Ua hōʻoia ka Haʻawina Hou i ka Palekana a me ka Pono o ka CD19/CD20 CAR-T Therapy no r/r B-NHL
Ua paʻi ʻia kahi noiʻi hou ma Kokohōʻike i ka hoʻomohala holomua o ka prizloncabtagene autoloucel (prizlon-cel), kahi lāʻau lapaʻau CAR-T cell CD19/CD20 hou, no ka mālama ʻana i ka relapsed/refractory B-cell ʻO ka Lymphoma Non-Hodgkin (r/r B-NHL). ʻO ka hoʻokolohua, kahi haʻawina pae 1, multicenter, open-label i mālama ʻia ma Kina, hāʻawi i nā ʻikepili hoʻohiki e pili ana i ka palekana a me ka pono o kēia ʻano hana pālua.
I alakaʻi ʻia e kahi hui o nā mea noiʻi kaulana mai nā ʻoihana e like me ka Halemai Hoʻohui Mua o ke Kulanui ʻo Zhejiang a me ke Kulanui ʻo Tongji, ua kākau inoa ke aʻo ʻana i 48 mau maʻi me r/r B-NHL, ʻo ka hapa nui he nui Lymphoma Pūnaewele B (LBCL). Ua hana mua ʻia nā maʻi i ka awelika o ʻekolu laina o ka lāʻau lapaʻau. Ua loaʻa i nā mea komo kahi hoʻokomo hoʻokahi o ka prizlon-cel ma hope o ka chemotherapy lymphodepleting, me nā mahele e kū ana ma nā pae ʻekolu (DL1, DL2, a me DL3).
Nā ʻIke Koʻikoʻi:
- ʻIke Palekana: ʻAʻohe mea ʻawahia e kaupalena ana i ka lāʻau lapaʻau (DLT) i ʻike ʻia, a ua hōʻike ka lāʻau lapaʻau i nā hopena ʻaoʻao hiki ke hoʻokele ʻia. Ua ʻike ʻia ka maʻi hoʻokuʻu Cytokine (CRS) ma 93.8% o nā maʻi, ʻo ka hapa nui he papa 1-2, me hoʻokahi wale nō hihia papa 3. He mea kākaʻikahi a palupalu ka maʻi neurotoxicity pili i ka cell effector cell (ICANS), me ka ʻole o nā hanana papa 3 a ʻoi aku paha.
- Ka pono: Ua hoʻokō ʻia kahi helu pane holoʻokoʻa (ORR) o 91.5%, me ka helu pane piha (CR) o 85.1%. Ma waena o nā poʻe maʻi LBCL, ʻo nā helu ORR a me CR he 90.7% a me 86.0%, kēlā me kēia. ʻO ka mea kupaianaha, 48.9% o nā poʻe maʻi i mālama i ka CR ma ka nānā hope loa, me kekahi mau pane i ʻoi aku ma mua o ʻekolu mau makahiki.
- Nā Hopena Ola: Ua hōʻike nā kuhi a Kaplan-Meier i ka lōʻihi o ka pane ʻana (DOR) no 2 mau makahiki, ke ola ʻole me ka holomua ʻole (PFS), a me nā helu ola holoʻokoʻa (OS) o 66.0%, 62.6%, a me 76.5%, kēlā me kēia. I nā poʻe maʻi CR, ʻoi aku ke kiʻekiʻe o kēia mau helu.
Ua hōʻike ʻo Prizlon-cel i ka hoʻonui ikaika a me ke kūpaʻa lōʻihi, me ka manawa hoʻōla waena o nā cell B he 185 mau lā. Hoʻoponopono kāna hoʻolālā pālua i ka pakele ʻana o ka antigen, kahi ʻano kūʻē maʻamau i nā lāʻau lapaʻau CAR-T.