This phase I/II trial studies the side effects of tumor associated antigen (TAA)-specific T lymphocytes and to see how well it works in treating participants with pancreatic cancer that has spread to other places in the body or can be removed by surgery. Vaccines made from a person's tumor cells may help the body build an effective immune response to kill tumor cells that express a specific antigen.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03192462.
PRIMARY OBJECTIVES:
I. To determine the safety of up to 6 intravenous infusions of multi-antigen-targeted (multiTAA)-specific T cells in pancreatic cancer patients with metastatic, locally advanced unresectable, or resectable disease.
II. To determine the feasibility of completing a total of 6 intravenous infusions of multiTAA-specific T cells to pancreatic cancer patients with metastatic, locally advanced unresectable, or resectable disease.
SECONDARY OBJECTIVES:
I. To evaluate the progression-free and overall survival of patients after multiTAA-specific T cell infusions.
TERTIARY OBJECTIVES:
I. To obtain information on the expansion, persistence and anti-tumor effects of the adoptively-transferred TAA-specific T cells.
II. To determine whether multiTAA-specific T cell infusion enables recruitment of the patients’ endogenous immune system as measured by epitope/antigen spreading.
OUTLINE: Participants are assigned to 1 of 3 groups.
GROUP A: Participants receive multiTAA-specific T cells intravenously (IV) over 1-10 minutes on day 21 of each chemotherapy course starting on course 4 for up to 6 doses in the absence of disease progression or unaccepted toxicity.
GROUP B: Participants receive multiTAA-specific T cells IV over 1-10 minutes monthly for up to 6 doses in the absence of disease progression or unaccepted toxicity.
GROUP C: Participants receive multiTAA-specific T cells IV over 1-10 minutes 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. Participants then receive 5 additional doses occur at monthly intervals beginning 8 weeks post-surgery as on weeks 8, 12, 16, 20, and 24.
After completion of study treatment, participants are followed up at 4, 6, and 8 weeks, 3, 6, 9, and 12 months, and annually for up to 5 years.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorBrandon G Smaglo
