I te marama o Ākuhata 2025, i whakamanahia e te Center for Drug Evaluation (CDE) o te National Medical Products Administration (NMPA) te Breakthrough Therapy Designation ki a Ina-cel, he rongoā pūtau CAR-T hou i whakahaerehia e te CD19 i whakawhanakehia motuhaketia e Juventas, hei rongoā i ngā tūroro tamariki me te mate pukupuku toto lymphoblastic acute pūtau-B kua hoki mai, kua uaua rānei te rongoā (r/r B-ALL).
I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.
Tau Waea：4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
Ko te Inaticabtagene autoleucel (Inati-cel) he hua pūtau-T CD19-motuhake, kei roto ko te CD19 scFv i ahu mai i te clone HI19α me te rohe costimulatory 4-1BB/CD3-ζ, i whakaaetia i Haina mō ngā tūroro pakeke me te relapsed, te refractory B-acute lymphoblastic leukemia (r/r B-ALL) rānei i te Whiringa-ā-rangi 2023.
TeHui-ā-Tau a te ASCO 2025 pūrongo te rangahau ao tūturu maha-pokapū, kore-wawao (NCT06450067) hei aromatawai i te Inati-cel mō ngā tūroro pakeke B-ALL. I waenganui i te 20 o Noema, 2023, me te 13 o Noema, 2024, e 62 ngā tūroro i whiwhi i te Inati-cel, ā, i taea te aromatawai. Ko te tau toharite he 37.5 (awhe, 14-76) tau, me te 13 ngā tūroro e ≥60 tau te pakeke. I te tirotiro, 16 ngā take i hoki anō i muri i te whakawhitinga pūtau take hematopoietic (HSCT), 4 ngā take he ātete tuatahi, ā, neke atu i te 70% o ngā tūroro he mate ira tino mōrearea. Ko te horopeta werohanga toharite he 0.60 (awhe: 0.46-0.9) ×10Ngā pūtau ora 8CAR-T.
Ngā Hua: Ko ngā raraunga i te 30 o Hakihea, 2024, me te roanga o te aroturukitanga toharite o te 3.8 marama (awhe: 0.5–12.4 marama), 89.5% i whiwhi i te ORR MRD-kino i muri i te Inati-cel i roto i ngā tūroro r/r, tae atu ki te 31 me te CR me te 3 me te CRi (ripanga 1). E iwa ngā tūroro he MRD-pai i te tirotiro, ko te reiti MRD-kino i eke ki te 100% i muri i te Inati-cel. I muri i te Inati-cel, 26 ngā tūroro i kitea ngā hua MRD mā te q-PCR, ā, 92.3% i whiwhi hua kino. I muri i te whakatutukitanga o te CR/CRi, 4 ngā tūroro i whai allo-HSCT i muri mai i te wā e murua ana. Kāore anō kia eke te DOR, te OS me te RFS toharite me te kore e aukati i ngā tūroro i te allo-HSCT i muri mai. I roto i ngā tūroro ka taea te arotake, ko ngā reiti RFS me te DOR 1-tau he 76.2% me te 74.1%, ia. Tokowhitu ngā tūroro i pāngia e te hokinga mai o te mate, tae atu ki te 3 ngā hokinga mai o te CD19+, te 2 ngā hokinga mai o te CD19-, me te 2 kāore i te mārama te tūnga o te CD19. He mea nui kia mōhiotia i roto i te 6 ngā take o te mate extramedullary, e 4 ngā take i whai hua, engari e 2 ngā take i hoki mai anō i roto i te 3 marama i muri i te Inati-cel. I ora katoa ngā tūroro i whiwhi i te werohanga Inati-cel, engari kotahi te mate i puta mai i te whanaketanga o te mate. Ko ngā pānga kino tino kitea (AE) ko te cytokine release syndrome (CRS) me te immune effector cell-associated neurotoxicity syndrome (ICANS). E rima tekau mā tahi ōrau o ngā tūroro i pāngia e te CRS, engari ko te CRS me te ICANS taumata 3, teitei ake rānei, i puta noa i te 3.2% me te 1.6% o ngā tūroro; i ora katoa ngā tūroro me te kore he pānga kino, kāore he mate e pā ana ki te AE.
Ko te whakamahinga o Inati-cel i te ao tūturu e whakaatu ana i te ORR MRD-kino teitei i roto i te B-ALL pakeke. I taea te whakahaere i te kōtaha haumaru, me te iti o te auau o te CRS ≥3 me te ICANS i te ao tūturu. Ka whakaatuhia ngā raraunga aroturuki roa ake.
I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.
Tau Waea：4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
Wā tuku: 26 o Ākuhata-2025