The purpose of this study is to obtain blood from sarcoma patients to see if researchers can make cells that are able to fight and kill sarcoma cells. If researchers are able to do this, these T cells may be offered back to the patient in the future if the patient is eligible to participate in a treatment research study using these cells. Should this occur, as separate consent will be obtained that will provide much more information about the risks and potential benefits of this treatment. The purpose of this study is also to find the largest safe dose of chimeric T cells, to learn what the side effects are, and to see whether this therapy might help patients with sarcoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00902044.
PRIMARY OBJECTIVES:
I. To determine the safety of one intravenous injection of autologous T cells expressing human epidermal growth factor receptor 2 (HER2)-specific chimeric antigen receptor (CAR) in patients with advanced HER2-positive sarcoma.
SECONDARY OBJECTIVES:
I. To asses the in vivo persistence of infused T cells using immunoassays and transgene detection.
II. To assess the anti-tumor effects of the infused HER2-specific T cells.
OUTLINE: This is a dose-escalation study.
Patients receive ex vivo-expanded HER2-specific T cells intravenously (IV) over 1-10 minutes. Patients achieving stable disease or a response at their 6 week or subsequent evaluations are eligible to receive up to 6 additional doses of ex vivo-expanded HER2-specific T cells at 6 to 12 weeks intervals.
After completion of study treatment, patients are followed up 2, 4 and 6 weeks, and then every three months for a year, every 6 months for 4 years, and then annually for 10 years.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorNabil Ahmed
