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Overcoming the highly immunosuppressive glioblastoma (GBM) microenvironment is critical to successful immunotherapy. In a phase I trial we examined the safety and feasibility of a novel adoptive cell immunotherapy platform, activated T cells (ATC) armed with anti-CD3 X anti-EGFR bispecific antibody (EGFR BATs), for patients with newly-diagnosed GBM. We postulate that these EGFR BATs will enhance the response to radiation/temozolomide and potentially increase trafficking to the GBM microenvironment with tumoricidal effect. Autologous T cells obtained by apheresis before radiation/temozolomide were expanded and activated. We used a 3+ 3 design dose-escalation trial to determine the maximum tolerated and feasible dose of three doses of EGFR BATs (80, 120 and 160 billion cells divided in eight infusions) in combination with adjuvant temozolomide after completion of radiation/temozolomide. Seven …