I te 21 o Pēpuere, 2025, i whakawhiwhia e te Center for Drug Assessment (CDE) o te National Medical Products Administration (NMPA) te Breakthrough Therapy Designation (BTD) mō Satri-cel（CT041）(he hua pūtau-T CAR autologous hei ārai i a Claudin18.2), mō te adenocarcinoma gastric/esophagogastric junction (G/GEJ) matatau me te whakaaturanga pai o Claudin18.2 (CLDN18.2) kua rahua i mua i te maimoatanga raina tuarua.
Kua whakaputaina te whakamātautau i tīmatahia e te kairangahau CT041-CG4006 (NCT03874897) o te satricabtagene autoleucel (“satri-cel”, CT041) (he hua pūtau-T CAR autologous hei patu i a Claudin18.2) i roto i te Nature Medicine i te 3 o Hune, 2024.
I roto i tēnei whakamātautau, i whakaurua he wāhanga whakanui horopeta (n = 15) me te wāhanga whakawhānui horopeta i roto i ngā rōpū rerekē e whā (katoa n = 83): rōpū 1, satri-cel monotherapy i roto i te 61 tūroro me ngā mate pukupuku puku paerewa ātete-kimiora; rōpū 2, satri-cel me te rongoā anti-PD-1 i roto i te 15 tūroro me ngā mate pukupuku puku paerewa ātete-kimiora; rōpū 3, satri-cel hei maimoatanga raupapa i muri i te rongoā raina tuatahi i roto i te rima tūroro me ngā mate pukupuku puku; me te rōpū 4, satri-cel monotherapy i roto i te rua tūroro me te mate pukupuku puku ātete-antibodi monoclonal anti-CLDN18.2. Ko te mutunga tuatahi ko te haumaru; ko ngā mutunga tuarua ko te whai huatanga, te pharmacokinetics me te immunogenicity. I whiwhi katoa i te 98 tūroro i te werohanga satri-cel, i roto i a rātou 89 i horopetahia ki te 2.5 × 108, ono ki te 3.75 × 108 me te toru ki te 5.0 × 108 CAR T cells. Ko te roanga o te aroturukitanga waenga he 32.4 marama (95% te wā whakawhirinaki (CI): 27.3, 36.5) mai i te apheresis. Kāore i puta he pūrongo mō ngā paitini whakawhāiti horopeta, ngā mate e pā ana ki te maimoatanga, te mate neurotoxicity e pā ana ki ngā pūtau ārai mate rānei. I puta te mate tukunga cytokine i roto i te 96.9% o ngā tūroro, i whakarōpūtia katoa hei taumata 1–2. I kitea ngā whara o te mucosal puku i roto i ngā tūroro e waru (8.2%). Ko te reiti urupare whānui me te reiti whakahaere mate i roto i ngā tūroro 98 katoa he 38.8% me te 91.8%, ia, ā, ko te oranga kore-haere whakamua me te oranga whānui he 4.4 marama (95% CI: 3.7, 6.6) me te 8.8 marama (95% CI: 7.1, 10.2), ia. E whakaatu ana a Satri-cel i te kaha rongoā me te kōtaha haumaru ka taea te whakahaere i roto i ngā tūroro he mate pukupuku puku matatau CLDN18.2-pai.
Mō Satri-cel
He hua pūtau-T CAR autologous a Satri-cel hei ārai i te pūmua Claudin18.2, ā, he pūmanawa tōna hei tuatahi i roto i te ao. Ko te arotahi a Satri-cel ki te maimoatanga o ngā pukupuku totoka Claudin18.2 pai me te arotahi matua ki te mate pukupuku puku/mate pukupuku hononga gastroesophageal (GC/GEJ) me te mate pukupuku repeure (PC). Kei roto i ngā whakamātautau kei te haere tonu ko ngā whakamātautau i tīmatahia e te kairangahau (CT041-CG4006, NCT03874897), he whakamātautau haumanu Wāhanga II whakaū mō te GC/GEJ matatau i Haina (CT041-ST-01, NCT04581473), he whakamātautau haumanu Wāhanga I mō te rongoā PC adjuvant i Haina (CT041-ST-05, NCT05911217), me te whakamātautau haumanu Wāhanga 1b/2 mō te adenocarcinoma puku, pancreatic rānei matatau i Amerika Te Raki (CT041-ST-02, NCT04404595). I whakawhiwhia a Satri-cel ki te tohu Whakaora Rongoā Matatau (RMAT) e te US FDA mō te maimoatanga o te GC/GEJ matatau me ngā pukupuku Claudin18.2-pai i te marama o Hanuere 2022, ā, i whakawhiwhia hoki ia ki te tohu PRIME e te EMA mō te maimoatanga o te mate pukupuku puku matatau i te marama o Noema 2021. I whiwhi a Satri-cel i te tohu Orphan Drug mai i te US FDA i te tau 2020 mō te maimoatanga o te GC/GEJ me te tohu Orphan Medicinal Product mai i te EMA i te tau 2021 mō te maimoatanga o te mate pukupuku puku matatau.
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.
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Ngā Tohutoro
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
Te wā tuku: 27-Pepuere-2025