Idatha yeklinikhi yamva nje ye-RD13-02 yokunyanga izigulane ze-R/R T-ALL/LBL kwi-Oral Presentation

I-RD13-02 yimveliso yeseli ye-CAR-T ejolise kwi-CD7 evela kubanikeli abaphilileyo, kwaye yenzelwe ukunyanga i-T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL) ephinde yabuyela kwi-relaxation okanye enganyangekiyo. Iguqulwe ngokwemfuza ukuze kuthintelwe i-fratricide, isifo se-graft-versus-host (GvHD), kunye nokwaliwa kwe-host-versus-graft (HvG) ngelixa iphucula umsebenzi wokulwa ne-tumor. I-RD13-02 ingalungiselelwa kwiqela elinye labantu abaninzi, ifezekisa amandla "angaphandle kweshelufu" kwizigulana ezifuna unyango lweseli ye-CAR-T.

Ngomhla wesi-7 kweyeNkanga ngo-2024, iBioheng Therapeutics ibhengeze ukuba iza kuveza idatha yamva nje yeklinikhi yeSigaba soku-1 yemveliso yayo yeseli yeCAR-T jikelele iRD13-02, ijolise kwi-CD7 kunyango lwezigulane eziphinde zagula/ezingenakuchatshazelwa (R/R) T-ALL/LBL, kwintetho yomlomo kwiNtlanganiso yoNyaka yama-66 ye-American Society of Hematology (ASH). Le ngqungquthela iza kubanjwa ukususela nge-7 ukuya kwi-10 kaDisemba ngo-2024, eSan Diego, e-USA.

Iziphumo: Ukusukela nge-1 ka-Agasti 2024, inani elipheleleyo lee-pts ezili-18 ezifanelekileyo ezine-R/R T-ALL/LBL zibhalisiwe (13 ALL, 5 LBL), kunye nobudala obuphakathi kweminyaka engama-33.5 (uluhlu, 11 ukuya kuma-67). Imigca yonyango yangaphambili ephakathi yayiyi-2 (uluhlu, 1 ukuya ku-5), kwaye ii-pts ezi-4 zazine-allo-HSCT ngaphambili ngaphambi kokubhaliswa. Umlinganiselo ophakathi wee-BM blasts yayiyi-71% (uluhlu: 6% ukuya kuma-90%) phakathi kwe-pts ezili-18, kunye ne-9 (6 ALL, 3 LBL) ebonisa ukubandakanyeka ngaphandle kwe-medullary. Akukho siganeko sokuthintela idosi (DLT) okanye ubuthi be-neurotoxicity esibonwe kuzo zonke iinqanaba zedosi, kunye nemeko enye kuphela ye-Gr1 GvHD eyenzekayo. I-Cytokine release syndrome (CRS) yayilawuleka kwaye uninzi lwayo lwaluncinci (Gr1, n=10; Gr2, n=5; Gr3, n=3). Usulelo oluvela kwizinga ngalinye lwenzeke kwi-13 (72%) pts (≥Gr3 kwi-2 [11%] pts). Ngenxa yokuvela kwe-Gr3 CRS kwi-pt enye nganye ukusuka kumanqanaba e-DL2 kunye ne-DL3, abaphandi bamisela i-DL1 njengedosi yokwandisa begxile kakhulu kukhuseleko kunye nokusebenza kakuhle. Ngexesha lokwandiswa kwedosi, i-pt enye yafa ngenxa ye-tumor lysis syndrome kwiSuku lama-20 emva kokufakwa.

Kuvavanyo lokuqala lweentsuku ezingama-28 emva kokufakwa, ii-pts ezili-14 kwezili-17 ezivavanyiweyo zifumene i-CR/CRi. Ngelixa kwinyanga yesi-2 emva kokufakwa, ezinye ii-pts ezimbini zifikelele kwi-CR/CRi, kunye nezinga le-CR/CRi elingama-94% (16/17). Phakathi kwee-pts ezine-CR/CRi, i-100% ifumene imeko ye-minimal residue disease (MRD) negative by flow cytometry analysis. I-median Cmax yeeseli ze-CAR-T kwigazi elingaphandle yayiyi-1,863,601 copies/μg genomic DNA (uluhlu, 275,044 ukuya kwi-3,763,587) yi-qPCR, ixesha elide lidlula iintsuku ezingama-90.

Isiphelo: I-RD13-02, imveliso ye-CAR-T eqhelekileyo "engafakwanga eshelufini", ibonise iprofayili yokhuseleko elawulekayo kunye nokusebenza ngcono ekunyangeni i-R/R CD7 T-ALL/LBL. Okuphawulekayo kukuba, i-100% yee-CR/CRipts zifumene imeko ye-MRD-negative, nto leyo enika ii-pts ukhetho olukhawulezileyo lonyango.

Okwangoku, kukho ezinye iimvavanyo ezininzi zeklinikhi ze-CAR-T eTshayina, kwaye zikhangela izigulane. Ukuze ufumane iingcebiso ngamayeza amatsha kunye netekhnoloji, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.

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Email：myimmnet@163.com

Iireferensi

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