Actively Recruiting
Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T Cells
Led by Hideho Okada, MD, PhD · Updated on 2026-03-16
20
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
Sponsors
H
Hideho Okada, MD, PhD
Lead Sponsor
C
California Institute for Regenerative Medicine (CIRM)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I trial tests the safety, side effects, and best dose of E-SYNC chimeric antigen receptor (CAR) T cells after lymphodepleting chemotherapy in treating patients with EGFRvIII positive (+) glioblastoma. Chimeric antigen receptor (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 the CAR T cells will attack cancer 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 cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Lymphodepleting chemotherapy with cyclophosphamide and fludarabine before treatment with CAR T cells may make the CAR T cells more effective.
CONDITIONS
Official Title
Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Karnofsky performance status (KPS) score of 70 or higher
- Adequate organ function including neutrophil count ≥1000/mm³, platelet count ≥100,000/mm³ without recent transfusions, lymphocyte count ≥300/µL or CD3 count ≥150/µL
- Creatinine clearance or glomerular filtration rate ≥50 mL/min/1.73m²
- Total bilirubin ≤1.5 times upper limit of normal (ULN) except for Gilbert's syndrome
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times ULN
- Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram or MUGA scan
- Adequate lung function with no resting dyspnea and oxygen saturation >92% on room air
- Confirmed EGFRvIII positive glioblastoma by certified lab testing
- MGMT promoter unmethylated or methylation index less than 3
- Completion of standard external beam radiotherapy as initial therapy
- Ability to complete E-SYNC T cell infusion within 12 weeks after radiotherapy
- Off systemic steroids for at least 3 days before leukapheresis
- Willingness to provide informed consent for apheresis, tissue screening if needed, and study treatment
You will not qualify if you...
- Treatment with investigational agents or chemotherapy targeting glioblastoma within 4 weeks before study registration, with specific exceptions for temozolomide and nitrosourea
- Female participants who are pregnant or breastfeeding
- Known addiction to alcohol or illicit drugs
- Prior treatment with any EGFR-targeting therapy
- Presence of leptomeningeal dissemination
- Known immune system disorders such as HIV or autoimmune diseases requiring systemic cytotoxic or immunosuppressive therapy
- Positive hepatitis B surface antigen or active hepatitis B or C infection confirmed by PCR
- Prior solid organ or bone marrow transplant
- Uncontrolled illnesses including active infection, heart failure, unstable angina, arrhythmia, active second cancers, or psychiatric/social conditions limiting study compliance
- Inability to return for follow-up visits or complete toxicity assessments
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
N
Neuro-Oncology New Patient Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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