Pa Julayi 30, bungwe la National Medical Products Administration (NMPA) linavomereza mwalamulo kutsatsa kwa HICARA pochiza odwala akuluakulu omwe ali ndi lymphoma ya B-cell yobwereranso kapena yokana (r/r LBCL) yomwe yalandira njira ziwiri kapena zingapo zothandizira. Izi zikuphatikizapo lymphoma ya B-cell yofalikira, yomwe sinatchulidwe mwanjira ina (DLBCL, NOS); lymphoma ya B-cell yofalikira yomwe yasinthidwa kuchokera ku follicular lymphoma; lymphoma ya B-cell yapamwamba yokhala ndi MYC ndi BCL2 rearrangements; ndi lymphoma ya B-cell yapamwamba, yomwe sinatchulidwe mwanjira ina (HGBL, NOS).
Ichi ndi chinthu choyamba cha CD19 CAR-T chopangidwa bwino mdziko muno ku China chomwe chimayang'ana kwambiri large B-cell lymphoma (r/r LBCL). Kafukufuku, chitukuko, ndi kupanga HICARA kumadalira kwathunthu kapangidwe ka molekyulu ka Hrain Biotechnology, njira yodziyimira payokha yopangira zinthu, komanso nsanja yayikulu yopanga zinthu. Kupambana kumeneku kukukwaniritsa kufalikira kwathunthu kwa chitukuko ndi kupanga kwa maselo a CAR-T, ndikuswa ma monopolies akunja aukadaulo. Chodziwika bwino ndichakuti, HICARA ndiye chinthu choyamba cha CAR-T chovomerezedwa mdziko muno kugwiritsa ntchito njira yokhazikika ya cell line viral vector.
Malinga ndi zotsatira za mayeso a Gawo Lachiwiri la HRAIN01-NHL01-II (NCT05436223) omwe adaperekedwa pa Msonkhano Wapachaka wa American Association for Cancer Research (AACR) wa 2024, HICARA idawonetsa mayankho ogwira mtima mwa odwala omwe ali ndi lymphoma yobwereranso/yosasinthika ya non-Hodgkin.
Zotsatira: Pofika pa Meyi 16, 2023, odwala 81 a R/R NHL omwe anali ndi ECOG 0-1 poyamba adalandira infusion HR001 kuchokera ku Jinshan manufacturing facility [51.9% amuna; apakatikati zaka 53.4 (zaka 23~74); 3.7% CD19 negative; 91.4% kufalitsa large B-cell lymphoma; 79.0% III-IV ya Ann Arbor classification kapena Lugano] ndi apakatikati kutsatira kwa masiku 160 (zaka 7 mpaka 454). Nthawi yapakati yoyankhira bwino inali masiku 30 (zaka 28-358). Chiŵerengero cha mayankho abwino kwambiri (ORR) cha miyezi itatu, miyezi isanu ndi umodzi komanso chabwino kwambiri (ORR) chinali 53.1% (95% CI: 41.7-64.3), 45.7% (95% CI: 34.6-57.1) ndi 74.1% (95% CI: 63.1-83.2) motsatana. Chiŵerengero cha mayankho abwino kwambiri a miyezi itatu, miyezi isanu ndi umodzi komanso abwino kwambiri (CRR) chinali 32.1% (95% CI: 22.2-43.4), 29.6% (95% CI: 20.0-40.8) ndi 49.4% (95% CI: 38.1-60.7) motsatana. Nthawi yapakati yoyankha (DOR) ndi kupulumuka kosapitirira muyeso (PFS) inali masiku 339 (95% CI: 149-NE) ndi masiku 176 (95% CI: 91-NE) motsatana. Kupulumuka konse (OS) sikunakwaniritsidwe. Zochitika zoyipa zokhudzana ndi chithandizo (AEs) zomwe zimachitika kawirikawiri zimachitika mu dongosolo la magazi. Matenda a cytokine release syndrome (CRS) adachitika mwa 95.1% ya odwala, ndipo CRS ya ≥3 grade idawonedwa mwa 3.7% ya odwala. Matenda a immunoeffector cell-associated neurotoxicity syndrome (ICANS) adachitika mwa 8.6% ya odwala, popanda ICANS ya ≥3 grade idanenedwa. Imfa zokhudzana ndi chithandizo zinali 1.2%. Nthawi yapakati yofikira kukula kwa CAR T-cell inali maola 240 (120~672) pambuyo pa kulowetsedwa, kukula kwakukulu kwapakati (Cmax) kunali 17413.9 copies/μg DNA (124.9~136382.2), ndi AUC yapakati.0-28danali makope 3201014.0/μg DNA (205082.8~18400016.2). Mayeso abwino a anti-drug antibody (ADA) adapezeka mwa 14.8% ya odwala, pomwe mayeso a neutralizing antibody (Nab) anali abwino mwa 3.7% ya odwala. Pakati pa odwala omwe ali ndi Nab, yankho lonse lidapitilira mpaka atatsatiridwa.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department. Phone Number：4008803716 WeChat ID: 17801183037 Email：myimmnet@163.com
Nthawi yotumizira: Julayi-31-2025