Peds IMPACT: Phase I Study -To Assess 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)
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 newly diagnosed and recurrent CD70+ Pediatric High-Grade Gliomas (pHGG) and Diffuse Intrinsic Pontine Glioma (ndDIPG)
Description
Identified newly-diagnosed or recurrent/progressive pediatric CD70+ HGG and newly diagnosed CD70+ DIPG patients (after first 2 HGG patients are treated) will be enrolled in this clinical trial study prior to initiation of standard-of-care chemo-radiation. Prior to initiation of chemoradiation, PBMCs will be collected through peripheral venipuncture. After tumor CD70 status is confirmed, the 8R-70CAR T cell production will start. 4 weeks (+/- 1) post completion of radiation, pediatric patients, based on institutional policy, will initiate adjuvant chemo with dose-intensified TMZ 75-100 mg/m2/d…
Eligibility
- Age range
- 4–30 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: At enrollment: * Patients with a histologically confirmed diagnosis of: * 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 M+ disease without gliomatosis cerebri (see definition under exclusion criteria) ARE eligible. * Patients with primary spinal cord tumors ARE eligible. * CD70 positive (≥5%, 1+) The tumors from the surgical resection by immunohistochemistry wi…
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 Health Children's HospitalGainesville, Florida