Te Whakaora CD19 CAR-T Tuatahi o Haina kua Whakaaetia e HICARA mō te Lymphoma Pūtau-B Nui kua Hoki/Kua Ātete

I te 30 o Hūrae, i whakaaetia mana e te National Medical Products Administration (NMPA) te hokohoko o HICARA hei rongoā mō ngā tūroro pakeke e pāngia ana e te lymphoma pūtau-B nui kua hoki mai, kua ātete rānei ki te mate (r/r LBCL) kua whiwhi i ngā momo rongoā pūnaha e rua, neke atu rānei. Kei roto i tēnei ko te lymphoma pūtau-B nui kua horapa, kāore i tohua kētia (DLBCL, NOS); te lymphoma pūtau-B nui kua horapa kua hurihia mai i te lymphoma follicular; te lymphoma pūtau-B teitei me ngā whakarerekētanga MYC me BCL2; me te lymphoma pūtau-B teitei, kāore i tohua kētia (HGBL, NOS).

Koinei te hua CD19 CAR-T tuatahi i whakawhanakehia i roto i te motu o Haina e aro ana ki te lymphoma pūtau-B nui kua hoki mai, kua ātete rānei ki te mate pukupuku (r/r LBCL). Ko te rangahau, te whanaketanga, me te whakaputanga o HICARA e whakawhirinaki katoa ana ki te hoahoa ngota motuhake a Hrain Biotechnology, te pūnaha kounga tukanga kua whakatū motuhake, me te tūāpapa whakaputa nui, kati. Mā tēnei whakatutukitanga ka tutuki te whakawhanaungatanga katoa o te whanaketanga me te whakaputanga pūtau CAR-T, ka pakaruhia ngā mana whakahaere hangarau o tāwāhi. He mea nui, ko HICARA te hua CAR-T tuatahi kua whakaaetia i roto i te motu ki te tango i tētahi tukanga kawe huaketo raina pūtau pumau.

E ai ki ngā hua o te whakamātautau Wāhanga II HRAIN01-NHL01-II (NCT05436223) i tukuna i te Hui-ā-Tau o te American Association for Cancer Research (AACR) 2024, i whakaatu a HICARA i ngā urupare whai hua ki ngā tūroro e pāngia ana e te lymphoma non-Hodgkin kua hoki whakamuri/aukati.

Ngā Hua: I te 16 o Mei, 2023, e 81 ngā tūroro R/R NHL me te ECOG 0-1 i te tīmatanga i whiwhi i te werohanga HR001 mai i te whare hanga o Jinshan [51.9% tāne; te pakeke toharite 53.4 tau (te whānuitanga 23~74); 3.7% CD19 kore; 91.4% lymphoma pūtau-B nui horapa; 79.0% III-IV o te whakarōpūtanga Ann Arbor, Lugano rānei] me te aroturukitanga toharite o te 160 rā (te whānuitanga 7 ki te 454). Ko te wā toharite ki te urupare pai rawa atu he 30 rā (te whānuitanga 28-358). Ko te reiti urupare whāinga pai rawa atu (ORR) mō ngā marama 3, marama 6, ko te 53.1% (95% CI: 41.7-64.3), 45.7% (95% CI: 34.6-57.1) me te 74.1% (95% CI: 63.1-83.2) ia. Ko te reiti urupare katoa pai rawa atu (CRR) mō ngā marama 3, marama 6, ko te 32.1% (95% CI: 22.2-43.4), 29.6% (95% CI: 20.0-40.8) me te 49.4% (95% CI: 38.1-60.7) ia. Ko te roanga waenga o te urupare (DOR) me te oranga kore-haere (PFS) ko te 339 rā (95% CI: 149-NE) me te 176 rā (95% CI: 91-NE) ia. Kāore i tutuki te oranga whānui (OS). Ko ngā pānga kino (AE) e pā ana ki te maimoatanga i puta i roto i te pūnaha toto. I puta te mate tuku cytokine (CRS) i roto i te 95.1% o ngā tūroro, me te ≥3 taumata CRS i kitea i roto i te 3.7% o ngā tūroro. I puta te mate neurotoxicity e pā ana ki ngā pūtau pānga ārai mate (ICANS) i roto i te 8.6% o ngā tūroro, kāore he ≥3 taumata ICANS i pūrongohia. Ko te mate e pā ana ki te maimoatanga he 1.2%. Ko te wā toharite ki te whakawhānui i te tihi pūtau-T CAR he 240 hāora (120~672) i muri i te werohanga, ko te whakawhānui mōrahi toharite (Cmax) he 17413.9 kape/μg DNA (124.9~136382.2), me te AUC toharite._{0-28 rā}he 3201014.0 tārua/μg DNA (205082.8~18400016.2). I kitea he pai ngā whakamātautau mō te paturopi ārai-tarukino (ADA) i roto i te 14.8% o ngā tūroro, ā, i kitea he pai ngā whakamātautau paturopi ārai-whakakore (Nab) i roto i te 3.7% o ngā tūroro. I roto i ngā tūroro Nab-pai, i puritia te urupare katoa tae noa ki te whai i te whakamātautau.

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