I te 7 o Ākuhata, i panuitia e te Center for Drug Assessment (CDE) o te National Medical Products Administration (NMPA) kua whakaarohia te werohanga PA3-17 kia whakaurua ki te tohu whakaora hou, e whakaarohia ana mō te maimoatanga o ngā tūroro pakeke e pāngia ana e te relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL).
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
Īmēra：myimmnet@163.com
Ko ngā tūroro e pāngia ana e te mate pukupuku toto/lymphoma T-lymphoblastic kua hoki anō/ātete ki te mate (r/r T-ALL/LBL) ka kitea i roto i te haumanu mā te tere o te whanaketanga o te mate, te kino o te matapae me te kore o ngā whiringa rongoā. I tēnei wā, ko Nailabine anake i whakaaetia e te FDA i te tau 2005 hei rongoā mō ngā tūroro T-ALL/LBL kāore i aro ki te iti rawa e rua ngā tikanga chemotherapy, i hoki anō rānei i muri i te maimoatanga, me te ORR o te 31% me te CR o te 23%. Nō reira, me tere te whakawhanake i ētahi atu tikanga whai hua. Haunga tōna whakaaturanga i roto i ngā pūtau T me te NK noa, me te kore whakaaturanga i roto i ētahi atu pūtau kiko, he nui te whakaaturanga o te CD7 i roto i ngā pūtau T-ALL/LBL. Nō reira, e kiia ana ko te CD7 te whāinga pea mō te whanaketanga o te rongoā CAR-T mō te T-ALL/LBL. Heoi, ko te wero ko te karo i te whakamate i te whanaunga i puta mai i te whakaaturanga o te CD7 i roto i ngā pūtau T. I whakawhanakehia e ngā kairangahau he werohanga pūtau CAR-T i runga i ngā nano antibody CD7, ko te werohanga PA3-17 te ingoa, mā te aukati i te whakaaturanga o te ngota CD7 i runga i te mata o ngā pūtau-T mā te aukati whakaaturanga pūmua anti-CD7 (PEBL).
I whakaaturia ngā raraunga whai muri mō te wā roa mai i te whakamātautau haumanu Wāhanga I o te werohanga PA3-17 mō te maimoatanga o te mate pukupuku toto/lymphoma lymphoblastic acute pūtau-T kua hoki mai/aukati (R/R T-ALL/LBL) i te huihuinga mātauranga whai mana o te ao EHA 2025.
I te 19 o Pēpuere, 2025, e 13 ngā tūroro katoa i whakaurua (3 ngā tūroro i te horomanga 1, 2, 3 rōpū, 4 ngā tūroro i te rōpū RP2D), i whiwhi katoa rātou i te werohanga kotahi o te PA3-17, ā, i oti i a rātou te aromatawai i ngā paitini whakawhāiti horomanga (DLT) mō ngā rā 28. I whakatūria te RP2D i te 2×10⁶ CAR-T/kg i runga i te pharmacokinetics, te haumaru me te whai huatanga i tua atu i tēnei horomanga. Kāore i puta he DLT, ā, kāore i eke ki te horomanga manawanui mōrahi (MTD). Ko te auau o te mate tuku cytokine (CRS) he 84.6% (G3:23.1%, kāore he G4), ko te mate paitini neuro e pā ana ki ngā pūtau ārai mate (ICANS) i herea ki te G1-2 (15.4%). I whakaatuhia e ngā raraunga whai huatanga ko te reiti urupare whāinga pai rawa atu (ORR) ko te 84.6% (11/13) ā, 76.9% (10/13) i tutuki te murunga katoa/murunga katoa me te whakaoranga tatau kāore i oti (CR/CRi). He mea whakamiharo, 69.2% (9/13, 8 ngā tūroro CR) i pupuri i te urupare i te 3 marama, me te 50.0% (4/8) i pupuri i te CR>15 marama i muri i te werohanga me te kore he whakawhitinga pūtau take (SCT), ā, e rua o rātou i mau tonu ngā pūtau CAR-T i kitea i te 21 marama. He mea nui, ko tētahi tūroro i mua i te maimoatanga nui [Te Whakawhitinga Pūtau Take Hematopoietic (HSCT) o mua, he mate nui >7cm] i eke ki te CR i te rā 28 me te HSCT tuarua i te 6 marama.
I whakaatuhia e te werohanga PA3-17 te manawanui pai, te kaha haumanu hohonu me te pumau i roto i ngā tūroro T-ALL/LBL r/r i mua i te maimoatanga nui, me te 50% o ngā tūroro CR i ora tonu, kāore rānei e whanake haere i te 1 tau.
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: 13 o Ākuhata 2025