Phase I Study -To Assess Safety and Feasibility of IL-8 Receptor Modified Patient-derived Activated CD70 CAR T Cell Therapy in CD70+ Adult GBM and Pediatric High-Grade Gliomas (pHGG)
Summary
This is a phase I study to assess the safety and feasibility of IL-8 receptor modified patient-derived activated CD70 CAR T cell therapy in CD70+ adult glioblastoma
Detailed description
Newly diagnosed CD70 positive adult GBM patients who have undergone surgery for maximal debulking will be enrolled in this 3+3 design dose-escalation clinical trial and undergo peripheral venipuncture for collection of PBMCs for generation of investigational 8R-70CAR T Cell vaccine. Patients will then undergo standard of care chemoradiation. Immunotherapy will begin 2 weeks (-7/+4 days) after completion of radiation. One single dose of 8R-70CAR T cells will be administered IV. The dose will depend on the enrolling cohort. Dose escalation will follow the traditional 3+3 design.
Arms & interventions
- BiologicalEx-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells
Single dose of 8R-70CAR T cells administered IV
Outcome measures
Primary
Safety of 8R-70CAR T-cell therapy in adult patients with de novo CD70+ GBM
Defined as ≤ 1 DLT out of 6 patients is observed at the 1x10\^8 cells/Kg dose. Dose-Limiting toxicity (DLT) will be defined as any adverse event attributable (possible, probable, or definite) to the administration of 8R-70CAR T cells and occurring from the time of infusion through 28 days post-infusion.
Time frame: 28 days post-infusion
Feasibility of 8R-70CAR T-cell therapy in adult patients with de novo CD70+ GBM
Feasibility will be defined as the ability to infuse 8R-70CAR T-cell safely in 66.7 % of enrolled patients (patients who signed consent and were deemed eligible for the study).
Time frame: 10 weeks
Eligibility criteria
Study locations (1)
University of Florida Health
Gainesville, Florida, 32608