Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: EGFRvIII Chimeric Antigen Receptor (CAR) Gene-modified T Cells for Patients With Newly-Diagnosed GBM During Lymphopenia
Brief Summary: Newly diagnosed glioblastoma subjects who are eligible will be enrolled following surgery to remove the brain tumor. They will then undergo 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 is completed, subjects will return for the post-RT brain imaging assessment, and if stable will start post-RT TMZ cycles. During the 3rd cycle of post-RT TMZ, the EGFRvIII CAR T cells will be infused in dose escalation cohorts. Following a one month delay between cycles, the subject will resume post-RT cycles of TMZ and be monitored with blood work and brain imaging as per SOC. Once the maximally tolerated dose (MTD) is reached in the dose escalation cohorts, an expanded cohort of 12 subjects will be enrolled 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) will be done on days 1, 5, and 10 post-infusion to determine intracerebral (IC) localization.