Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T Cells
NCT06186401 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-03-16
Summary
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
- EGFR Gene Mutation
- Glioblastoma
- MGMT-Unmethylated Glioblastoma
- Recurrent Glioblastoma
Interventions
- BIOLOGICAL
-
E-SYNC T Cells
Given IV
- DRUG
-
Cyclophosphamide (non-investigational)
Given IV
- DRUG
-
Fludarabine (non-investigational)
Given IV
- PROCEDURE
-
Leukapheresis
Undergo leukapheresis
- PROCEDURE
-
Surgical resection
Undergo surgical resection of tumor tissue
Sponsors & Collaborators
-
California Institute for Regenerative Medicine (CIRM)
collaborator OTHER -
National Cancer Institute (NCI)
collaborator NIH -
Hideho Okada, MD, PhD
lead OTHER
Principal Investigators
-
Jennifer Clarke, MD, MPH · University of California, San Francisco
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-30
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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