Ku ya 21 Gashyantare 2025, Ikigo gishinzwe Isuzuma ry'Imiti (CDE) cy'Ikigo cy'Igihugu gishinzwe Ibikoresho by'Ubuvuzi mu Bushinwa (NMPA) cyatanze inyito yo kuvura indwara ya “Breakthrough Therapy Designation (BTD)” ku ndwara ya Satri-cel (CT041) (umuti wa CAR T-cell candidate urwanya Claudin18.2), ku ndwara ya “advanced gastric/esophagogastric junction” (G/GEJ) adenocarcinoma ifite Claudin18.2 (CLDN18.2) yabanje kunanirwa kuvura nibura ku rwego rwa kabiri.
Igerageza ryatangijwe n’umushakashatsi CT041-CG4006 (NCT03874897) rya satricabtagene autoleucel (“satri-cel”, CT041) (ikintu cy’uturemangingo twa CAR T-cells cyakozwe na Claudin18.2) ryasohotse mu kinyamakuru Nature Medicine ku ya 3 Kamena 2024.
Iri gerageza ryakozwe mu cyiciro cyo kongera urugero rw'umuti (n = 15) n'icyiciro cyo kongera urugero rw'umuti mu byiciro bine bitandukanye (byose hamwe n = 83): itsinda rya mbere, satri-cel monotherapy ku barwayi 61 bafite kanseri isanzwe ya kanseri y'igifu iterwa na chemotherapy; itsinda rya kabiri, satri-cel hamwe n'ubuvuzi bwa anti-PD-1 ku barwayi 15 bafite kanseri isanzwe ya kanseri y'igifu iterwa na chemotherapy; itsinda rya gatatu, satri-cel nk'ubuvuzi bukurikiranye nyuma yo kuvura ku rwego rwa mbere ku barwayi batanu bafite kanseri y'igifu; na itsinda rya kane, satri-cel monotherapy ku barwayi babiri bafite kanseri y'igifu iterwa na CLDN18.2 monoclonal antibody. Ingaruka nyamukuru yari umutekano; inyongera ya kabiri yarimo gukora neza, pharmacokinetics na immunogenicity. Abarwayi 98 bose hamwe bahawe satri-cel, muri bo 89 bahawe 2.5 × 108, batandatu bafite 3.75 × 108 na batatu bafite selile za CAR T 5.0 × 108. Ikurikirana ry’igihembwe cya kabiri ryari amezi 32.4 (95% by’icyizere (CI): 27.3, 36.5) kuva apheresis yatangira. Nta burozi bugabanya urugero rw’umuti, impfu ziterwa no kuvurwa cyangwa indwara y’ubudahangarwa bw’uturemangingo yagaragaye. Indwara yo gusohora cytokine yagaragaye ku barwayi 96.9%, bose bashyizwe mu cyiciro cya 1-2. Ibikomere byo mu gifu byagaragaye ku barwayi umunani (8.2%). Igipimo rusange cy’ubwitabire n’igipimo cyo kurwanya indwara ku barwayi bose 98 cyari 38.8% na 91.8%, uko bikurikirana, naho ikigereranyo cy’impinduka mu mikorere no kubaho muri rusange cyari amezi 4.4 (95% CI: 3.7, 6.6) n’amezi 8.8 (95% CI: 7.1, 10.2), uko bikurikirana. Satri-cel igaragaza ubushobozi bwo kuvura hamwe n’umutekano muke ku barwayi barwaye kanseri y’igifu ya CLDN18.2-positive.
Ibyerekeye Satri-cel
Satri-cel ni ubwoko bwa CAR T-cells bushobora kuba ubwa mbere ku isi. Satri-cel igamije kuvura ibibyimba bikomeye bya Claudin18.2, ikaba yibanda cyane ku kanseri y'igifu/kanseri y'uruhu rw'umuyoboro w'amaraso (GC/GEJ) na kanseri y'urusenda (PC). Igerageza ririmo igerageza ryatangijwe n'abashakashatsi (CT041-CG4006, NCT03874897), igerageza ry'icyiciro cya kabiri cy'ubuvuzi ku ndwara ya GC/GEJ mu Bushinwa (CT041-ST-01, NCT04581473), igerageza ry'icyiciro cya mbere cy'ubuvuzi bwunganira PC mu Bushinwa (CT041-ST-05, NCT05911217), n'igerageza ry'icyiciro cya 1b/2 cy'uburwayi bwa kanseri y'igifu cyangwa kanseri y'urusenda muri Amerika y'Amajyaruguru (CT041-ST-02, NCT04404595). Satri-cel yahawe urwego rwa Regenerative Medicine Advanced Therapy (RMAT) na FDA yo muri Amerika mu kuvura kanseri y’igifu iteye imbere ya GC/GEJ ifite Claudin18.2 muri Mutarama 2022, kandi yahawe uburenganzira bwa PRIME na EMA mu kuvura kanseri y’igifu iteye imbere mu Gushyingo 2021. Satri-cel yahawe urwego rwa Orphan Drug na FDA yo muri Amerika mu 2020 mu kuvura kanseri y’igifu iteye imbere ya GC/GEJ na Orphan Medicinal Product ya EMA mu 2021 mu kuvura kanseri y’igifu iteye imbere.
Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.
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Amareferensi
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
Igihe cyo kohereza: Gashyantare-27-2025