RD13-02 ndi mankhwala a maselo a CAR-T omwe amagwiritsidwa ntchito pochiza matenda a khansa ya m'magazi/lymphoma ya T-cell yomwe yabwereranso kapena yosagwirizana nayo (T-ALL/LBL). Amasinthidwa majini kuti apewe fratricide, matenda a graft-versus-host (GvHD), ndi host-versus-graft rejection (HvG) pamene akuwonjezera mphamvu yolimbana ndi chotupa. RD13-02 ikhoza kukonzedwa m'gulu limodzi kwa anthu angapo, zomwe zimapangitsa kuti odwala omwe akufunika chithandizo cha maselo a CAR-T azitha kuchita bwino kwambiri.
Pa Novembala 7, 2024, Bioheng Therapeutics yalengeza kuti ipereka deta yaposachedwa yachipatala ya Gawo I ya mankhwala ake onse a CAR-T cell RD13-02, omwe cholinga chake ndi kuchiza odwala omwe abwereranso m'thupi/osachira (R/R) T-ALL/LBL, mu ulaliki wa pakamwa pa Msonkhano Wapachaka wa 66 wa American Society of Hematology (ASH). Msonkhanowu udzachitika kuyambira pa Disembala 7-10, 2024, ku San Diego, USA.
Zotsatira: Pofika pa Ogasiti 1, 2024, anthu 18 oyenerera omwe ali ndi R/R T-ALL/LBL adalembetsa (13 ALL, 5 LBL), ndi zaka zapakati pa 33.5 (zaka, 11 mpaka 67). Apakati pa mankhwala omwe adagwiritsidwa ntchito kale anali awiri (zaka, 1 mpaka 5), ndipo 4 anali ndi allo-HSCT asanalembetsedwe. Chiŵerengero chapakati cha BM blasts chinali 71% (zaka: 6% mpaka 90%) pakati pa 18, ndipo 9 (6 ALL, 3 LBL) zikuwonetsa kukhudzidwa kwa extramedullary. Palibe chochitika choletsa poizoni (DLT) kapena poizoni wa mitsempha chomwe chidawonedwa pamlingo wonse wa mlingo, pomwe panali vuto limodzi lokha la Gr1 GvHD. Cytokine release syndrome (CRS) idathetsedwa ndipo ambiri anali ofatsa (Gr1, n=10; Gr2, n=5; Gr3, n=3). Matenda aliwonse a mtundu uliwonse adachitika m'magawo 13 (72%) (≥Gr3 m'magawo awiri [11%)). Chifukwa cha kupezeka kwa Gr3 CRS mu gawo limodzi lililonse kuchokera ku DL2 ndi DL3 levels, ofufuza adayika DL1 ngati mlingo wowonjezera womwe umayang'ana kwambiri chitetezo ndi magwiridwe antchito. Pakukula kwa mlingo, pt imodzi idamwalira ndi tumor lysis syndrome pa Tsiku la 20 pambuyo pa kulowetsedwa.
Pa nthawi yoyamba yowunikira masiku 28 pambuyo polowetsedwa, ma pts 14 mwa 17 omwe adayesedwa adapeza CR/CRi. Pomwe pofika mwezi wachiwiri pambuyo polowetsedwa, ma pts ena awiri adafika pa CR/CRi, ndi chiŵerengero cha CR/CRi cha 94% (16/17). Pakati pa ma pts omwe ali ndi CR/CRi, 100% adapeza mkhalidwe wochepa wa matenda otsalira (MRD) mwa kusanthula kwa flow cytometry. Cmax yapakati ya maselo a CAR-T m'magazi ozungulira inali 1,863,601 copies/μg genomic DNA (range, 275,044 mpaka 3,763,587) ndi qPCR, ndipo nthawi yayitali kwambiri idapitilira masiku 90.
Pomaliza: RD13-02, chinthu chogwiritsidwa ntchito kwambiri cha CAR-T, chawonetsa chitetezo chodalirika komanso chogwira ntchito bwino pochiza R/R CD7 T-ALL/LBL. Chodziwika bwino n'chakuti, 100% ya CR/CRi pts inali ndi MRD-negative, zomwe zinapatsa ma pts njira zambiri zochizira mwachangu.
Pakadali pano, pali mayeso ena ambiri azachipatala a CAR-T ku China, ndipo akufunafuna odwala. Kuti mumve zambiri za mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
Nambala ya Foni: 4008803716
Email：myimmnet@163.com
Zolemba
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
Nthawi yotumizira: Disembala-03-2024