IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Newly Diagnosed and Recurrent Pediatric High-grade Glioma (pHGG) and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (ndDIPG)

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age4-30
SponsorUniversity of Florida

About this trial

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)

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells

Treatment groups

24 Participants
are divided into 3 treatment groups

Locations

1
University of Florida Health Children's Hospital32608, GainesvilleFlorida, United States

Sponsors and collaborators

University of Florida

Lead sponsor

Florida Department of Health, Live Like Bella

Collaborator

St. Baldrick's Foundation

Collaborator

American Brain Tumor Association

Collaborator