Ka lāʻau lapaʻau TIL (GT101)

He lāʻau lapaʻau cell autologous ʻo GT101 i hana ʻia me ka TIL i hoʻonui ʻia a hoʻoulu hou ʻia mai ka puʻupuʻu ponoʻī o ka mea maʻi. Hoʻokele ʻia ka lāʻau lapaʻau ma ka ʻohi ʻana i nā ʻiʻo puʻupuʻu mai nā mea maʻi a me ka unuhi ʻana i ka TIL. A laila e hoʻonui ʻia ka TIL i unuhi ʻia me ka hoʻohana ʻana i ka paepae hana ponoʻī a Grit Bio ʻo StemTexp® a hoʻokomo hou ʻia i loko o nā mea maʻi e hakakā i nā puʻupuʻu.

Ma ka makahiki 2024Hālāwai Makahiki o ka ʻAhahui ʻAmelika o ka Oncology Lapaʻau (ASCO),ua hōʻike ʻia ka ʻikepili ma luna o 14 mau maʻi puʻupuʻu paʻa e komo ana i ka noiʻi GT101. Ua hoʻolālā ʻia ka hoʻokolohua me ka hopena mua ma ka loiloi ʻana i ka DLT a me ke ʻano o ka palekana o GT101 i nā maʻi puʻupuʻu paʻa i ana ʻia e ka hanana o nā hanana ʻino emergency treatment-emergent (TEAEs) Grade ≥ 3. ʻO nā hopena lua e loiloi i nā palena pono e pili ana i ka helu pane holoʻokoʻa (ORR), ka helu kaohi maʻi (DCR), ke ola ʻole o ka holomua (PFS), ka lōʻihi o ka pane (DOR), a me ke ola holoʻokoʻa (OS) e like me RECIST v1.1.

Nā Hualoaʻa: Ma ka lā 10 o Nowemapa, 2023, ua loaʻa i kahi hui o 14 mau maʻi ka lāʻau lapaʻau me ka makahiki waena o 46.9 a me ka waena o 2.6 mau laina o nā lāʻau lapaʻau mua. Ma hope o kahi lymphodepletion maʻamau e pili ana iā FC, ua loaʻa i nā maʻi ka hoʻokomo ʻana o GT101 ma nā dosis ≥ 5 × 109 mau cell me ka dosis waena o 3.7 × 1010 mau cell, a ukali ʻia e ka hoʻokele IL-2 kiʻekiʻe. ʻO ka hapa nui o nā AE Grade ≥ 3 i ʻike ʻia e pili ana i ka regimen hoʻomaʻamaʻa FC a me IL-2, me ka emi ʻana o ka helu lymphocyte, ka emi ʻana o ka helu o nā cell koko keʻokeʻo, ka emi ʻana o ka helu neutrophil, ka anemia, ka pyrexia a me ka emi ʻana o ka helu platelet. Ua hoʻōla ʻia ka hapa nui o kēia mau AE i loko o 14 mau lā, ʻoiai ua hoʻohaʻahaʻa ʻia kekahi mau mea i ≤ Grade 2 i loko o 4 mau pule. Ma waena o 14 mau maʻi i kākau inoa ʻia ma nā hōʻailona like ʻole (ka maʻi kanesa cell-mamaʻi liʻiliʻi, melanoma, ka maʻi kanesa cervical), ʻo ka ORR he 35.7%. ʻO ke kikoʻī, he 4 pts (28.6%) i loaʻa kahi pane hapa i hōʻoia ʻia (PR), 1 pt (7.1%) i loaʻa ka pane piha (CR), a he 8 pts (57.1%) i loaʻa ka maʻi paʻa (SD) ʻo ia kā lākou pane maikaʻi loa. Hoʻokahi pt i loaʻa ka holomua o ka maʻi i hōʻoia ʻole ʻia (PD). ʻIke ʻia, ma waena o 11/14 mau maʻi me ka maʻi ʻaʻai cervical, ʻo ka ORR he 45.5% (5/11) me 4 pts (36.4%) i loaʻa ka PR a me 1 pt (9.1%) i loaʻa ka CR. Ua ʻike ʻia ka kaohi ʻana o ka maʻi ma 10/11 pts (90.9%), a ʻo ka PFS waena he 4.2 mau mahina no kēia cohort. Ua hana ʻia ka mea maʻi CR i kahi hahai lōʻihi a ʻo ka lōʻihi o CR a me PFS (i manaʻo ʻia e Kaplan-Meier) he 24 pule a me 36 pule, kēlā me kēia. Ma hope o ka hoʻokomo ʻia ʻana o GT101, ua hoʻonui ikaika ʻia ke kele T i loko o ke koko peripheral o nā maʻi āpau me ka awelika Tmax 6.83 mau lā a me ka awelika 15.9 mau lā.

Nā Hopena: Ma ke aʻo ʻana o ka GT101 Phase 1, ʻaʻohe SAE a me DLT e pili ana i ka lāʻau lapaʻau i ʻike ʻia. I nā poʻe maʻi me nā ʻōpū paʻa holomua a metastatic paha i mālama mua ʻia, ua hōʻike ʻo GT101 i kahi ʻano palekana hiki ke hoʻokele ʻia ma lalo o ke kaʻina hana lapaʻau o ka lymphodepletion a me ka IL-2 kiʻekiʻe a me kahi ʻano lapaʻau maikaʻi, ʻoi aku hoʻi i ka maʻi ʻaʻai cervical, me kahi ORR hoʻoikaika a me ka lōʻihi o ka pane.

I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.

Helu Kelepona：4008803716

Email：myimmnet@163.com

Nā Kuhikuhi

1.https://www.grit-bio.com/newsinfo/4620292.html

2.https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2548