{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["7(1)"],"submitter":["Whittle JR"],"pubmed_abstract":["<h4>Background</h4>This first-in-human study evaluated EGFRvIII × CD3 TCB, a novel T cell bispecific antibody, in patients with newly diagnosed EGFRvIII-positive glioblastoma.<h4>Methods</h4>Patients with newly diagnosed glioblastoma received escalating doses of EGFRvIII × CD3 TCB following chemoradiation. The primary objectives were to evaluate safety/tolerability and define the maximum tolerated dose (MTD); secondary objectives included pharmacokinetics (PK), immunogenicity, pharmacodynamics, and clinical activity.<h4>Results</h4>Thirty-six patients were enrolled, 32 with unmethylated and 4 with methylated MGMT promoter. EGFRvIII × CD3 TCB doses ranged from 0.004 to 10 mg Q3W, administered either on a flat or step-up dose schedule. One DLT occurred (grade 3 seizure). The MTD was not reac"],"journal":["Neuro-oncology advances"],"pagination":["vdaf160"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12365897"],"repository":["biostudies-literature"],"pubmed_title":["First-in-human study of an EGFRvIII x CD3 T cell bispecific antibody in the treatment of newly diagnosed glioblastoma."],"pmcid":["PMC12365897"],"pubmed_authors":["Heichinger C","Romagnoli B","Prince F","Mellinghoff IK","Dey S","Flinn N","Roller A","Wick A","Mason W","Henkel N","Rosenthal M","Waldhauer I","Wolowski V","Gou JP","Cloughesy T","Schneider M","Smith L","Schiff C","Reardon DA","Chong RA","Whittle JR","Vieito M","Rodriguez-Ruiz ME","Rohrberg K","Castanon E","Van Linde M","Heil F","Derks M"],"additional_accession":[]},"is_claimable":false,"name":"First-in-human study of an EGFRvIII x CD3 T cell bispecific antibody in the treatment of newly diagnosed glioblastoma.","description":"<h4>Background</h4>This first-in-human study evaluated EGFRvIII × CD3 TCB, a novel T cell bispecific antibody, in patients with newly diagnosed EGFRvIII-positive glioblastoma.<h4>Methods</h4>Patients with newly diagnosed glioblastoma received escalating doses of EGFRvIII × CD3 TCB following chemoradiation. The primary objectives were to evaluate safety/tolerability and define the maximum tolerated dose (MTD); secondary objectives included pharmacokinetics (PK), immunogenicity, pharmacodynamics, and clinical activity.<h4>Results</h4>Thirty-six patients were enrolled, 32 with unmethylated and 4 with methylated MGMT promoter. EGFRvIII × CD3 TCB doses ranged from 0.004 to 10 mg Q3W, administered either on a flat or step-up dose schedule. One DLT occurred (grade 3 seizure). The MTD was not reac","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Jan-Dec","modification":"2026-05-29T17:07:47.803Z","creation":"2026-04-08T05:27:23.902Z"},"accession":"S-EPMC12365897","cross_references":{"pubmed":["40842640"],"doi":["10.1093/noajnl/vdaf160"]}}