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 newly diagnosed and recurrent CD70+ Pediatric High-Grade Gliomas (pHGG) and Diffuse Intrinsic Pontine Glioma (ndDIPG)
Newly diagnosed high-grade glioma (WHO Grade III or IV)
Newly diagnosed DIPG (after first 2 HGG patients are treated)
Recurrent or progressive high-grade glioma
Age 4-18 years old for ndHGG. Age 4-30 for rHGG. Age 4-30 for nd DIPG.
Patients with primary spinal cord tumors ARE eligible.
CD70 positive (≥5%, 1+) The tumors from the surgical resection by immunohistochemistry will be confirmed by validated assay performed at UF Health Pathology, CLIA certified Lab.
= Low level
= Moderate level
Parallel
Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells
Biological/VaccineSingle dose of 8R-70CAR T cells administered IV
Incidence of investigational treatment related severe toxicity (Dose-limiting toxicity event)
Safety is defined as the adverse events (AEs), serious adverse events (SAEs) and dose-limiting toxicities (DLT) observed throughout the trial.
Prevalence of enrolled subjects who receive a qualified immunotherapy investigational product.
Feasibility will be measured by the number of patients who receive 8R-70CAR T-cell that met the FDA IND defined quality assurance and quality control release criteria. A minimum of 66.7 % of enrolled subjects must achieve this criterion for the feasibility endpoint.
Maximum tolerated dose (MTD) dose-finding endpoint based on Dose-Limiting-Toxicity (DLT) incidence
Determination of the maximum tolerated dose (MTD) of 8R-70CAR T cells based on the incidence of investigational treatment-related severe toxicity (dose-limiting toxicity events)
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University of Florida
Lead sponsor
Florida Department of Health, Live Like Bella
Collaborator
St. Baldrick's Foundation
Collaborator
American Brain Tumor Association
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
