EGFRvIII CAR T Cells for Newly-Diagnosed WHO Grade IV Malignant Glioma

Summary

Please note that enrollment on this study terminated early due to the end of grant funding. Newly diagnosed WHO grade IV malignant glioma subjects who are eligible were enrolled following surgery to remove their brain tumor. They then underwent a leukapheresis to harvest cells for the generation of the study drug, Epidermal Growth Factor variant III Chimeric Antigen Receptor (EGFRvIII CAR) T cells prior to beginning standard of care (SOC) radiation therapy (RT) with temozolomide (TMZ). Once SOC RT with TMZ was completed, subjects returned for the post-RT brain imaging assessment, and, if stable, started post-RT TMZ cycles. Patients received up to 3 cycles of dose-intensified TMZ prior to receiving the EGFRvIII CAR T cells, which was infused in dose escalation cohorts. Following a one-month delay between cycles, the subject resumed post-RT cycles of TMZ and were monitored with blood work and brain imaging as per SOC. An expanded cohort of 12 subjects was originally planned for once the maximally tolerated dose (MTD) was reached in the dose escalation cohorts, in order to obtain a more precise estimate of the probability of unacceptable toxicity and to track the EGFRvIII CAR T cells using 111 Indium (111In) labeling. Computed Tomography (CT) was planned on days 1, 2, and 3 post-infusion to determine intracerebral (IC) localization.

Timeline

Start

2017-02-01

Primary completion

2018-09-25

Completion

2019-09-12

Publications

• Suryadevara CM, Desai R, Abel ML, Riccione KA, Batich KA, Shen SH, Chongsathidkiet P, Gedeon PC, Elsamadicy AA, Snyder DJ, Herndon JE 2nd, Healy P, Archer GE, Choi BD, Fecci PE, Sampson JH, Sanchez-Perez L. Temozolomide lymphodepletion enhances CAR abundance and correlates with antitumor efficacy against established glioblastoma. Oncoimmunology. 2018 Feb 21;7(6):e1434464. doi: 10.1080/2162402X.2018.1434464. eCollection 2018.

Drugs

Indications