I-RD13-02 iwumkhiqizo wamaseli e-CAR-T ajwayelekile ahlose i-CD7 etholakala kubanikeli abanempilo, futhi ihloselwe ukwelapha i-T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL) ephinde yabuya noma engaphikisi. Ishintshwe ngokwezakhi zofuzo ukuze kugwenywe i-fratricide, isifo se-graft-versus-host (GvHD), kanye nokwenqatshwa kwe-host-versus-graft (HvG) ngenkathi kuthuthukiswa umsebenzi wokulwa nomdlavuza. I-RD13-02 ingalungiswa ngeqoqo elilodwa labantu abaningi, ifinyelele ikhono "elingekho eshelufini" leziguli ezidinga ukwelashwa kwamaseli e-CAR-T.
Ngomhlaka-7 Novemba 2024, i-Bioheng Therapeutics yamemezela ukuthi izokwethula idatha yakamuva yezokwelapha yeSigaba I somkhiqizo wayo weseli le-CAR-T jikelele i-RD13-02, ihlose i-CD7 yokwelapha iziguli eziphinde zagula/ezingalapheki (R/R) T-ALL/LBL, esethulweni somlomo eMhlanganweni Waminyaka Yonke we-66th American Society of Hematology (ASH). Ingqungquthela izokwenzeka kusukela ngomhlaka-7-10 Disemba 2024, eSan Diego, e-USA.
Imiphumela: Kusukela ngomhlaka-1 Agasti 2024, kwabhaliswa ama-pts ayi-18 afanelekile ane-R/R T-ALL/LBL (13 ALL, 5 LBL), eneminyaka ephakathi engu-33.5 (ibanga, 11 kuya ku-67). Imigqa yokwelapha yangaphambili ephakathi yayiyi-2 (ibanga, 1 kuya ku-5), kanti ama-pts ayi-4 ayene-allo-HSCT ngaphambi kokubhaliswa. Ingxenye ephakathi yokuqhuma kwe-BM yayingu-71% (ibanga: 6% kuya ku-90%) phakathi kwama-pts ayi-18, kanti ayi-9 (6 ALL, 3 LBL) abonisa ukubandakanyeka kwangaphandle kwe-medullary. Akukho sigameko sokunciphisa ubuthi (DLT) noma ubuthi be-neurotoxicity esabonwa kuwo wonke amazinga omthamo, kanye necala elilodwa kuphela le-Gr1 GvHD elenzekile. I-Cytokine release syndrome (CRS) yaphathwa kahle kanti iningi layo lalilincane (Gr1, n=10; Gr2, n=5; Gr3, n=3). Ukutheleleka kwanoma yiliphi izinga kwenzeke kuma-pts ayi-13 (72%) (≥Gr3 kuma-pts ama-2 [11%]). Ngenxa yokuvela kwe-Gr3 CRS ku-pts eyodwa ngayinye kusuka emazingeni e-DL2 kanye ne-DL3, abacwaningi babeka i-DL1 njengomthamo wokukhulisa ngokugxila kakhulu ekuphepheni nasekusebenzeni kahle. Ngesikhathi sokwandiswa komthamo, i-pt eyodwa yashona ngenxa ye-tumor lysis syndrome ngosuku lwama-20 ngemuva kokufakwa.
Ekuhlolweni kokuqala kwezinsuku ezingama-28 ngemuva kokufakwa, amaphuzu ayi-14 kwangu-17 ahlolwayo athole i-CR/CRi. Ngenkathi ngenyanga yesi-2 ngemuva kokufakwa, amanye amaphuzu amabili afinyelele ku-CR/CRi, ngesilinganiso se-CR/CRi esingu-94% (16/17). Phakathi kwama-pts ane-CR/CRi, u-100% ufinyelele isimo esibi sesifo esisele (MRD) ngokuhlaziywa kwe-flow cytometry. I-Cmax ephakathi kwamaseli e-CAR-T egazini elingaphandle yayingu-1,863,601 amakhophi/μg ye-genomic DNA (ububanzi, 275,044 kuya ku-3,763,587) nge-qPCR, isikhathi eside kakhulu sidlula izinsuku ezingama-90.
Isiphetho: I-RD13-02, umkhiqizo we-CAR-T ojwayelekile "ongatholakali kalula", ubonise iphrofayili yokuphepha elawulekayo kanye nokusebenza kahle okuthuthukisiwe ekwelapheni i-R/R CD7 T-ALL/LBL. Okuphawulekayo ukuthi ama-CR/CRipts ayi-100% athole isimo se-MRD-negative, enikeza ama-pts izinketho zokwelapha ezisheshayo.
Njengamanje, kunezinye izivivinyo eziningi ze-CAR-T eShayina, futhi zifuna iziguli. Ukuze uthole ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
Email：myimmnet@163.com
Izinkomba
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
Isikhathi sokuthunyelwe: Disemba-03-2024