OncoMatch/Clinical Trials/NCT06186401
Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T Cells
Is NCT06186401 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including E-SYNC T Cells and Cyclophosphamide (non-investigational) for egfr gene mutation.
Treatment: E-SYNC T Cells · Cyclophosphamide (non-investigational) · Fludarabine (non-investigational) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: EGFR EGFRvIII
EGFRvIII+ GBM from most recent surgery, confirmed by a Clinical Laboratory Improvement Amendments (CLIA)-certified lab using a next-generation sequencing panel (Cohort 1); EGFRvIII + H-score of >=250 based on central review (Cohort 2)
Required: MGMT promoter unmethylated or methylation index < 3
MGMT promoter must be unmethylated or with a methylation index < 3
Prior therapy
Must have received: radiation therapy (external beam radiotherapy) — initial therapy
Must have completed at least standard of care (SOC) external beam radiotherapy (EBRT) as initial therapy
Cannot have received: EGFR-targeting therapy
Prior treatment with any Epithelial Growth Factor Receptor (EGFR)-targeting therapy
Cannot have received: investigational agent
Exception: must be >=23 days from last dose of temozolomide (TMZ) or radiotherapy, must be >=6 weeks from last dose of nitrosourea
Participant who has been treated with any investigational agents and chemotherapy targeting GBM <= 4 weeks prior to date of study registration. Exceptions to this include: must be >=23 days from last dose of temozolomide (TMZ) or radiotherapy, must be >= 6 weeks from last dose of nitrosourea.
Cannot have received: chemotherapy targeting GBM
Exception: must be >=23 days from last dose of temozolomide (TMZ) or radiotherapy, must be >=6 weeks from last dose of nitrosourea
Participant who has been treated with any investigational agents and chemotherapy targeting GBM <= 4 weeks prior to date of study registration. Exceptions to this include: must be >=23 days from last dose of temozolomide (TMZ) or radiotherapy, must be >= 6 weeks from last dose of nitrosourea.
Lab requirements
Blood counts
Peripheral absolute neutrophil count >=1000/mm^3; Platelet count >=100,000/mm^3 (transfusion independent, not receiving platelet transfusions for at least 7 days prior to enrollment); Absolute lymphocyte count (ALC) >= 300/μL and/or CD3 count >=150/μL
Kidney function
Creatinine clearance or radioisotope glomerular filtration rate >= 50 mL/min/1.73m^2
Liver function
Total Bilirubin <= 1.5 x ULN except for Gilbert's syndrome; ALT and AST <= 3x ULN
Cardiac function
Left ventricular ejection fraction (LVEF) >= 50% by echocardiogram or MUGA (Cohort 1 and Cohort 2 Step 1); LVEF >= 40% by echocardiogram or MUGA (Cohort 2 Step 2, within last 12 months)
All participants must have adequate organ function defined as: Peripheral absolute neutrophil count >=1000/mm^3; Platelet count >=100,000/mm^3 (transfusion independent, not receiving platelet transfusions for at least 7 days prior to enrollment); Absolute lymphocyte count (ALC) >= 300/μL and/or CD3 count >=150/μL; Creatinine clearance or radioisotope glomerular filtration rate >= 50 mL/min/1.73m^2; Total Bilirubin <= 1.5 x ULN except for Gilbert's syndrome; ALT and AST <= 3x ULN; Left ventricular ejection fraction (LVEF) >= 50% by echocardiogram or MUGA; Adequate pulmonary function, defined as no evidence of dyspnea at rest and pulse oximetry > 92% while breathing room air; Coagulation tests PT and PTT within normal limits unless therapeutically anticoagulated for previous venous thrombosis (Cohort 2 Step 2 only).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, San Francisco · San Francisco, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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