Health Trials

About this trial

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

Qualifiers

Age >= 18 years.

Karnofsky performance status (KPS) score of >=70.

Peripheral absolute neutrophil count >=1000/mm^3.

Platelet count >=100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).

Disqualifiers

Exclusion Criteria for Cohort 1

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, mush be >= 6 weeks from last dose of nitrosourea.

Female participants of reproductive potential who are pregnant or lactating. Female study participants of reproductive potential must have a negative serum pregnancy test as part of eligibility confirmation.

Known addiction to alcohol or illicit drugs.

Trial design

Treatments tested in this trial

  • E-SYNC T Cells
  • Cyclophosphamide (non-investigational)
  • Fludarabine (non-investigational)
  • Leukapheresis
  • Surgical resection

Treatment groups

20 Participants
are divided into 3 treatment groups

Locations

1
University of California, San Francisco94143, San FranciscoCalifornia, United States

Sponsors and collaborators

Hideho Okada, MD, PhD

Lead sponsor

University of California, San Francisco

Sponsor institution

California Institute for Regenerative Medicine (CIRM)

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov