NCT03344250

Phase I EGFR BATs in Newly Diagnosed Glioblastoma

A Phase I Study Targeting Newly Diagnosed Glioblastoma With Anti-CD3 × Anti-EGFR Bispecific Antibody Armed T Cells (EGFR BATs) in Combination With Radiation and Temozolomide

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I trial using EGFR Bi-armed Activated T-cells (BATs) in combination with standard of care temozolomide (TMZ) and radiation (RT) in patients with glioblastoma (GBM). The purpose of the study is to determine a safe dose of EGFR BATs when given with standard of care therapy.

Detailed description

In addition to finding the safe dose of EGFR BATs, immune evaluations will be performed as delineated in the schedule of events to measure immune responses during all stages of treatment for GBM.

Conditions

• Glioblastoma
• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	EGFR BATs with TMZ following SOC RT/TMZ	Standard of care: 6 weeks of RT and TMZ and 6 cycles of TMZ (150-200 mg/m2) on days 1-5 of each 28 day cycle Experimental: EGFR BATs 2 and 3 weeks after completing RT, and then on day 21 of each cycle of TMZ.
DRUG	Weekly EGFR BATs following SOC RT/TMZ	Standard of care: 6 weeks of RT and TMZ Experimental: 8 weekly doses of EGFR BATs following SOC RT and TMZ

Timeline

• Start date: 2018-03-01
• Primary completion: 2021-12-08
• Completion: 2023-05-08
• First posted: 2017-11-17
• Last updated: 2025-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study