Thaum Lub Yim Hli 2025, Lub Chaw Saib Xyuas Kev Tshuaj Xyuas Tshuaj (CDE) ntawm Lub Chaw Tswj Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau tso cai rau Ina-cel Breakthrough Therapy Designation, ib qho kev kho mob tshiab CD19-directed CAR-T cell uas Juventas tsim tawm, rau kev kho mob rau cov menyuam yaus uas muaj mob rov qab los yog tsis kho tau B-cell acute lymphoblastic leukemia (r/r B-ALL).
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
Inaticabtagene autoleucel (Inati-cel) yog ib yam khoom tshwj xeeb ntawm CD19-specific chimeric antigen receptor (CAR) T-cell, uas muaj CD19 scFv uas tau los ntawm clone HI19α thiab 4-1BB/CD3-ζ costimulatory domain, uas tau pom zoo hauv Suav teb rau cov neeg mob laus uas muaj mob B-acute lymphoblastic leukemia (r/r B-ALL) uas rov qab mob dua lossis tsis kho tau thaum lub Kaum Ib Hlis 2023.
LubXyoo 2025 ASCO Lub Rooj Sib Tham Txhua Xyoo daim ntawv qhia Kev tshawb nrhiav ntau lub chaw, tsis yog kev cuam tshuam hauv lub ntiaj teb tiag tiag (NCT06450067) los soj ntsuam Inati-cel rau cov neeg mob laus B-ALL. Nruab nrab ntawm lub Kaum Ib Hlis 20, 2023, thiab lub Kaum Ib Hlis 13, 2024, 62 tus neeg mob tau txais Inati-cel thiab tau soj ntsuam. Lub hnub nyoog nruab nrab yog 37.5 (ntau yam, 14-76) xyoo, nrog rau 13 tus neeg mob hnub nyoog ≥60 xyoo. Thaum kuaj xyuas, 16 tus neeg mob rov qab mob tom qab hematopoietic stem cell transplantation (HSCT), 4 tus neeg mob yog thawj zaug refractory, thiab ntau dua 70% ntawm cov neeg mob nqa cov teeb meem caj ces muaj kev pheej hmoo siab. Lub koob tshuaj infusion nruab nrab yog 0.60 (ntau yam: 0.46-0.9) × 108CAR-T cov hlwb uas muaj sia nyob.
Cov Txiaj Ntsig: Cov ntaub ntawv txij li lub Kaum Ob Hlis 30, 2024, nrog rau qhov nruab nrab ntawm 3.8 lub hlis (ntau yam: 0.5–12.4 lub hlis), 89.5% tau txais MRD-negative ORR tom qab Inati-cel hauv cov neeg mob r/r, suav nrog 31 nrog CR thiab 3 nrog CRi (rooj 1). Cuaj tus neeg mob uas muaj MRD-zoo thaum kuaj mob, tus nqi MRD-negativity tau txog 100% tom qab Inati-cel. Tom qab Inati-cel, 26 tus neeg mob tau txais cov txiaj ntsig MRD pom los ntawm q-PCR, thiab 92.3% tau txais cov txiaj ntsig tsis zoo. Tom qab ua tiav CR/CRi, 4 tus neeg mob tom qab ntawd tau phais allo-HSCT hauv kev zam txim. Tus nqi nruab nrab DOR, OS thiab RFS tsis tau ncav cuag nrog thiab tsis muaj kev tswj hwm cov neeg mob ntawm allo-HSCT tom qab. Ntawm cov neeg mob uas tau soj ntsuam, 1-xyoo RFS thiab DOR tus nqi yog 76.2% thiab 74.1%, raws li. Xya tus neeg mob tau rov qab mob dua, suav nrog 3 CD19+ rov qab mob dua, 2 CD19- rov qab mob dua, thiab 2 uas tsis paub meej tias muaj CD19 li cas. Nws tsim nyog sau cia tias hauv 6 tus neeg mob extramedullary, 4 tus neeg mob tau zoo, tab sis 2 tus neeg mob rov qab mob dua hauv 3 lub hlis tom qab Inati-cel. Tag nrho cov neeg mob uas tau txais Inati-cel infusion tseem muaj sia nyob, tsuas yog ib tus neeg tuag los ntawm kev nce qib ntawm tus kab mob. Cov xwm txheej tsis zoo (AEs) uas feem ntau xav paub tshwj xeeb yog cytokine release syndrome (CRS) thiab immune effector cell-associated neurotoxicity syndrome (ICANS). Tsib caug ib feem pua ntawm cov neeg mob tau tsim CRS, tab sis qib 3 lossis siab dua CRS thiab ICANS tsuas yog tshwm sim hauv 3.2% thiab 1.6% ntawm cov neeg mob, raws li; tag nrho cov neeg mob rov zoo yam tsis muaj sequelae, tsis muaj kev tuag ntsig txog AE.
Kev siv Inati-cel hauv lub ntiaj teb tiag tiag qhia tau tias muaj MRD-negative ORR siab hauv cov neeg laus B-ALL. Cov ntaub ntawv kev nyab xeeb tswj tau, nrog rau qhov tshwm sim tsawg ntawm qib ≥3 CRS thiab ICANS hauv lub ntiaj teb tiag tiag. Cov ntaub ntawv ua raws li ntev dua yuav raug nthuav tawm.
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-26-2025