CAR T Cell Therapy for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase I trial studies the side effects and best dose of EGFR/IL13Rα2 pool-chimeric antigen receptor (CAR) T cells when given through a thin, flexible tube into the brain (locoregional administration) in treating patients with high-grade gliomas that have come back after a period of improvement (recurrent) or that are growing, spreading, or getting worse (progressive). EGFR/IL13Rα2 pool-CAR T cells are a type of CAR T cell therapy. CAR T cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's tumor cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers.
Who Is on the Research Team?
Behnam Badie
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo leukapheresis, surgical resection, biopsy, and catheter placement followed by EGFR/IL13Rα2 pool-CAR T cell infusion every 7 days for up to 4 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment with follow-up visits at day 30, months 3, 6, 9, and 12, and then yearly for up to 15 years
Extension
Participants may receive additional cycles of EGFR/IL13Rα2 pool-CAR T cells per principal investigator and patient discretion
What Are the Treatments Tested in This Trial?
Interventions
- Autologous Anti-EGFR/Anti-IL13Ralpha2 CAR T-cells
- Intracranial Catheter Placement
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients undergo leukapheresis followed by surgical resection, biopsy, and ICT and/or ICV catheter placement 1-3 weeks prior to cycle 1, day 0. Patients then receive EGFR/IL13Rα2 pool-CAR T cells via ICT and/or ICV catheter over 5 minutes on day 1 of each cycle. Cycles repeat every 7 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive additional cycles of EGFR/IL13Rα2 pool-CAR T cells per PI and patient discretion and/or undergo additional leukapheresis as needed on study. Patients also undergo ECHO during screening, as well as FDG-PET, MRI, and blood, TCF, and CSF sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
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