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)
University of Florida
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
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.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria (Adult GBM): * Age ≥ 18 years * Newly-diagnosed de novo GBM based on the absence of previous history of brain tumor (WHO Grade IV glioma) by histopathology or molecular studies. (secondary GBM not eligible) * The tumor must have a supratentorial component * CD70 positive (≥5%, 1+) Tumor expression will be scored on a scale of 0 to 3 staining intensity: 0 = Negative 1. = Low level 2. = Moderate level 3. = High level * The criteria for inclusion will be at least 5% of the cells scoring 1+ staining intensity (\> 5%, 1+). * Surgical resection of tumors with less th…
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
Location
- University of Florida HealthGainesville, Florida