Muri Kanama 2025, Ikigo gishinzwe Isuzuma ry'Imiti (CDE) cy'Ikigo cy'Igihugu gishinzwe Ibikoresho by'Ubuvuzi (NMPA) cyemereye ku mugaragaro Itangwa rya Breakthrough Therapy kuri Ina-cel, uburyo bushya bwo kuvura uturemangingo twa CAR-T duyobowe na CD19 bwakozwe na Juventas ku giti cyabwo, kugira ngo buvure abana bafite kanseri y'amaraso ya B-cell acute lymphoblastic leukemia (r/r B-ALL) yasubiwemo cyangwa yasubitswe.
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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Inaticabtagene autoleucel (Inati-cel) ni umuti wa CD19-specific chimeric antigen receptor (CAR) T-cells, urimo CD19 scFv ikomoka kuri clone HI19α na 4-1BB/CD3-ζ costimulatory domain, byemejwe mu Bushinwa ku barwayi bakuru bafite leukemia ya B-acute lymphoblastic leukemia (r/r B-ALL) yasubiwemo cyangwa yasubiwemo mu Gushyingo 2023.
ItsindaInama ngarukamwaka ya ASCO yo mu 2025 raporo ubushakashatsi bw’ibintu nyabyo bukorwa mu nzego nyinshi, butari ubw’inyongera (NCT06450067) kugira ngo hasuzumwe Inati-cel ku barwayi bakuru ba B-ALL. Hagati ya 20 Ugushyingo 2023, na 13 Ugushyingo 2024, abarwayi 62 bahawe Inati-cel kandi barasuzumwe. Impuzandengo y’imyaka yari 37.5 (ifite hagati y’imyaka 14 na 76), aho abarwayi 13 bari bafite imyaka ≥60. Mu isuzuma, abarwayi 16 bongeye kugaragara nyuma yo gutera uturemangingo tw’amaraso mu maraso (HSCT), abarwayi 4 bari bafite ibibazo byo kwangirika kw’ibanze, kandi abarenga 70% by’abarwayi bari bafite ikibazo gikomeye cyo kwangirika kw’uturemangingo. Igipimo cy’impuzandengo cy’umuti watewe cyari 0.60 (ifite hagati y’imyaka 0.46 na 0.9) ×10Uturemangingo tuzima twa 8CAR-T.
Ibisubizo: Imibare yo ku ya 30 Ukuboza 2024, hamwe n'ikurikirana ry'amezi 3.8 (igihe: amezi 0.5–12.4), 89.5% babonye ORR ya MRD-negative nyuma ya Inati-cel mu barwayi ba r/r, barimo 31 bafite CR na 3 bafite CRi (imbonerahamwe ya 1). Abarwayi icyenda bafite MRD-negative ubwo basuzumwaga, igipimo cya MRD-negativity cyageze kuri 100% nyuma ya Inati-cel. Nyuma ya Inati-cel, abarwayi 26 basanze ibisubizo bya MRD hakoreshejwe q-PCR, naho 92.3% babona ibisubizo bibi. Nyuma yo kubona CR/CRi, abarwayi 4 barangije bakorerwa allo-HSCT mu gihe cyo kuruhuka. Igipimo cya DOR, OS na RFS nticyagezweho hamwe n'abarwayi bakurikiraho ba allo-HSCT kandi batabanje kubagenzura. Mu barwayi bapimwe, igipimo cya RFS na DOR cy'umwaka umwe cyari 76.2% na 74.1%, uko bikurikirana. Abarwayi barindwi basubiye inyuma, harimo 3 CD19+ zongeye kugaruka, 2 CD19 zongeye kugaruka, na 2 zitaramenyekana neza uko CD19 ihagaze. Ni ngombwa kumenya ko mu barwayi 6 barwaye indwara iturutse hanze ya medullary, 4 zagize ingaruka nziza, ariko 2 zongeye kugaruka mu mezi 3 nyuma ya Inati-cel. Abarwayi bose bahawe Inati-cel bari bazima, uretse urupfu rumwe rwatewe n’indwara. Ingaruka mbi zikunze kugaragara cyane (AEs) ni indwara ya cytokine release syndrome (CRS) na immuno effect cell-associated neurotoxicity syndrome (ICANS). Mirongo itanu na kimwe ku ijana by’abarwayi barwaye CRS, ariko CRS na ICANS zo mu cyiciro cya 3 cyangwa hejuru zabaye gusa kuri 3.2% na 1.6% by’abarwayi, uko bikurikirana; abarwayi bose bakize nta ngaruka zibayeho, nta rupfu rufitanye isano na AE.
Ikoreshwa rya Inati-cel mu buryo bufatika rigaragaza ko ORR iri hejuru ya MRD-negative muri B-ALL y'abantu bakuru. Uburyo bw'umutekano bwashobotse, aho umubare muto wa CRS na ICANS byo mu rwego rwa ≥3 mu buryo busanzwe. Amakuru maremare azakurikiranwa azagaragazwa.
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.
Nimero ya Terefone: 4008803716
Indangamuntu ya WeChat: 17801183037
Email：myimmnet@163.com
Igihe cyo kohereza: Kanama-26-2025