This phase I trial studies the side effects and best dose of autologous iC9-GD2-CAR-expressing VZV-specific T lymphocytes (GD2-T cells) when given together with varicella-zoster virus strain Oka/Merck live antigen (varicella zoster virus vaccine), and to see how well they work in treating participants with GD2 positive sarcomas that do not respond to treatment (refractory) or have spread to other places in the body (metastatic). T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Putting a new gene that consists of an antibody that recognizes a protein called GD2 into a participant's own T cells may make them recognize tumor cells and kill them. Giving booster vaccinations with the varicella zoster virus vaccine may stimulate the GD2-T cells and make a stronger immune response.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01953900.
PRIMARY OBJECTIVES:
I. To determine the safety of infusing autologous varicella zoster virus (VZV)-specific T cells engrafted with a GD2-specific chimeric antigen receptor (CAR) combined with vaccination with a commercially available VZV vaccine in patients with advanced GD2-positive sarcomas.
SECONDARY OBJECTIVES:
I. To assess the in vivo persistence of infused T cells using immunoassays and transgene detection.
II. To assess the effects of VZV vaccination on the in vivo expansion and persistence of transgenic VZV-specific T cells.
III. To assess the anti-tumor effects of the infused GD2-specific T cells.
OUTLINE: This is a dose escalation study of GD2-T cells.
Participants receive lower doses of GD2-T cells intravenously (IV) over 1-10 minutes on day 0 and VZV vaccine on day 42. Participants receiving higher doses of GD2-T cells receive VZV vaccine 48 hours prior to receiving GD2-T cells IV on day 0.
Upon completion of study treatment, participants are followed up at 3, 6, 9, 12, 15, and 18 months, every 6 months for 4 years, and then yearly for up to 15 years total.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorLisa Lynn Wang
