Cov Ntaub Ntawv Kho Mob Tshiab Tshaj Plaws ntawm RD13-02 rau Kev Kho Mob R/R T-ALL/LBL Cov Neeg Mob hauv Kev Nthuav Qhia Qhov Ncauj

RD13-02 yog ib yam khoom siv CAR-T cell uas siv tau rau txhua tus neeg uas xav tau CD7 los ntawm cov neeg pub dawb uas noj qab nyob zoo, thiab yog siv rau kev kho mob T-cell uas rov qab mob dua lossis tsis kho tau zoo (T-ALL/LBL). Nws tau hloov kho caj ces kom tsis txhob muaj kev tua kab mob fratricide, kab mob graft-versus-host (GvHD), thiab kev tsis lees txais host-versus-graft (HvG) thaum txhim kho kev ua haujlwm tiv thaiv kab mob qog nqaij hlav. RD13-02 tuaj yeem npaj tau hauv ib pawg rau ntau tus neeg, ua tiav lub peev xwm "tawm ntawm lub txee" rau cov neeg mob uas xav tau kev kho mob CAR-T cell.

Thaum Lub Kaum Ib Hlis 7, 2024, Bioheng Therapeutics tshaj tawm tias nws yuav nthuav tawm cov ntaub ntawv kho mob theem I tshiab tshaj plaws ntawm nws cov khoom lag luam CAR-T cell RD13-02, tsom mus rau CD7 rau kev kho mob ntawm cov neeg mob rov qab los / refractory (R / R) T-ALL / LBL, hauv kev nthuav qhia ntawm 66th American Society of Hematology (ASH) Lub Rooj Sib Tham Txhua Xyoo. Lub rooj sib tham yuav muaj nyob rau lub Kaum Ob Hlis 7-10, 2024, hauv San Diego, Tebchaws Meskas.

Cov Txiaj Ntsig: Txij li Lub Yim Hli 1, 2024, tag nrho muaj 18 tus neeg tsim nyog nrog R/R T-ALL/LBL tau raug sau npe (13 ALL, 5 LBL), nrog rau hnub nyoog nruab nrab ntawm 33.5 xyoo (ntau yam, 11 txog 67). Cov kab kho mob ua ntej nruab nrab yog 2 (ntau yam, 1 txog 5), thiab 4 pts tau ua ntej allo-HSCT ua ntej sau npe. Qhov feem pua ​​​​​​nruab nrab ntawm BM blasts yog 71% (ntau yam: 6% txog 90%) ntawm 18 pts, nrog rau 9 (6 ALL, 3 LBL) qhia txog kev koom tes extramedullary. Tsis muaj qhov xwm txheej tshuaj lom (DLT) lossis neurotoxicity tau pom ntawm txhua qib koob tshuaj, nrog tsuas yog ib rooj plaub ntawm Gr1 GvHD tshwm sim. Cytokine tso tawm syndrome (CRS) tau tswj tau nrog feem ntau yog me me (Gr1, n = 10; Gr2, n = 5; Gr3, n = 3). Kev kis kab mob txhua qib tau tshwm sim hauv 13 (72%) pts (≥Gr3 hauv 2 [11%] pts). Vim muaj Gr3 CRS tshwm sim hauv ib pt txhua los ntawm DL2 thiab DL3 theem, cov kws tshawb nrhiav tau teeb tsa DL1 ua qhov kev nthuav dav nrog kev tsom mus rau kev nyab xeeb thiab kev ua tau zoo. Thaum lub sijhawm nthuav dav koob tshuaj, ib pt tuag los ntawm kev mob qog nqaij hlav lysis syndrome rau Hnub 20 tom qab infusion.

Thaum thawj 28 hnub kev ntsuam xyuas tom qab txhaj tshuaj, 14 ntawm 17 cov qhab nia tau ntsuas tau ua tiav CR/CRi. Thaum lub hlis thib 2 tom qab txhaj tshuaj, ob lub qhab nia ntxiv tau mus txog CR/CRi, nrog rau tus nqi CR/CRi ntawm 94% (16/17). Ntawm cov qhab nia nrog CR/CRi, 100% tau ua tiav qhov xwm txheej tsis zoo ntawm tus kab mob seem tsawg kawg nkaus (MRD) los ntawm kev tshuaj xyuas cov cytometry. Tus nqi nruab nrab Cmax ntawm CAR-T hlwb hauv cov ntshav peripheral yog 1,863,601 daim ntawv theej/μg genomic DNA (ntau yam, 275,044 txog 3,763,587) los ntawm qPCR, nrog rau lub sijhawm ntev tshaj 90 hnub.

Xaus Lus: RD13-02, ib yam khoom CAR-T uas muag tau thoob ntiaj teb, qhia tau tias muaj kev nyab xeeb thiab ua tau zoo dua hauv kev kho R/R CD7 T-ALL/LBL. Qhov tseem ceeb, 100% ntawm CR/CRi pts tau txais MRD-negative, muab cov pts ntau txoj kev xaiv kho mob sai dua.

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.

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Cov ntaub ntawv siv los ua piv txwv

1.https://www.bioheng.com/News_Details/26.html

2.https://ash.confex.com/ash/2024/webprogram/Paper207322.html

3.http://myimm.net/mianyizhiliao/2035.html