Ngomhla wama-30 kuJulayi, iNational Medical Products Administration (NMPA) yavuma ngokusesikweni ukuthengiswa kwe-HICARA kunyango lwabantu abadala abane-relapse okanye refractory large B-cell lymphoma (r/r LBCL) abaye bafumana iindlela ezimbini okanye ngaphezulu zonyango lwenkqubo. Oku kuquka i-diffuse large B-cell lymphoma, engachazwanga ngenye indlela (DLBCL, NOS); i-diffuse large B-cell lymphoma eguqulwe kwi-follicular lymphoma; i-high-grade B-cell lymphoma ene-MYC kunye ne-BCL2 rearrangements; kunye ne-high-grade B-cell lymphoma, engachazwanga ngenye indlela (HGBL, NOS).
Oku kubonisa imveliso yokuqala ye-CD19 CAR-T ephuhliswe ngokupheleleyo eTshayina ejolise ngokukodwa kwi-relapse okanye refractory large B-cell lymphoma (r/r LBCL). Uphando, uphuhliso, kunye nokuveliswa kwe-HICARA kuxhomekeke ngokupheleleyo kuyilo lweemolekyuli ze-Hrain Biotechnology, inkqubo yomgangatho wenkqubo esekwe ngokuzimeleyo, kunye neqonga lemveliso elikhulu nelivaliweyo. Le mpumelelo ifezekisa ukwenziwa ngokupheleleyo kophuhliso kunye nemveliso yeeseli ze-CAR-T, iphula ii-monopolies zobuchwepheshe bamanye amazwe. Okuphawulekayo kukuba, i-HICARA yimveliso yokuqala evunyiweyo ye-CAR-T yasekhaya ukwamkela inkqubo ye-vector yeseli ezinzileyo.
Ngokweziphumo zovavanyo lweSigaba sesiBini se-HRAIN01-NHL01-II (NCT05436223) ezivezwe ngexesha leNtlanganiso yoNyaka ye-American Association for Cancer Research (AACR) ka-2024, i-HICARA ibonise iimpendulo ezisebenzayo kwizigulana ezine-lymphoma ebuyela umva/engaguqukiyo engeyiyo iHodgkin.
Iziphumo: Ukusukela nge-16 kaMeyi, 2023, izigulane ezingama-81 ze-R/R NHL ezine-ECOG 0-1 ekuqaleni zafumana i-infusion HR001 kwi-Jinshan manufacturing facility [51.9% yamadoda; ubudala obuphakathi buyiminyaka engama-53.4 (uluhlu lwama-23 ~ 74); 3.7% i-CD19 negative; 91.4% i-diffuse large B-cell lymphoma; 79.0% III-IV ye-Ann Arbor classification okanye iLugano] kunye nokulandelelana okuphakathi kweentsuku ezili-160 (uluhlu oluvela kwi-7 ukuya kwi-454). Ixesha eliphakathi lokuphendula okungcono yayiziintsuku ezingama-30 (uluhlu lwama-28-358). Izinga lempendulo egqibeleleyo yeenyanga ezi-3, iinyanga ezi-6 kunye neyona ilungileyo (ORR) yayiyi-53.1% (95% CI: 41.7-64.3), 45.7% (95% CI: 34.6-57.1) kunye ne-74.1% (95% CI: 63.1-83.2) ngokwahlukeneyo. Izinga lempendulo epheleleyo yeenyanga ezi-3, iinyanga ezi-6 kunye neyona ilungileyo (CRR) yayiyi-32.1% (95% CI: 22.2-43.4), 29.6% (95% CI: 20.0-40.8) kunye ne-49.4% (95% CI: 38.1-60.7) ngokwahlukeneyo. Ubude bexesha eliphakathi lempendulo (DOR) kunye nokusinda okungenankqubela phambili (PFS) yayiziintsuku ezingama-339 (95% CI: 149-NE) kunye neentsuku ezili-176 (95% CI: 91-NE) ngokwahlukeneyo. Ukusinda kukonke (OS) akufikelelwanga. Ezona ziganeko zixhaphakileyo ezinxulumene nonyango (ii-AE) zenzeka kwinkqubo ye-hematologic. I-cytokine release syndrome (i-CRS) yenzeka kwi-95.1% yezigulane, apho i-≥3 grade CRS ibonwe kwi-3.7% yezigulane. I-immunoeffector cell-associated neurotoxicity syndrome (i-ICANS) yenzeka kwi-8.6% yezigulane, ngaphandle kokuba i-ICANS ye-≥3 grade ibike. Ukufa okunxulumene nonyango yayiyi-1.2%. Ixesha eliphakathi lokwanda kwe-CAR T-cell peak yayiziiyure ezingama-240 (120~672) emva kokufakwa, i-median maximum expansion (i-Cmax) yayiyi-17413.9 copies/μg DNA (124.9~136382.2), kunye ne-median AUC0-28dyayiyi-3201014.0 copies/μg DNA (205082.8~18400016.2). Uvavanyo oluqinisekileyo lwe-anti-drug antibody (ADA) luqatshelwe kwi-14.8% yezigulane, ngelixa uvavanyo lwe-neutralizing antibody (Nab) luchaziwe kwi-3.7% yezigulane. Phakathi kwezigulane ezine-Nab, impendulo epheleleyo igcinwe de kwalandela.
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
Ixesha leposi: Julayi-31-2025