Ma Iulai 30, ua ʻāpono kūhelu ka National Medical Products Administration (NMPA) i ke kūʻai aku ʻana o HICARA no ka mālama ʻana i nā poʻe maʻi makua me ka lymphoma B-cell nui i hoʻihoʻi ʻia a i ʻole refractory (r/r LBCL) i loaʻa i ʻelua a ʻoi aku paha laina o ka lāʻau lapaʻau systemic. Hoʻokomo pū kēia me ka lymphoma B-cell nui diffuse, ʻaʻole i kuhikuhi ʻia (DLBCL, NOS); lymphoma B-cell nui diffuse i hoʻololi ʻia mai ka lymphoma follicular; lymphoma B-cell kiʻekiʻe me nā hoʻonohonoho hou ʻana o MYC a me BCL2; a me ka lymphoma B-cell kiʻekiʻe, ʻaʻole i kuhikuhi ʻia (HGBL, NOS).
ʻO kēia ka huahana CD19 CAR-T mua loa i hoʻomohala piha ʻia ma Kina e kuhikuhi pono ana i ka lymphoma nui B-cell i hoʻihoʻi ʻia a paʻakikī paha (r/r LBCL). ʻO ka noiʻi, ka hoʻomohala ʻana, a me ka hana ʻana o HICARA e hilinaʻi piha ana i ka hoʻolālā molekala ponoʻī a Hrain Biotechnology, ka ʻōnaehana maikaʻi o ke kaʻina hana i hoʻokumu kūʻokoʻa ʻia, a me ka paepae hana pani ʻia a nui. Hoʻokō kēia hoʻokō i ka hoʻokō piha ʻana o ka hoʻomohala ʻana a me ka hana ʻana o nā cell CAR-T, e uhaki ana i nā monopolies ʻenehana haole. ʻO ka mea nui, ʻo HICARA ka huahana CAR-T mua i ʻae ʻia ma ka home e hoʻohana i kahi kaʻina hana vector viral cell line paʻa.
Wahi a nā hopena o ka hoʻokolohua Phase II HRAIN01-NHL01-II (NCT05436223) i hōʻike ʻia i ka wā o ka Hālāwai Makahiki 2024 ʻAmelika Hui Pū ʻIa no ka Noiʻi ʻAna i ke Kanesa (AACR), ua hōʻike ʻo HICARA i nā pane kūpono i nā poʻe maʻi me ka lymphoma non-Hodgkin i hoʻihoʻi ʻia/pale ʻole.
Nā Hualoaʻa: Ma ka lā 16 o Mei, 2023, ua loaʻa i nā maʻi R/R NHL 81 me ECOG 0-1 ma ka hoʻomaka ʻana ka infusion HR001 mai ka hale hana ʻo Jinshan [51.9% kāne; makahiki waena 53.4 mau makahiki (pae 23~74); 3.7% CD19 maikaʻi ʻole; 91.4% diffuse large B-cell lymphoma; 79.0% III-IV o ka hoʻokaʻawale ʻana o Ann Arbor a i ʻole Lugano] me ka hahai waena o 160 mau lā (pae 7 a 454). ʻO ka manawa waena i ka pane maikaʻi loa he 30 mau lā (pae 28-358). ʻO ka helu pane kūpono maikaʻi loa (ORR) no 3 mahina, 6 mahina he 53.1% (95% CI: 41.7-64.3), 45.7% (95% CI: 34.6-57.1) a me 74.1% (95% CI: 63.1-83.2). ʻO ka helu pane piha maikaʻi loa no 3 mahina, 6 mahina he 32.1% (95% CI: 22.2-43.4), 29.6% (95% CI: 20.0-40.8) a me 49.4% (95% CI: 38.1-60.7). ʻO ka lōʻihi waena o ka pane (DOR) a me ke ola ʻole me ka holomua ʻole (PFS) he 339 mau lā (95% CI: 149-NE) a me 176 mau lā (95% CI: 91-NE). ʻAʻole i hiki ke ola holoʻokoʻa (OS). ʻO nā hanana ʻino e pili ana i ka lāʻau lapaʻau (AE) i hana ʻia ma ka ʻōnaehana hematologic. Ua ʻike ʻia ka cytokine release syndrome (CRS) ma 95.1% o nā maʻi, me ka ≥3 grade CRS i ʻike ʻia ma 3.7% o nā maʻi. Ua ʻike ʻia ka immuno effector cell-associated neurotoxicity syndrome (ICANS) ma 8.6% o nā maʻi, me ka ʻole o ka hōʻike ʻana o kekahi ≥ 3 grade ICANS. ʻO ka make e pili ana i ka lāʻau lapaʻau he 1.2%. ʻO ka manawa waena i ka hoʻonui ʻana o ka piko o ka CAR T-cell he 240 mau hola (120 ~ 672) ma hope o ka hoʻokomo ʻana, ʻo ka hoʻonui nui waena (Cmax) he 17413.9 kope / μg DNA (124.9 ~ 136382.2), a me ka AUC waena.0-28 lāhe 3201014.0 kope/μg DNA (205082.8~18400016.2). Ua ʻike ʻia nā hoʻokolohua maikaʻi no ka antibody anti-drug (ADA) ma 14.8% o nā maʻi, ʻoiai ua maikaʻi nā hoʻokolohua neutralizing antibody (Nab) ma 3.7% o nā maʻi. Ma waena o nā maʻi Nab-positive, ua mālama ʻia ka pane piha a hiki i ka hahai ʻana.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department. Phone Number：4008803716 WeChat ID: 17801183037 Email：myimmnet@163.com
Ka manawa hoʻouna: Iulai-31-2025