ʻO ka satricabtagene autoleucel（Satri-cel, CT041) he moho huahana CAR T-cell autologous e kūʻē i ka protein Claudin18.2 nona ka hiki ke lilo i mua ma ka papa honua. Hoʻopaʻa ʻo Satri-cel i nā puʻupuʻu paʻa Claudin18.2 maikaʻi me ka nānā nui ʻana i ka maʻi ʻaʻai gastric/gastroesophageal junction cancer (GC/GEJ) a me ka maʻi ʻaʻai pancreatic (PC).
Ua paʻi ʻia nā hopena hope loa o ka hoʻokolohua i hoʻomaka ʻia e ka mea noiʻi ʻo CT041-CG4006 (NCT03874897) o satricabtagene autoleucel ma Nature Medicine ma Iune 3, 2024.
He 98 mau maʻi i komo i ka hoʻokolohua, a ua hōʻike nā hopena ua like ka nui o ka helu kaohi maʻi (DCR) me 91.8%, ua loaʻa i 38 mau maʻi ke kala ʻana, ʻo ka nui o ke kala ʻana he 38.8%, ʻo ka awelika o ke ola manuahi holomua (PFS) he 4.4 mau mahina, ʻo ka awelika o ke ola holoʻokoʻa (OS) he 8.8 mau mahina, a ʻo ka awelika o ka lōʻihi o ke kala ʻana (mDOR) he 6.4 mau mahina. Ma waena o nā maʻi lesion pahuhopu kumu he 90, ua loaʻa i 70 mau maʻi nā ʻano like ʻole o ka emi ʻana o ka puʻupuʻu.
Ma waena o 51 mau maʻi kanesa ʻōpū i mālama ʻia me ka monotherapy me Satri-cel, ʻo ka nui o ka hoʻomalu ʻana i ka maʻi ua like me 96.1% (49), a ʻo ka nui o ka pane holoʻokoʻa he 54.9% (28). Ma waena o lākou, ua loaʻa i 27 mau maʻi ka pane hapa (PR), 1 maʻi i loaʻa ka pane piha (CR), a ʻo ka lōʻihi waena o ka pane (mDOR) he 6.4 mau mahina.
Hopena
Hōʻike ʻo Satri-cel i ka hiki ke hoʻōla me kahi ʻaoʻao palekana e hiki ke hoʻokele ʻia i nā poʻe maʻi me ka maʻi ʻōpū holomua CLDN18.2-positive.
Ma ka lā 9 o Kepakemapa, 2023, ua paʻi ʻia ʻelua mau hihia o ka mālama ʻana i ka maʻi kanesa pancreatic metastatic me CARsgen's CT041, kahi Claudin (CLDN) 18.2 CAR T-cell Therapy hou, ma ka Journal of Hematology & Oncology i kapa ʻia ʻo "CT041 CAR T cell therapy for Claudin18.2 positive metastatic pancreatic cancer".
No ka hihia 1, ua ʻike ʻia kahi wahine 58 makahiki me ka maʻi ʻaʻai pancreatic me ka metastasis o nā māmā a me nā lymph nodes. ʻAʻole i hāʻule ka laina mua nab-paclitaxel me ka gemcitabine a me ka laina lua irinotecan-liposome me ka 5-flurouracil ma mua o kona kākau inoa ʻia ʻana i ka hoʻokolohua lapaʻau CT041, ma hope o ka hōʻoia ʻana i ka hōʻike ʻana o CLDN18.2 ma ke ʻano he 2+/70%. Ma hope o ka lymphodepletion i haku ʻia me fludarabine, cyclophosphamide, a me nab-paclitaxel, kahi mahele CT041 o 250 × 106ua hāʻawi ʻia nā pūnaewele i ka mea maʻi i Kepakemapa 2021. Ua kū mai ka maʻi hoʻokuʻu cytokine (CRS) papa 2, kahi i kāohi ʻia ma hope e tocilizumab. Ua hoʻokō ʻia ka pane hapa (PR) e like me RECIST v1.1, me ka emi nui ʻana o ka metastasis māmā.
No ka hihia 2, ua ʻike ʻia kahi wahine 75 makahiki he maʻi ʻaʻai pancreatic pT2N0 ma hope o kona hana ʻana i ke ʻoki kino i Mei 2019. Ua ʻike ʻia ka metastasis māmā ma hope o 5 mau mahina i ka wā o ka hahai ʻana ma hope o ke ʻoki kino. Ua hāʻawi ʻia ka monotherapy S-1 ma ke ʻano he chemotherapy laina mua e hoʻomaka ana mai Dekemaba 2019. I ka wā o ka radiation palliative ma ka wahi ʻoki kino, ua ʻike ʻia ka holomua o ka tumor i loko o ka māmā. ʻOiai ua hoʻoholo ʻia ka hōʻike ʻana o CLDN18.2 he 3+/60%, ua kākau inoa ʻia ka mea maʻi i ka hoʻokolohua lapaʻau CT041. Ma hope o ka loaʻa ʻana o ka lymphodepletion i loko o ka fludarabine, cyclophosphamide a me nab-paclitaxel, ua hoʻokomo ʻia ka mea maʻi me kahi mahele CT041 o 250 × 10.6nā pūnaewele i Iulai 2021. Ua loaʻa i ka mea maʻi ka CRS papa 2, kahi i kāohi hou ʻia me ka tocilizumab. Ua hōʻea ʻia ka PR mai ka loiloi mua ʻana he 4 mau pule ma hope o ka hoʻokomo ʻana. Ma hope iho, ua nalowale nā ʻeha i manaʻo ʻia o ka metastasis māmā a ua loaʻa ka pane piha. Ua mālama maikaʻi ʻia ka puʻupuʻu a hiki i ka hahai hope loa i Iulai 2023. Ua hōʻike ka helu kope CAR koko peripheral CLDN18.2 i nā maʻi ʻelua i ka piʻi wikiwiki ʻana ma hope o ka hoʻokomo ʻana, e piʻi ana i loko o 2 mau pule. I ka manawa like, ua hōʻike nā hopena hoʻokaʻawale pūnaewele fluorescence-activated i ka piʻi ʻana o nā pūnaewele CD8 T koko peripheral a me nā pūnaewele Treg, me ka emi ʻana o nā pūnaewele CD4 T a me nā pūnaewele B. Ua hōʻike kēia mau hoʻololi i nā phenotypes cell immune i ka hoʻomau nui ʻana i hoʻohālikelike ʻia me nā hoʻololi i nā pae cytokine.
I kēia manawa, nui nā hoʻokolohua lapaʻau CAR-T ʻē aʻe ma Kina, a ke ʻimi nei lākou i nā maʻi. No ke kūkākūkā ʻana i nā lāʻau lapaʻau hou a me nā ʻenehana, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
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Nā Kuhikuhi
1.https://www.carsgen.com/en/news/carsgen-presents-updated-results-on-satri-cel-in-nature-medicine-and-at-2024-asco/
2.https://www.nature.com/articles/s41591-024-03037-z
3.https://www.carsgen.com/media/fooloi3a/ct041-cg4006-asco-2024_v3-0_20240603.pdf
4.https://jhoonline.biomedcentral.com/articles/10.1186/s13045-023-01491-9
Ka manawa hoʻouna: Nov-21-2024