Actively Recruiting
Phase 1 Study of Autologous Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13R alpha2 CAR (E-SYNC) T Cells in Adult Participants With EGFRvIII+ Glioblastoma
Led by Hideho Okada, MD, PhD · Updated on 2026-03-16
20
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the safety, side effects, and best dose of a new treatment called E-SYNC chimeric antigen receptor (CAR) T cells for adults with EGFRvIII positive glioblastoma, a type of brain cancer. This phase I trial aims to understand how these specially modified immune cells work after patients receive lymphodepleting chemotherapy. The study also looks at how feasible it is to produce and give these cells, their effects on tumor tissue and blood, and explores immune responses and survival following treatment. Participants are divided into two groups: Cohort 1 includes newly diagnosed patients who have completed radiation therapy, and Cohort 2 includes patients with recurrent glioblastoma who need surgery. Both groups undergo a process called leukapheresis to collect immune cells, followed by chemotherapy with cyclophosphamide and fludarabine given intravenously on days -5, -4, and -3. On day 0, participants receive an infusion of E-SYNC T cells at different dose levels depending on the cohort. Cohort 2 participants also undergo surgical tumor removal between days 14 and 28 after treatment. During the study, participants are closely monitored with scheduled follow-ups ranging from days 1 to 28 after infusion, then at increasing intervals up to 15 years. Researchers assess safety by tracking adverse events, monitor the presence and activation of the CAR T cells in blood and tumor tissue, and evaluate anti-tumor responses. The long-term follow-up includes regular visits and testing to understand the treatment's effects over time and support participant health.
CONDITIONS
Brief 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 score of 70 or higher
- Adequate organ function including neutrophil count ≥1000/mm³, platelet count ≥100,000/mm³, lymphocyte count ≥300/μL, creatinine clearance ≥50 mL/min/1.73m², bilirubin ≤1.5 times upper limit, liver enzymes ≤3 times upper limit, left ventricular ejection fraction ≥50%, and adequate lung function
- Confirmed EGFRvIII positive glioblastoma by certified lab testing
- MGMT promoter unmethylated or methylation index less than 3
- Completed standard external beam radiotherapy as initial treatment
- Able to complete E-SYNC T cell infusion within 12 weeks after radiotherapy
- Off systemic steroids for at least 3 days prior to leukapheresis
- Willing to provide informed consent for apheresis and study treatment
You will not qualify if you...
- Treatment with investigational agents or chemotherapy targeting glioblastoma within 4 weeks prior to study registration (with some exceptions)
- Pregnant or lactating females; females of childbearing potential must have a negative pregnancy test
- Known addiction to alcohol or illicit drugs
- Prior treatment with any EGFR-targeting therapy
- Presence of leptomeningeal dissemination
- Immune system disorders such as HIV or autoimmune diseases requiring systemic immunosuppression
- Active hepatitis B or C infection
- Prior solid organ or bone marrow transplantation
- Uncontrolled illness including active infection, heart failure, unstable angina, cardiac arrhythmia, second cancer under treatment, or psychiatric/social issues limiting compliance
- Unable to return for follow-up visits or required toxicity assessments
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks from leukapheresis through infusion and initial monitoring
Participants undergo leukapheresis to collect cells for manufacturing E-SYNC T cells. They receive cyclophosphamide and fludarabine IV on days -5, -4, and -3 followed by a single IV infusion of E-SYNC T cells on day 0.
1 leukapheresis visit, 3 drug administration visits, and 1 infusion visit
Duration - Approximately 2 weeks
Participants in cohort 2 undergo standard of care surgical resection of tumor tissue between days 14 and 28 after infusion and are monitored for safety and treatment response.
1 hospital admission for surgery
Duration - Up to 15 years
Participants are followed up for safety, immune response, and survival assessments after completion of treatment.
Visits on days 1, 3, 7, 10, 14, 21, 28; then every 4 weeks until week 24; every 8 weeks until week 48; every 12 weeks until week 96; then every 3 months until year 3; then annually up to 15 years
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
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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