Ma ʻAukake 7, ua hoʻolaha ke Kikowaena no ka Loiloi Lāʻau Lapaʻau (CDE) o ka National Medical Products Administration (NMPA) ua hāpai ʻia ka inikini PA3-17 no ka hoʻokomo ʻia ʻana i loko o ka hoʻolālā lapaʻau holomua, i manaʻo ʻia no ka mālama ʻana i nā poʻe maʻi makua me ka relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL).
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
ʻIkepili WeChat: 17801183037
Leka uila:myimmnet@163.com
ʻO nā maʻi me ka relapsed/refractory T-lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL) e hōʻike ʻia ana ma ke ʻano lapaʻau e ka holomua wikiwiki o ka maʻi, ka prognosis maikaʻi ʻole a me ka nele o nā koho therapeutic. I kēia manawa, ʻo Nailabine wale nō i ʻae ʻia e ka FDA i ka makahiki 2005 no ka mālama ʻana i nā maʻi T-ALL/LBL i pane ʻole i ʻelua mau regimen chemotherapy a i ʻole relapsed ma hope o ka mālama ʻana, me ka ORR o 31% a me ka CR o 23%. No laila, aia kahi pono wikiwiki e hoʻomohala i nā ʻano hana kūpono ʻē aʻe. Ma waho aʻe o kona hōʻike ʻana i nā pūnaewele T a me NK maʻamau a me ka ʻole o ka hōʻike ʻana i nā pūnaewele ʻiʻo ʻē aʻe, ua hōʻike nui ʻia ʻo CD7 i nā pūnaewele T-ALL/LBL. No laila, ua manaʻo ʻia ʻo CD7 he pahuhopu kūpono no ka hoʻomohala ʻana o ka lāʻau lapaʻau CAR-T no T-ALL/LBL. Eia naʻe, ʻo ka pilikia, ʻo ia ka pale ʻana i ka fratricide i hoʻokumu ʻia e ka hōʻike ʻana o CD7 i nā pūnaewele T. Ua hoʻomohala nā kānaka noiʻi i kahi inikini pūnaewele CAR-T e pili ana i nā nano antibodies CD7, i kapa ʻia ʻo PA3-17 injection, ma ke ālai ʻana i ka hōʻike ʻana o ka molekala CD7 ma luna o ka ʻili o nā pūnaewele T ma o ka mea pale hōʻike protein anti-CD7 (PEBL).
Ua hōʻike ʻia nā ʻikepili hahai lōʻihi mai ka hoʻokolohua lapaʻau Phase I o ka inikini PA3-17 no ka mālama ʻana i ka relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) ma ka ʻaha kūkā hoʻonaʻauao honua EHA 2025.
Ma Pepeluali 19, 2025, ua kākau inoa ʻia he 13 mau maʻi (3 mau maʻi ma ka mahele lāʻau 1, 2, 3 hui, 4 mau maʻi ma ka hui RP2D), ua loaʻa iā lākou āpau kahi hoʻokomo hoʻokahi o PA3-17 a ua hoʻopau i kahi loiloi 28 lā e kaupalena ana i nā toxicities (DLT). Ua hoʻokumu ʻia ʻo RP2D ma 2 × 10⁶ CAR-T/kg ma muli o ka pharmacokinetics, ka palekana a me ka pono ma mua o kēia mahele lāʻau. ʻAʻohe DLT i hana ʻia a ʻaʻole i hiki i ka mahele lāʻau i ʻae ʻia (MTD). ʻO ka hanana o ka cytokine release syndrome (CRS) he 84.6% (G3: 23.1%, ʻaʻohe G4), ʻoiai ua kaupalena ʻia ka immune effector cell-associated neurotoxicity syndrome (ICANS) i G1-2 (15.4%). Ua hōʻike ʻia ka ʻikepili pono ʻana ʻo ka helu pane kūpono maikaʻi loa (ORR) he 84.6% (11/13) a he 76.9% (10/13) i loaʻa ka hoʻomaha piha/hoʻomaha piha me ka hoʻōla helu piha ʻole (CR/CRi). ʻO ka mea kupanaha, 69.2% (9/13, 8 mau maʻi CR) i mālama i ka pane ma 3 mahina, me 50.0% (4/8) e mālama ana i ka CR> 15 mau mahina ma hope o ka hoʻokomo ʻana me ka ʻole o ka hoʻoili ʻana o nā cell stem (SCT), a ʻelua o lākou i loaʻa nā cell CAR-T i ʻike ʻia ma 21 mau mahina. ʻO ka mea nui, ua loaʻa i kahi maʻi i mālama nui ʻia [ma mua o ka Hematopoietic Stem Cell Transplantation (HSCT), maʻi nui> 7cm] ka CR i ka lā 28 a me ka lua o ka HSCT ma 6 mau mahina.
Ua hōʻike ka inikini PA3-17 i ka hoʻomanawanui maikaʻi, ka hana lapaʻau koʻikoʻi a hoʻomau ʻia i nā poʻe maʻi r/r T-ALL/LBL i mālama nui ʻia, me 50% o nā poʻe maʻi CR e ola ana a/a ʻaʻohe holomua ma 1 makahiki.
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
ʻIkepili WeChat: 17801183037
Email：myimmnet@163.com
Ka manawa hoʻouna: Aug-13-2025