Actively Recruiting
A Phase 1 Trial to Evaluate the Safety of EGFR/IL13Rα2 Pool-CAR T Cells in Patients With Recurrent or Progressive High-Grade Glioma
Led by City of Hope Medical Center · Updated on 2026-05-06
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and best dose of EGFR/IL13Rα2 pool-chimeric antigen receptor (CAR) T cells given directly into the brain to treat patients with recurrent or progressive high-grade gliomas. These gliomas are aggressive brain tumors that have returned or worsened after previous treatments. The study is a phase I trial focused on this new type of CAR T cell therapy, which involves modifying a patient's immune cells to target tumor cells. Participants undergo leukapheresis to collect their immune cells, followed by surgery to place catheters into the brain. The modified CAR T cells are then infused through these catheters once a week for up to four cycles, with possible additional cycles based on tolerance and disease status. Throughout the study, participants receive imaging scans and various sample collections to monitor treatment effects and safety. Follow-up continues for many years to observe long-term outcomes. During the trial, patients will have blood tests, brain scans (MRI and FDG-PET), and sample collections from blood, cerebrospinal fluid, and the tumor area. Researchers will monitor side effects and measure responses such as disease control, time to progression, and survival. Safety is assessed up to 15 years after treatment, with detailed evaluations of immune responses and tumor changes. This comprehensive monitoring helps understand how the therapy works and its potential risks over time.
CONDITIONS
Brief Title
Locoregional Administration of Genetically Engineered Cells (EGFR/IL13Rα2 Pool-CAR T Cells) for the Treatment of Recurrent or Progressive High-Grade Gliomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent or have a legally authorized representative consent
- Agree to allow use of archival tumor tissue or obtain study approval if unavailable
- Age 18 years or older
- Karnofsky Performance Status (KPS) of 70% or higher and ECOG score 2 or less
- Life expectancy of at least 4 weeks
- Prior confirmed diagnosis of glioblastoma (IDH-wildtype) or grade 4 IDH-mutant astrocytoma, or progression from grade 2 or 3 astrocytoma to grade 4
- Evidence of measurable recurrent or progressive disease after standard therapy, at least 12 weeks after radiation
- Tumor expresses IL13Rα2 by immunohistochemistry and has EGFR gene alterations by genetic testing
- No contraindications to leukapheresis, steroids, imaging, or tocilizumab
- White blood cell count greater than 2000/dl or absolute neutrophil count at least 1000/mm3
- Platelet count of at least 75,000/mm3
- Hemoglobin greater than 8 g/dL
- Liver function tests within specified limits
- Serum creatinine less than or equal to 1.6 mg/dL
- Oxygen saturation at least 95% on room air
- Negative tests for HIV, hepatitis C, and active hepatitis B
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control or abstain from heterosexual activity during study and for 3 months after last dose
You will not qualify if you...
- Current use of bevacizumab therapy
- Not recovered from prior therapy toxicities
- Received live vaccine within 30 days before enrollment
- Uncontrolled seizures or progressive encephalopathy
- History of allergic reactions to similar compounds
- Uncontrolled serious illness
- Active autoimmune disease needing systemic immunosuppressive therapy
- Active infection requiring intravenous antibiotics
- Known HIV, hepatitis B, or hepatitis C infection
- Other active cancers
- Pregnant or breastfeeding women
- Any condition that makes participation unsafe or not feasible
- Inability to comply with study procedures due to safety or logistical reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 3 weeks
Participants undergo leukapheresis followed by surgical resection, biopsy, and placement of intracranial tumoral and/or ventricular catheters prior to treatment.
Several visits for procedures including leukapheresis, surgery, and catheter placement
Duration - Up to 4 weeks or longer if additional cycles are given
Participants receive EGFR/IL13Rα2 pool-CAR T cells via intracranial catheters once weekly for up to 4 cycles, with the possibility of additional cycles based on clinical discretion.
Weekly visits for up to 4 weeks with possible additional visits
Duration - Up to 15 years
Participants are monitored for safety, disease progression, and treatment effects with visits scheduled up to 15 years after the last CAR T cell infusion.
Visits at Day 30, Months 3, 6, 9, 12, then yearly
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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