CAR T Cell Therapy for Brain Cancer
(IMPACT Trial)
Trial Summary
What is the purpose of 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 CD70+ pediatric high-grade glioma
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on systemic steroids or immunosuppressive agents, you may need to discuss this with the study team, as these could affect eligibility.
What data supports the effectiveness of the treatment Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells for brain cancer?
Is CAR T cell therapy generally safe for humans?
Research Team
Ashley Ghiaseddin, MD
Principal Investigator
University of Florida
Eligibility Criteria
This trial is for children with high-grade gliomas, a type of brain cancer that expresses CD70. Participants must have enough T cells to modify and be able to handle the cell collection process. Specific criteria will determine eligibility.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-treatment
PBMCs are collected through peripheral venipuncture and tumor CD70 status is confirmed
Radiation
Standard-of-care chemoradiation is administered
Adjuvant Chemotherapy
Adjuvant chemo with dose-intensified TMZ 75-100 mg/m2/day for up to 3 cycles
CAR T Cell Treatment
8R-70CAR T cells are administered as a single intravenous infusion
Follow-up
Participants are monitored for safety and effectiveness after CAR T cell infusion
Treatment Details
Interventions
- Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
Florida Department of Health
Collaborator