Phase I study targeting newly diagnosed grade 4 astrocytoma with bispecific antibody armed T cells (EGFR BATs) in combination with radiation and temozolomide.

ABSTRACT:

Purpose

The purpose of this study was to determine the safety, feasibility, and immunologic responses of treating grade 4 astrocytomas with multiple infusions of anti-CD3 x anti-EGFR bispecific antibody (EGFRBi) armed T cells (EGFR BATs) in combination with radiation and chemotherapy.

Methods

This phase I study used a 3 + 3 dose escalation design to test the safety and feasibility of intravenously infused EGFR BATs in combination with radiation and temozolomide (TMZ) in patients with newly diagnosed grade 4 astrocytomas (AG4). After finding the feasible dose, an expansion cohort with unmethylated O⁶-methylguanine-DNA methyltransferase (MGMT) tumors received weekly EGFR BATs without TMZ.

Results

The highest feasible dose was 80 × 10⁹ EGFR BATs wit

SUBMITTER: Fadul CE 

PROVIDER: S-EPMC10834565 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature