Thaum Lub Yim Hli 7, Lub Chaw Saib Xyuas Kev Tshuaj Xyuas Tshuaj (CDE) ntawm Lub Chaw Tswj Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau tshaj tawm tias kev txhaj tshuaj PA3-17 tau raug pom zoo kom suav nrog hauv kev kho mob tshiab, uas yog rau kev kho mob rau cov neeg laus uas muaj tus kab mob T-cell mob qog ntshav/lymphoma uas rov qab los/tsis ua haujlwm (r/r T-ALL/LBL).
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
Xov Tooj: 4008803716
WeChat ID: 17801183037
Email:myimmnet@163.com
Cov neeg mob uas muaj tus kab mob T-lymphoblastic leukemia/lymphoma rov qab los/tsis zoo (r/r T-ALL/LBL) tau pom tseeb los ntawm kev mob sai sai, kev kwv yees tsis zoo thiab tsis muaj kev xaiv kho mob. Tam sim no, tsuas yog Nailabine tau pom zoo los ntawm FDA hauv xyoo 2005 rau kev kho mob ntawm cov neeg mob T-ALL/LBL uas tsis teb rau tsawg kawg yog ob txoj kev kho mob chemotherapy lossis rov qab los tom qab kev kho mob, nrog ORR ntawm 31% thiab CR ntawm 23%. Yog li ntawd, muaj qhov xav tau ceev ceev los tsim lwm yam kev kho mob zoo. Sib nrug los ntawm nws qhov kev qhia tawm hauv cov hlwb T thiab NK ib txwm muaj thiab tsis muaj kev qhia tawm hauv lwm cov hlwb nqaij, CD7 tau qhia tawm ntau heev hauv cov hlwb T-ALL/LBL. Yog li ntawd, CD7 raug suav hais tias yog lub hom phiaj rau kev txhim kho CAR-T kev kho mob rau T-ALL/LBL. Txawm li cas los xij, qhov kev sib tw yog kom tsis txhob muaj kev tua tus kheej los ntawm kev qhia tawm ntawm CD7 hauv T hlwb. Cov kws tshawb nrhiav tau tsim ib qho kev txhaj tshuaj CAR-T cell raws li CD7 nano antibodies, hu ua PA3-17 txhaj tshuaj, los ntawm kev thaiv kev qhia tawm ntawm CD7 molecule ntawm qhov chaw ntawm T cell los ntawm anti-CD7 protein expression blocker (PEBL).
Cov ntaub ntawv soj ntsuam mus sij hawm ntev los ntawm kev sim tshuaj theem I ntawm PA3-17 txhaj tshuaj rau kev kho mob ntawm T-cell mob leukemia/lymphoma (R/R T-ALL/LBL) uas rov qab los/tsis ua haujlwm tau raug nthuav tawm ntawm lub rooj sib tham txog kev kawm thoob ntiaj teb EHA 2025.
Txij li thaum Lub Ob Hlis 19, 2025, tag nrho muaj 13 tus neeg mob tau sau npe (3 tus neeg mob hauv pawg koob tshuaj 1, 2, 3, 4 tus neeg mob hauv pawg RP2D), txhua tus ntawm lawv tau txais ib qho kev txhaj tshuaj PA3-17 thiab ua tiav kev ntsuam xyuas 28-hnub ntawm kev txwv tsis pub muaj tshuaj lom (DLTs). RP2D tau tsim ntawm 2 × 10⁶ CAR-T / kg raws li pharmacokinetics, kev nyab xeeb thiab kev ua tau zoo dhau ntawm qhov koob tshuaj no. Tsis muaj DLTs tshwm sim thiab tsis tau mus txog qhov siab tshaj plaws (MTD). Cytokine release syndrome (CRS) tshwm sim yog 84.6% (G3: 23.1%, tsis muaj G4), thaum immune effector cell-associated neurotoxicity syndrome (ICANS) raug txwv rau G1-2 (15.4%). Cov ntaub ntawv qhia tau tias qhov kev teb zoo tshaj plaws (ORR) yog 84.6% (11/13) thiab 76.9% (10/13) tau txais kev zam txim tag nrho / kev zam txim tag nrho nrog kev rov qab suav tsis tiav (CR / CRi). Qhov tseem ceeb, 69.2% (9/13, 8 tus neeg mob CR) tau tswj hwm kev teb ntawm 3 lub hlis, nrog 50.0% (4/8) tswj hwm CR> 15 lub hlis tom qab infusion yam tsis muaj kev hloov pauv hlwb tom qab (SCT), thiab ob ntawm lawv tseem muaj cov hlwb CAR-T pom tau ntawm 21 lub hlis. Qhov tseem ceeb, tus neeg mob uas tau kho ua ntej hnyav [ua ntej Hematopoietic Stem Cell Transplantation (HSCT), kab mob loj > 7cm] tau txais CR los ntawm hnub 28 thiab thib ob HSCT ntawm 6 lub hlis.
Kev txhaj tshuaj PA3-17 tau ua pov thawj tias nws muaj peev xwm ua tau zoo, ua haujlwm tau zoo thiab ruaj khov rau cov neeg mob r/r T-ALL/LBL uas tau kho mob ntau zaus, nrog rau 50% ntawm cov neeg mob CR tseem muaj sia nyob lossis/thiab tsis muaj kev nce qib ntawm 1 xyoos.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
Xov Tooj: 4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
Lub sijhawm tshaj tawm: Lub Yim Hli-13-2025