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NCT06186401
Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T Cells
Conditions: EGFR Gene Mutation, Glioblastoma, MGMT-Unmethylated Glioblastoma, Recurrent Glioblastoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 20
Sponsor: Hideho Okada, MD, PhD
Location: University of California, San Francisco San Francisco California
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.
Eligibility Criteria
Inclusion Criteria:
* Inclusion Criteria for Cohort 1:
1. Age \>= 18 years.
2. Karnofsky performance status (KPS) score of \>=70.
3. All participants must have adequate organ function defined as:
1. Peripheral absolute neutrophil count \>=1000/mm\^3.
2. Platelet count \>=100,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
3. Absolute lymphocyte count (ALC) \>= 300/μL and/or Cluster of differentiation 3 (CD3) count of \>=150/μL.
4. Creatinine clearance or radioisotope glomerular filtration rate \>= 50 mL/min/1.73m\^2.
5. Total Bilirubin \
Source: ClinicalTrials.gov (NCT06186401). StuddyBuddy aggregates publicly available trial information.