Glioblastoma Multiforme (GBM) ndeimwe yekenza inouraya zvakanyanya, uye varwere vakawanda vanodzoka vachirwara neGBM zvichienderana nekurapwa kwazvino uno kweGBM. GBM inodzoka (rGBM) inoratidza kurarama kwepakati pemwedzi isingasviki misere nesarudzo shoma dzekurapa.
TX103 mushonga wekurapa nemasero eCAR-T unoshandiswa pakurapa B7-H3, wakagadzirwa wega uye wakabvumidzwa nemapatendi ekuChina neepasi rose. Mhedzisiro yekutanga yekurapa kweTX103 yezvirwere zvegliomas zvinodzoka yakapihwa paMusangano weGore negore weAmerican Society of Clinical Oncology (ASCO) muna 2024.()NCT05241392）.
Nzira: Iyi iongororo yakavhurika, ine ruoko rumwe chete, ye "3+3″ dose-wescaling-and-dose-excellation uye multiple dose. Chinangwa chikuru chaive chekuongorora kuchengetedzeka uye dose yakanyanya kushivirira. Zvinangwa zvechipiri zvaisanganisira mhedzisiro yekurarama, mhinduro dzebundu, mhinduro dzemuviri, uye pharmacokinetic parameters. Varwere vane makore 18 kusvika 75 vakanyoreswa uye kudzoka kwakasimbiswa nemifananidzo scan uye B7-H3 expression >= 30% ne immunohistochemistry analysis. TX103 yakapihwa intracavity uye/kana intraventricularly kuvarwere kuburikidza neOmmaya reservoir. TX103 yakapihwa kaviri pavhiki kuvarwere kutenderera kwega kwega padanho redose 1, 2, uye 3 (20, 60, 150 miriyoni masero, zvichiteerana), nematanho mana senzira imwe chete.
Mhedzisiro: Pakati paKurume 2022 naNdira 2024, varwere gumi nevatatu vakapinzwa TX103 kamwe chete mumusoro, pamwe nevarwere vatatu, vana, uye vatanhatu vari mumazinga edosi 1, 2, uye 3, zvichiteerana. Huwandu hwepakati hwemadanho edosi 1, 2, uye 3 hwakafanana. Huwandu hwepakati hwemadanho edosi 4 (Min, Max 1,9). Varwere vese vakaverengerwa muongororo yekuchengetedzeka, zvichiratidza kuti hapana chepfu inoganhurira dosi kana kufa neCAR-T kurapwa. Varwere vese vakasangana nechiitiko chimwe chete chakaipa (AE), uye maAE ane chekuita nekurapa (TRAEs) aisanganisira cytokine release syndrome, kuwedzera kwekumanikidzwa kwemukati memusoro (ICP), musoro, pfari, kudzikira kwekuziva, kurutsa, uye pyrexia. Mazhinji eTRAE aive egiredhi 1-2, nepo matatu egiredhi-3 eTRAE akaonekwa: imwe nyaya yekuwedzera ICP muchikamu chechipiri chedosi, imwe nyaya yepfari, uye imwe nyaya yekudzikira kwekuziva muchikamu chechitatu chedosi. Kubva munaNdira 2024, varwere vatanhatu vemazinga edosi 1 ne2 vakakodzera kuongororwa kwekurarama kwemwedzi gumi nemiviri; Mwero wekurarama kwemwedzi gumi nemiviri (OS) waive 83.3% (95% CI: 58.3% ~ 100%), uye avhareji yeOS yaive 20.3 mwedzi (95% CI: 20.3 ~ isingasvike). Vaviri vevarwere vatatu vedanho rechipiri redose vakawana mhinduro dzisina kukwana uye dzakakwana, zvichiteerana. Mushure mekupiwa CAR-T, kuwedzera kukuru kwema cytokines, kusanganisira IL-6 ne IFN-γ, uye nhamba dzakakwira dzemakopi e CAR gene zvakaonekwa mu cerebrospinal fluid, nepo kukwira kudiki chete kwakaonekwa muropa rekunze.
Mhedziso: Muongororo iyi, kurapa rGBM neTX103 kunoonekwa sekunge kwakachengeteka uye kunobvumirwa. Mhedzisiro iyi yepakati inotsigira ongororo yakawedzerwa uchishandisa TX103 kuti iwedzere mhedzisiro yekurarama kwevarwere vane rGBM.
Parizvino, kune mimwe miedzo yakawanda yeCAR-T muChina, uye vari kutsvaga varwere. Kuti muwane mazano pamusoro pemishonga mitsva netekinoroji, munogona kubata Beijing South Region Oncology Hospital International Department.
Nhamba yefoni: 4008803716
Email：myimmnet@163.com
Nguva yekutumira: Zvita-09-2024