Thaum Lub Xya Hli 30, Lub Koom Haum Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau pom zoo rau kev lag luam ntawm HICARA rau kev kho mob rau cov neeg laus uas muaj mob rov qab los yog mob hnyav B-cell lymphoma (r/r LBCL) uas tau txais ob lossis ntau kab kev kho mob. Qhov no suav nrog diffuse large B-cell lymphoma, tsis tau teev tseg (DLBCL, NOS); diffuse large B-cell lymphoma hloov pauv los ntawm follicular lymphoma; high-grade B-cell lymphoma nrog MYC thiab BCL2 rearrangements; thiab high-grade B-cell lymphoma, tsis tau teev tseg (HGBL, NOS).
Qhov no yog thawj lub tuam txhab CD19 CAR-T uas tau tsim tawm hauv Suav teb uas tsom mus rau cov kab mob loj B-cell lymphoma (r/r LBCL). Kev tshawb fawb, kev txhim kho, thiab kev tsim khoom ntawm HICARA vam khom tag nrho rau Hrain Biotechnology txoj kev tsim qauv molecular, kev tsim cov txheej txheem zoo, thiab lub platform loj. Qhov kev ua tiav no ua rau muaj kev tsim kho thiab tsim cov cell CAR-T tag nrho, rhuav tshem cov kev lag luam txawv teb chaws. Qhov tseem ceeb, HICARA yog thawj lub tuam txhab CAR-T uas tau pom zoo hauv tebchaws los txais yuav cov txheej txheem cell viral vector ruaj khov.
Raws li cov txiaj ntsig ntawm Theem II HRAIN01-NHL01-II kev sim (NCT05436223) uas tau nthuav tawm thaum lub rooj sib tham txhua xyoo ntawm American Association for Cancer Research (AACR) xyoo 2024, HICARA tau ua pov thawj tias muaj txiaj ntsig zoo rau cov neeg mob uas muaj mob lymphoma uas rov qab los/tsis khov kho uas tsis yog Hodgkin.
Cov Txiaj Ntsig: Txij li thaum Lub Tsib Hlis 16, 2023, 81 tus neeg mob R/R NHL uas muaj ECOG 0-1 thaum pib tau txais cov tshuaj HR001 los ntawm lub chaw tsim khoom Jinshan [51.9% txiv neej; hnub nyoog nruab nrab 53.4 xyoo (ntau yam 23~74); 3.7% CD19 tsis zoo; 91.4% diffuse large B-cell lymphoma; 79.0% III-IV ntawm Ann Arbor kev faib tawm lossis Lugano] nrog rau kev saib xyuas nruab nrab ntawm 160 hnub (ntau yam 7 txog 454). Lub sijhawm nruab nrab rau kev teb zoo tshaj plaws yog 30 hnub (ntau yam 28-358). Tus nqi teb 3-hli, 6-hli thiab qhov zoo tshaj plaws (ORR) yog 53.1% (95% CI: 41.7-64.3), 45.7% (95% CI: 34.6-57.1) thiab 74.1% (95% CI: 63.1-83.2) raws li. Tus nqi teb 3-hli, 6-hli thiab qhov zoo tshaj plaws (CRR) yog 32.1% (95% CI: 22.2-43.4), 29.6% (95% CI: 20.0-40.8) thiab 49.4% (95% CI: 38.1-60.7) raws li. Lub sijhawm nruab nrab ntawm kev teb (DOR) thiab kev ciaj sia tsis muaj kev nce qib (PFS) yog 339 hnub (95% CI: 149-NE) thiab 176 hnub (95% CI: 91-NE) raws li. Tsis tau txog qhov muaj sia nyob tag nrho (OS). Cov teeb meem tshwm sim los ntawm kev kho mob (AEs) feem ntau tshwm sim hauv lub cev ntshav. Cov tsos mob cytokine tso tawm (CRS) tshwm sim hauv 95.1% ntawm cov neeg mob, nrog rau ≥3 qib CRS pom hauv 3.7% ntawm cov neeg mob. Cov tsos mob neurotoxicity ntawm lub cev tiv thaiv kab mob (ICANS) tshwm sim hauv 8.6% ntawm cov neeg mob, tsis muaj ≥3 qib ICANS tau tshaj tawm. Kev tuag los ntawm kev kho mob yog 1.2%. Lub sijhawm nruab nrab rau CAR T-cell nthuav dav yog 240 teev (120 ~ 672) tom qab infusion, qhov nruab nrab siab tshaj plaws nthuav dav (Cmax) yog 17413.9 daim / μg DNA (124.9 ~ 136382.2), thiab nruab nrab AUC0-28 hnubyog 3201014.0 daim/μg DNA (205082.8~18400016.2). Cov kev kuaj pom tias muaj cov tshuaj tiv thaiv kab mob (ADA) zoo hauv 14.8% ntawm cov neeg mob, thaum cov kev kuaj tsis muaj zog (Nab) zoo hauv 3.7% ntawm cov neeg mob. Ntawm cov neeg mob uas muaj Nab, cov lus teb tag nrho tau khaws cia kom txog thaum rov qab los.
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
Lub sijhawm tshaj tawm: Lub Xya Hli-31-2025