satricabtagene autoleucel (Satri-cel, CT041) yog ib yam khoom siv CAR T-cell uas muaj peev xwm tiv thaiv tau cov protein Claudin18.2 uas muaj peev xwm ua thawj zaug hauv ntiaj teb. Satri-cel tsom mus rau cov qog nqaij hlav Claudin18.2 uas muaj Claudin18.2 nrog rau kev tsom mus rau mob qog noj ntshav hauv plab/mob qog noj ntshav hauv plab (GC/GEJ) thiab mob qog noj ntshav hauv plab (PC).
Cov txiaj ntsig kawg ntawm kev sim tshuaj CT041-CG4006 (NCT03874897) ntawm satricabtagene autoleucel tau muab luam tawm hauv Nature Medicine rau lub Rau Hli 3, 2024.
Tag nrho muaj 98 tus neeg mob tau koom nrog kev sim, thiab cov txiaj ntsig tau qhia tias tus nqi tswj kab mob (DCR) siab txog 91.8%, 38 tus neeg mob tau txais kev zam txim, tag nrho tus nqi zam txim yog 38.8%, qhov nruab nrab ntawm kev ciaj sia tsis muaj kev nce qib (PFS) yog 4.4 lub hlis, qhov nruab nrab ntawm kev ciaj sia tag nrho (OS) yog 8.8 lub hlis, thiab lub sijhawm nruab nrab ntawm kev zam txim (mDOR) yog 6.4 lub hlis. Ntawm 90 tus neeg mob uas tau raug mob, 70 tus neeg mob tau txais kev hloov pauv ntawm ntau qib ntawm qog nqaij hlav.
Ntawm 51 tus neeg mob qog noj ntshav hauv plab uas tau kho nrog Satri-cel ib leeg xwb, tus nqi tswj kab mob tau siab txog 96.1% (49), thiab tus nqi teb tag nrho yog 54.9% (28). Ntawm lawv, 27 tus neeg mob tau txais kev teb ib nrab (PR), 1 tus neeg mob tau txais kev teb tiav (CR), thiab lub sijhawm teb nruab nrab (mDOR) yog 6.4 lub hlis.
Xaus lus
Satri-cel qhia tau tias muaj peev xwm kho tau nrog cov qauv kev nyab xeeb uas tswj tau hauv cov neeg mob uas muaj mob qog noj ntshav hauv plab hnyuv CLDN18.2-zoo.
Thaum lub Cuaj Hlis 9, 2023, ob rooj plaub ntawm kev kho mob qog nqaij hlav pancreatic metastatic nrog CARsgen's CT041, ib qho tshiab Claudin (CLDN) 18.2 CAR T-cell Therapy, tau luam tawm hauv Journal of Hematology & Oncology hu ua "CT041 CAR T cell therapy rau Claudin18.2 positive metastatic pancreatic cancer".
Rau rooj plaub 1, ib tug poj niam hnub nyoog 58 xyoo tau kuaj pom tias muaj mob qog nqaij hlav pancreatic nrog rau lub ntsws thiab cov qog ntshav hauv lub qog. Kab thawj zaug nab-paclitaxel ntxiv rau gemcitabine thiab kab thib ob irinotecan-liposome ntxiv rau 5-flurouracil tsis ua haujlwm ua ntej nws raug sau npe rau hauv CT041 kev sim tshuaj, tom qab lees paub CLDN18.2 kev qhia tawm li 2+/70%. Tom qab lymphodepletion uas muaj fludarabine, cyclophosphamide, thiab nab-paclitaxel, CT041 koob tshuaj ntawm 250 × 106cov hlwb tau muab rau tus neeg mob thaum lub Cuaj Hli 2021. Qib 2 cytokine tso tawm syndrome (CRS) tau tshwm sim, uas tom qab ntawd tau tswj hwm los ntawm tocilizumab. Ib feem ntawm cov lus teb (PR) tau ua tiav raws li RECIST v1.1, nrog rau kev txo qis ntawm lub ntsws metastasis.
Rau rooj plaub 2, ib tug poj niam hnub nyoog 75 xyoo tau kuaj pom tias yog mob qog nqaij hlav pT2N0 tom qab nws tau phais mob thaum lub Tsib Hlis 2019. Kev kis mus rau lwm qhov ntawm lub ntsws tau pom tom qab 5 lub hlis thaum lub sijhawm ua raws li kev phais mob tas li. Kev kho mob S-1 monotherapy tau muab ua thawj kab chemotherapy pib txij lub Kaum Ob Hlis 2019. Thaum lub sijhawm phais mob palliative radiation, kev nce qib ntawm qog tau pom hauv lub ntsws. Txij li thaum CLDN18.2 kev qhia tau txiav txim siab tias yog 3 + / 60%, tus neeg mob tau sau npe rau hauv CT041 kev sim tshuaj. Tom qab tau txais lymphodepletion uas muaj fludarabine, cyclophosphamide thiab nab-paclitaxel, tus neeg mob tau txhaj tshuaj CT041 ntawm 250 × 106cov hlwb thaum Lub Xya Hli 2021. Tus neeg mob tau ntsib qib 2 CRS, uas tau tswj hwm ntxiv nrog tocilizumab. PR tau mus txog txij li thawj qhov kev ntsuam xyuas 4 lub lis piam tom qab infusion. Lub hom phiaj lesions ntawm lub ntsws metastasis tom qab ntawd ploj mus thiab ua tiav kev teb tiav. Lub qog tseem nyob hauv kev tswj hwm zoo kom txog thaum kawg kev saib xyuas thaum Lub Xya Hli 2023. Tus lej luam ntawm cov ntshav peripheral CLDN18.2 CAR hauv ob tus neeg mob tau pom tias muaj kev nce ntxiv sai tom qab infusion, nce mus txog hauv 2 lub lis piam. Tib lub sijhawm, cov txiaj ntsig fluorescence-activated cell sorting qhia txog kev nce ntxiv hauv cov ntshav peripheral CD8 T hlwb thiab Treg hlwb, nrog rau kev txo qis hauv CD4 T hlwb thiab B hlwb. Cov kev hloov pauv no hauv cov qauv hlwb tiv thaiv kab mob tau qhia txog kev ua siab ntev dua piv rau kev hloov pauv hauv cov cytokine theem.
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.
Xov Tooj: 4008803716
Email:myimmnet@163.com
Cov ntaub ntawv siv los ua piv txwv
1.https://www.carsgen.com/en/news/carsgen-presents-updated-results-on-satri-cel-in-nature-medicine-and-at-2024-asco/
2.https://www.nature.com/articles/s41591-024-03037-z
3.https://www.carsgen.com/media/fooloi3a/ct041-cg4006-asco-2024_v3-0_20240603.pdf
4.https://jhoonline.biomedcentral.com/articles/10.1186/s13045-023-01491-9
Lub sijhawm tshaj tawm: Kaum Ib Hlis-21-2024