Ngomhlaka-30 kuJulayi, i-National Medical Products Administration (NMPA) yavuma ngokusemthethweni ukumaketha kwe-HICARA ekwelapheni iziguli ezindala ezine-lymphoma enkulu ye-B-cell ephinde yabuya noma engaphikisi (r/r LBCL) ezithole imigqa emibili noma ngaphezulu yokwelashwa okuhleliwe. Lokhu kufaka phakathi i-lymphoma enkulu ye-B-cell esakazekile, engachazwanga ngenye indlela (i-DLBCL, i-NOS); i-lymphoma enkulu ye-B-cell eshintshekile kusuka ku-follicular lymphoma; i-lymphoma ye-B-cell ephezulu ene-MYC kanye ne-BCL2 rearrangments; kanye ne-lymphoma ye-B-cell ephezulu, engachazwanga ngenye indlela (i-HGBL, i-NOS).
Lokhu kuwumkhiqizo wokuqala we-CD19 CAR-T othuthukiswe ngokuphelele eShayina oqondiswe ngqo ku-relapse noma refractory large B-cell lymphoma (r/r LBCL). Ucwaningo, ukuthuthukiswa, kanye nokukhiqizwa kwe-HICARA kuncike ngokuphelele ekwakhiweni kwama-molecule kwe-Hrain Biotechnology, uhlelo lwekhwalithi yenqubo olusungulwe ngokuzimela, kanye nepulatifomu yokukhiqiza evaliwe, enkulu. Le mpumelelo ifezekisa ukufuywa okuphelele kokuthuthukiswa nokukhiqizwa kwamaseli e-CAR-T, okuphula ukulawulwa kobuchwepheshe bangaphandle. Okuphawulekayo ukuthi i-HICARA ingumkhiqizo wokuqala we-CAR-T ovunyelwe ngaphakathi ezweni ukwamukela inqubo ye-vector yegciwane ezinzile yeseli.
Ngokwemiphumela yesivivinyo seSigaba II se-HRAIN01-NHL01-II (NCT05436223) esethulwe ngesikhathi soMhlangano Waminyaka Yonke we-American Association for Cancer Research (AACR) ka-2024, i-HICARA ibonise izimpendulo ezisebenzayo ezigulini ezine-lymphoma engaphili kahle/engaguquki.
Imiphumela: Kusukela ngomhlaka-16 Meyi 2023, iziguli ezingu-81 ze-R/R NHL ezine-ECOG 0-1 ekuqaleni zathola i-infusion HR001 evela esikhungweni sokukhiqiza i-Jinshan [abesilisa abangu-51.9%; ubudala obuphakathi buyiminyaka engu-53.4 (ububanzi obungu-23~74); 3.7% i-CD19 negative; 91.4% i-diffuse large B-cell lymphoma; 79.0% III-IV ye-Ann Arbor classification noma i-Lugano] ngokulandelwa okuphakathi kwezinsuku ezingu-160 (ububanzi obungu-7 kuya ku-454). Isikhathi esiphakathi sempendulo engcono kakhulu kwakuyizinsuku ezingu-30 (ububanzi obungu-28-358). Izinga lokuphendula eliphelele lezinyanga ezi-3, izinyanga ezi-6 kanye nelingcono kakhulu (ORR) lalingu-53.1% (95% CI: 41.7-64.3), 45.7% (95% CI: 34.6-57.1) kanye no-74.1% (95% CI: 63.1-83.2) ngokulandelana. Izinga lokuphendula eliphelele lezinyanga ezi-3, izinyanga ezi-6 kanye nelingcono kakhulu (CRR) lalingu-32.1% (95% CI: 22.2-43.4), 29.6% (95% CI: 20.0-40.8) kanye no-49.4% (95% CI: 38.1-60.7) ngokulandelana. Ubude besikhathi esimaphakathi sempendulo (DOR) kanye nokusinda okungenalo ukuqhubekela phambili (PFS) kwakuyizinsuku ezingu-339 (95% CI: 149-NE) kanye nezinsuku ezingu-176 (95% CI: 91-NE) ngokulandelana. Ukusinda okuphelele (i-OS) akufinyelelwanga. Izehlakalo ezimbi ezihlobene nokwelashwa (ama-AE) ezivame kakhulu zenzeka ohlelweni lwegazi. I-cytokine release syndrome (i-CRS) yenzeka ku-95.1% weziguli, kanti i-CRS yebanga elingu-≥3 yabonwa ku-3.7% weziguli. I-immunoeffector cell-associated neurotoxicity syndrome (i-ICANS) yenzeka ku-8.6% weziguli, ngaphandle kokuthi kubikwe noma yikuphi i-ICANS yebanga elingu-≥3. Ukufa okuhlobene nokwelashwa kwaba ngu-1.2%. Isikhathi esimaphakathi sokwanda kwe-CAR T-cell kwaba amahora angu-240 (120~672) ngemuva kokufakwa, ukwanda okuphezulu okumaphakathi (i-Cmax) kwaba amakhophi angu-17413.9/μg DNA (124.9~136382.2), kanye ne-AUC emaphakathi.0-28dkwakuyikhophi ezingama-3201014.0/μg DNA (205082.8~18400016.2). Ukuhlolwa okuhle kwe-antibody yokulwa nezidakamizwa (i-ADA) kwaphawulwa ku-14.8% weziguli, kuyilapho ukuhlolwa kwe-antibody yokungazweli (i-Nab) kwabonakala ku-3.7% weziguli. Phakathi kweziguli ezine-Nab, impendulo ephelele yagcinwa kuze kube yilapho kulandelwa.
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
Isikhathi sokuthunyelwe: Julayi-31-2025