na-anaghị anabata chemotherapy; otu 2, otu satri-cel na ọgwụgwọ anti-PD-1 na ndị ọrịa 15 nwere ọrịa kansa afọ na-anaghị anabata chemotherapy; otu 3, otu satri-cel dị ka ọgwụgwọ usoro mgbe ọgwụgwọ mbụ gasịrị na ndị ọrịa ise nwere ọrịa kansa afọ na-anaghị anabata chemotherapy; na otu 4, otu satri-cel monotherapy na ndị ọrịa abụọ nwere ọrịa kansa afọ na-anaghị anabata CLDN18.2 monoclonal antibody-refractory. Isi ihe dị na njedebe bụ nchekwa; isi ihe ndị dị na njedebe nke abụọ gụnyere irè, pharmacokinetics na immunogenicity. Ngụkọta nke ndị ọrịa 98 natara ọgwụ satri-cel, n'ime ha ka e nyere 89 ọgwụ 2.5 × 108, isii nwere 3.75 × 108 na atọ nwere mkpụrụ ndụ CAR T 5.0 × 108. Nleba anya etiti bụ ọnwa 32.4 (95% oge ntụkwasị obi (CI): 27.3, 36.5) kemgbe apheresis. Akọpụtaghị ihe ndị na-egbochi ọgwụ, ọnwụ metụtara ọgwụgwọ ma ọ bụ ọrịa neurotoxicity metụtara mkpụrụ ndụ. Cytokine release syndrome mere na 96.9% nke ndị ọrịa, ha niile bụ ọkwa 1–2. Achọpụtara mmerụ ahụ mucosal afọ na ndị ọrịa asatọ (8.2%). Ọnụego nzaghachi na ọnụego njikwa ọrịa n'ime ndị ọrịa 98 niile bụ 38.8% na 91.8%, n'otu n'otu, ndụ etiti na-enweghị ọganihu na ndụ zuru oke bụ ọnwa 4.4 (95% CI: 3.7, 6.6) na ọnwa 8.8 (95% CI: 7.1, 10.2), n'otu n'otu. Satri-cel na-egosi ikike ọgwụgwọ yana profaịlụ nchekwa a na-achịkwa na ndị ọrịa nwere ọrịa kansa eriri afọ CLDN18.2-positive.
Banyere Satri-cel
Satri-cel bụ ọgwụ CAR T-cell nke nwere ike ịbụ nke mbụ n'ụwa niile. Satri-cel na-elekwasị anya na ọgwụgwọ nke etuto siri ike dị mma nke Claudin18.2, nke lekwasịrị anya na kansa afọ/gastroesophageal junction cancer (GC/GEJ) na kansa pancreatic (PC). Nnwale ndị a na-eme ugbu a gụnyere nnwale ndị onye nyocha malitere (CT041-CG4006, NCT03874897), nnwale ahụike nke Phase II maka GC/GEJ dị elu na China (CT041-ST-01, NCT04581473), nnwale ahụike nke Phase I maka ọgwụgwọ PC adjuvant na China (CT041-ST-05, NCT05911217), na nnwale ahụike nke Phase 1b/2 maka adenocarcinoma afọ ma ọ bụ pancreas dị elu na North America (CT041-ST-02, NCT04404595). E nyere Satri-cel aha Regenerative Medicine Advanced Therapy (RMAT) site na US FDA maka ọgwụgwọ nke ọrịa kansa afọ dị elu nke nwere etuto Claudin18.2 dị mma na Jenụwarị 2022, EMA nyekwara ya ikike PRIME maka ọgwụgwọ nke ọrịa kansa afọ dị elu na Nọvemba 2021. Satri-cel natara aha ọgwụ Orphan site na US FDA na 2020 maka ọgwụgwọ nke GC/GEJ na aha ngwaahịa Orphan Medicinal Product site na EMA na 2021 maka ọgwụgwọ nke ọrịa kansa afọ dị elu.
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
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Ntụaka
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
Oge ozi: Febụwarị-27-2025