Zevor-cel tau pom zoo rau kev teev npe

Thaum Lub Peb Hlis 1, 2024, Tuam Tshoj Lub Chaw Tswj Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau pom zoo tso tawm CAR-T cell khoom Zevorcabtagene AutoLeucel (Zevor-cel, CT053) rau kev kho mob rau cov neeg laus uas muaj mob myeloma rov qab los lossis tsis kho tau uas tau nce qib tom qab tsawg kawg 3 kab kev kho mob (siv tsawg kawg ib qho proteasome inhibitor thiab immune modulator).

Daim ntawv teev npe no feem ntau yog raws li kev sim tshuaj theem II uas qhib rau pej xeem, ib sab caj npab, ntau lub chaw (LUMMICAR STUDY 1,NCT03975907) hauv Suav teb, uas tau ua tiav 100% kev zam txim.

Muaj 14 tus neeg mob uas muaj hnub nyoog nruab nrab ntawm 54 xyoo (ntau yam: 34-62), tau txais ib qho kev txhaj tshuaj zevor-cel. Txij li thaum Lub Xya Hli 17, 2023, lub sijhawm nruab nrab ntawm kev saib xyuas yog 37.7 lub hlis (ntau yam: 14.8-44.2 lub hlis). Qhov feem pua ​​​​​​ntawm kev teb tag nrho (ORR) yog 100% (14/14) nrog 78.6% (11/14) tus neeg mob tau txais kev teb tiav (CR) lossis kev teb tiav (sCR); qhov tsis zoo ntawm cov kab mob seem tsawg kawg nkaus (MRD) tau ua tiav rau txhua tus neeg mob uas tau txais CR lossis sCR. Lub sijhawm nruab nrab ntawm kev teb (mDOR) yog 24.1 lub hlis rau txhua tus neeg mob thiab 26.0 lub hlis rau cov neeg uas tau txais CR lossis sCR. Qhov muaj sia nyob nruab nrab tsis muaj kev nce qib (mPFS) yog 25.0 lub hlis. Tag nrho ntawm 7 (50%) tus neeg mob tau zam txim ntev dua 24 lub hlis. Qhov nruab nrab ntawm tag nrho cov ciaj sia (OS) tsis tau mus txog, thiab 92.9% (13/14) ntawm cov neeg mob tseem muaj sia nyob rau lub hlis 36.

Kev Nyab Xeeb
Zuag qhia tag nrho, qhov kev nyab xeeb ntawm zevor-cel yog qhov tswj tau. Tsis muaj qhov xwm txheej ≥ Qib 3 cytokine tso tawm syndrome (CRS) . Tsis muaj qhov xwm txheej immune effector cell-associated neurotoxicity syndrome (ICANS) ntawm txhua qib. Peb qhov kev kis kab mob Qib 3 uas cuam tshuam nrog kev kho mob tau pom. Peb tus neeg mob tau ntsib cov xwm txheej tsis zoo loj heev (SAE) suav nrog 2 tus neeg mob uas muaj SAEs cuam tshuam nrog kev kho mob uas yog kev kis kab mob ntsws thiab mob qog nqaij hlav lysis syndrome. Muaj tag nrho 2 tus neeg tuag hauv kev tshawb fawb; tsis muaj ib qho twg cuam tshuam nrog zevor-cel.

Xaus lus
zevor-cel tau ua pov thawj tias muaj kev nyab xeeb zoo nrog cov lus teb tob thiab ruaj khov uas sib xws nrog cov txiaj ntsig thawj zaug.

Tam sim no, muaj ntau lwm yam kev sim tshuaj CAR-T hauv Suav teb, thiab lawv tab tom nrhiav cov neeg mob. Yog xav tau 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: 4008803716.

Cov ntaub ntawv siv los ua piv txwv

1.https://www.carsgen.com/cn/

2.http://sh.news.cn/20240314/2913c85a84be4fbf9345efbd48006971/c.html

3.http://myimm.net/mianyizhiliao/1413.html

4.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20240301143753188.html