ʻO Glioblastoma Multiforme (GBM) kekahi o nā maʻi kanesa make loa, a aneane pau nā maʻi e ʻike hou ana ma muli o ke kūlana mālama o kēia manawa no ka GBM i ʻike hou ʻia. Hōʻike ka GBM hou (rGBM) i kahi ola waena ma lalo o 8 mau mahina me nā koho lapaʻau palena.
ʻO TX103 kahi lāʻau lapaʻau cell CAR-T e kuhikuhi ana iā B7-H3, i hoʻomohala kūʻokoʻa ʻia a ʻae ʻia me nā palapala Sila Nui Kina a me ka honua. Ua hōʻike ʻia nā hopena lapaʻau mua o ka mālama ʻana iā TX103 no nā gliomas hou i ka American Society of Clinical Oncology Annual Meeting (ASCO) i ka makahiki 2024.（NCT05241392）.
Nā Hana: He haʻawina hāmama kēia, hoʻokahi lima, "3+3" dose-piscaling a me nā dose he nui. ʻO ka pahuhopu nui ka loiloi ʻana i ka palekana a me ka nui o ka dose i ʻae ʻia. ʻO nā pahuhopu lua e pili ana i nā hopena ola, nā pane ʻana o ka puʻupuʻu, nā pane immunological, a me nā palena pharmacokinetic. Ua kākau inoa ʻia nā maʻi mai 18 a 75 mau makahiki me ka hoʻihoʻi hou ʻana i hōʻoia ʻia e ka scan kiʻi a me ka hōʻike ʻana o B7-H3 >= 30% e ka loiloi immunohistochemistry. Ua lawelawe ʻia ʻo TX103 intracavity a/a i ʻole intraventricularly i nā maʻi ma o kahi waihona Ommaya. Ua hāʻawi ʻia ʻo TX103 i kēlā me kēia pule i kēlā me kēia pōʻaiapuni ma nā pae dose 1, 2, a me 3 (20, 60, 150 miliona mau cell, kēlā me kēia), me ʻehā mau pōʻaiapuni ma ke ʻano he papa hoʻokahi.
Nā Hualoaʻa: Ma waena o Malaki 2022 a me Ianuali 2024, ua loaʻa i nā maʻi he 13 ma ka liʻiliʻi hoʻokahi infusion intracranial o TX103, me 3, 4, a me 6 mau maʻi ma nā pae mahele 1, 2, a me 3, kēlā me kēia. ʻO ka helu waena o nā pōʻaiapuni infusion he 4 (Min, Max 1,9). Ua hoʻokomo ʻia nā maʻi āpau i ka loiloi palekana, e hōʻike ana ʻaʻohe ʻawaʻawa palena mahele a i ʻole ka make e pili ana i ka lāʻau CAR-T. Ua loaʻa i nā maʻi āpau ma ka liʻiliʻi hoʻokahi hanana ʻino (AE), a ʻo nā AE e pili ana i ka lāʻau (TRAE) i komo pū me ka cytokine release syndrome, ka hoʻonui ʻia o ke kaomi intracranial (ICP), ka ʻeha poʻo, ka maʻi epilepsy, ka emi ʻana o ka ʻike, ka luaʻi ʻana, a me ka pyrexia. ʻO ka hapa nui o nā TRAE he papa 1-2, ʻoiai ua ʻike ʻia ʻekolu mau TRAE papa-3: hoʻokahi hihia o ka hoʻonui ʻia o ka ICP ma ka pae mahele 2, hoʻokahi hihia o ka maʻi epilepsy, a me kekahi hihia o ka emi ʻana o ka ʻike ma ka pae mahele 3. I Ianuali 2024, ʻeono mau maʻi mai nā pae mahele 1 a me 2 i kūpono no ka loiloi ola 12 mahina; ʻO ka helu ola holoʻokoʻa (OS) 12 mahina he 83.3% (95% CI: 58.3% ~ 100%), a ʻo ka OS waena he 20.3 mo (95% CI: 20.3 ~ ʻaʻole hiki). ʻElua o nā maʻi ʻekolu mai ka pae mahele 2 i loaʻa nā pane hapa a me nā pane piha, kēlā me kēia. Ma hope o ka hoʻokele ʻana o CAR-T, ua ʻike ʻia nā piʻi nui o nā cytokines, me IL-6 a me IFN-γ, a me nā helu kope kiʻekiʻe o ka gene CAR i loko o ka wai cerebrospinal, ʻoiai ua ʻike ʻia nā piʻi liʻiliʻi wale nō i loko o ke koko peripheral.
Nā Hopena: Ma kēia hoʻokolohua, ua manaʻo ʻia he palekana a ʻae ʻia ka mālama ʻana iā rGBM me TX103. Kākoʻo kēia mau hopena waena i ka noiʻi hou aku e hoʻohana ana iā TX103 e hoʻonui i nā hopena ola i nā poʻe maʻi me rGBM.
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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Ka manawa hoʻouna: Dec-09-2024