Musi wa21 Kukadzi 2025, Center for Drug Evaluation (CDE) yeNational Medical Products Administration (NMPA) yeChina yakapa Breakthrough Therapy Designation (BTD) yeSatri-cel (CT041) (chigadzirwa cheCAR T-cell chinoonekwa sechinoda kurapwa naClaudin18.2), kune advanced gastric/esophagogastric junction (G/GEJ) adenocarcinoma ine Claudin18.2 (CLDN18.2) iyo yakambotadza kurapwa kwechipiri.
Kuedzwa kwekutanga kweCT041-CG4006 (NCT03874897) kwe satricabtagene autoleucel (“satri-cel”, CT041) (chinhu chinonzi autologous CAR T-cell product chinopesana naClaudin18.2) kwakabudiswa muNature Medicine musi wa3 Chikumi, 2024.
Kuedzwa uku kwaisanganisira danho rekuwedzera mushonga (n = 15) uye danho rekuwedzera mushonga mumapoka mana akasiyana (total n = 83): boka rekutanga, satri-cel monotherapy muvarwere makumi matanhatu nerimwe vane kenza yemudumbu isingarapike chemotherapy; boka rechipiri, satri-cel pamwe nekurapa kwePD-1 muvarwere gumi nevashanu vane kenza yemudumbu isingarapike chemotherapy; boka rechitatu, satri-cel sekurapwa kwakatevedzana mushure mekurapwa kwekutanga muvarwere vashanu vane kenza yemudumbu; uye boka rechina, satri-cel monotherapy muvarwere vaviri vane kenza yemudumbu isingarapike masero emuviri isingarapike kenza yemudumbu isingarapike masero emuviri. Mugumo mukuru waive wekuchengetedza; magumo echipiri aisanganisira kushanda zvakanaka, pharmacokinetics uye immunogenicity. Varwere vese makumi mapfumbamwe nevasere vakapihwa satri-cel infusion, pakati pavo 89 vakapihwa 2.5 × 108, vatanhatu vaine 3.75 × 108 uye vatatu vane 5.0 × 108 CAR T cells. Kutevera kwepakati kwaive kwemwedzi 32.4 (95% confidence interval (CI): 27.3, 36.5) kubva paapheresis. Hapana chepfu dzinoderedza dose, rufu rune chekuita nekurapwa kana immune effector cell-associated neurotoxicity syndrome dzakataurwa. Cytokine release syndrome yakaitika mu96.9% yevarwere, vese vakaiswa mugiredhi 1-2. Kukuvara kwemudumbu kwakaonekwa muvarwere vasere (8.2%). Kuwanda kwemhinduro uye mwero wekutonga chirwere muvarwere vese 98 vaive 38.8% uye 91.8%, zvichiteerana, uye avhareji yekurarama pasina progression uye kupona kwese kwaive mwedzi 4.4 (95% CI: 3.7, 6.6) uye mwedzi 8.8 (95% CI: 7.1, 10.2), zvichiteerana. Satri-cel inoratidza kugona kwekurapa neprofile yekuchengetedza inogoneka muvarwere vane CLDN18.2-positive advanced gastrointestinal cancer.
Nezve Satri-cel
Satri-cel chigadzirwa cheCAR T-cell chinogadzirwa nemuviri chinopesana neClaudin18.2 iyo inogona kuva yekutanga mukirasi pasi rose. Satri-cel inonangana nekurapa Claudin18.2 positive solid bundu ine chinangwa chikuru chegomarara remudumbu/gostroesophageal junction cancer (GC/GEJ) uye gomarara repancreas (PC). Miedzo iri kuenderera mberi inosanganisira miedzo yakatangwa nevaongorori (CT041-CG4006, NCT03874897), bvunzo yekusimbisa Phase II clinical ye advanced GC/GEJ muChina (CT041-ST-01, NCT04581473), bvunzo yekiriniki yePhase I yePC adjuvant therapy muChina (CT041-ST-05, NCT05911217), uye bvunzo yekiriniki yePhase 1b/2 ye advanced gastric or pancreatic adenocarcinoma muNorth America (CT041-ST-02, NCT04404595). Satri-cel yakapihwa zita rekuti Regenerative Medicine Advanced Therapy (RMAT) neUS FDA rekurapa GC/GEJ ine bundu reClaudin18.2-positive muna Ndira 2022 uye yakapihwa PRIME yekukodzera kurapwa kwegomarara remudumbu rakakwira muna Mbudzi 2021. Satri-cel yakapihwa zita rekuti Orphan Drug kubva kuUS FDA muna 2020 rekurapa GC/GEJ uye Orphan Medicinal Product kubva kuEMA muna 2021 rekurapa gomarara remudumbu rakakwira.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
Nhamba yefoni: 4008803716
Email：myimmnet@163.com
Mareferensi
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
Nguva yekutumira: Kukadzi-27-2025