Ngo-Agasti 2025, i-Center for Drug Evaluation (CDE) ye-National Medical Products Administration (NMPA) yanikeza ngokusemthethweni i-Breakthrough Therapy Designation ku-Ina-cel, ukwelashwa okusha kweseli le-CAR-T okuqondiswa yi-CD19 okwakhiwe ngokuzimela yi-Juventas, ukuze kwelashwe iziguli zezingane ezine-B-cell acute lymphoblastic leukemia (r/r B-ALL) ephinde yabuyela esimweni sayo noma engaphikisi.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
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I-Inaticabtagene autoleucel (I-Inati-cel) umkhiqizo we-T-cell we-chimeric antigen receptor (CAR) we-CD19, oqukethe i-CD19 scFv ethathwe ku-clone HI19α kanye ne-4-1BB/CD3-ζ costimulatory domain, eyavunywa eShayina kwiziguli ezindala ezine-B-acute lymphoblastic leukemia ephinde yabuya noma engaphikisi (r/r B-ALL) ngoNovemba 2023.
IUmhlangano Waminyaka Yonke we-ASCO ka-2025 umbiko Ucwaningo lwangempela oluhlanganisa izikhungo eziningi, olungangeneleli (NCT06450067) lokuhlola i-Inati-cel yeziguli ezindala ze-B-ALL. Phakathi kukaNovemba 20, 2023, kanye noNovemba 13, 2024, iziguli ezingu-62 zathola i-Inati-cel futhi zahlolwa. Ubudala obumaphakathi babuyiminyaka engu-37.5 (ibanga, 14-76), kanye neziguli ezingu-13 ezineminyaka engu-≥60. Ekuhlolweni, amacala angu-16 aphinde abuya ngemva kokufakelwa kweseli le-hematopoietic stem cell (HSCT), amacala angu-4 ayengaguquki, kanti iziguli ezingaphezu kuka-70% zazinokukhubazeka kofuzo okuyingozi kakhulu. Umthamo omaphakathi wokufakwa wawungu-0.60 (ibanga: 0.46-0.9) ×10Amaseli aphilayo angu-8CAR-T.
Imiphumela: Idatha kusukela ngoDisemba 30, 2024, ngokulandelwa okumaphakathi kwezinyanga ezingu-3.8 (ububanzi: izinyanga ezingu-0.5–12.4), u-89.5% uthole i-MRD-negative ORR ngemuva kwe-Inati-cel ezigulini ze-r/r, kufaka phakathi ezingu-31 ezine-CR kanye nezingu-3 ezine-CRi (ithebula 1). Iziguli eziyisishiyagalolunye ezine-MRD-positive ekuhlolweni, izinga le-MRD-negativity lifinyelele ku-100% ngemuva kwe-Inati-cel. Ngemuva kwe-Inati-cel, iziguli ezingu-26 zathola imiphumela ye-MRD nge-q-PCR, kanti u-92.3% wathola imiphumela emibi. Ngemva kokuthola i-CR/CRi, iziguli ezingu-4 kamuva zithole i-allo-HSCT ekukhululweni. I-DOR, i-OS kanye ne-RFS emaphakathi azikafinyelelwanga kanye nangaphandle kokuhlolwa kweziguli ku-allo-HSCT elandelayo. Phakathi kweziguli ezihlolwayo, amazinga e-RFS kanye ne-DOR onyaka owodwa ayengu-76.2% kanye no-74.1%, ngokulandelana. Iziguli eziyisikhombisa zabhekana nokubuyela emuva kwesifo, okuhlanganisa ukuphindaphinda okungu-3 kwe-CD19+, ukuphindaphinda okungu-2 kwe-CD19, kanye no-2 ongenaso isimo se-CD19 esingacacile. Kubalulekile ukuqaphela ukuthi ezimweni ezingu-6 zesifo sangaphandle kwe-medullary, amacala angu-4 asebenza kahle, kodwa amacala amabili aphinde abuyela emuva zingakapheli izinyanga ezi-3 ngemuva kwe-Inati-cel. Zonke iziguli ezathola ukumnika i-Inati-cel zaziphila, ngaphandle kokufa okukodwa ngenxa yokuqhubeka kwesifo. Izehlakalo ezimbi ezivame kakhulu (ama-AE) ezithakazelisa kakhulu kwakuyi-cytokine release syndrome (CRS) kanye ne-immune effector cell-associated neurotoxicity syndrome (ICANS). Amaphesenti angamashumi amahlanu nanye eziguli athola i-CRS, kodwa ama-CRS nama-ICANS ebanga lesi-3 noma ngaphezulu enzeka kuphela ku-3.2% kanye no-1.6% weziguli, ngokulandelana; zonke iziguli zithola ukwelashwa ngaphandle kwemiphumela emibi, azikho ukufa okuhlobene ne-AE.
Ukusetshenziswa kwangempela kwe-Inati-cel kubonisa i-ORR ephezulu engemihle ye-MRD ku-B-ALL yabantu abadala. Iphrofayili yokuphepha yayilawuleka, kanye nezinga eliphansi le-CRS kanye ne-ICANS zebanga elingu-≥3 esimweni sangempela. Kuzovezwa idatha ende yokulandelela.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Isikhathi sokuthunyelwe: Agasti-26-2025