The purpose of this study is to understand the safety and estimate the efficacy of combining anti-cluster of differentiation 3 (CD3) x anti-Epidermal Growth Factor Receptor (EGFR) bispecific antibody fresh peripheral blood mononuclear cells (EGFR FPBMC) for patients with metastatic or unresectable pancreas cancer. Participants receive 8 weekly doses and then 8 more doses every 2 weeks of EGFR FPBMC by intravenous infusion.
Once subjects are determined to be eligible, white blood cells (lymphocytes) are collected via leukapheresis procedure. The T cells in the mononuclear cells are coated with bispecific antibody to activate the T cells and the mononuclear cells are reinfused into the patients so the T cells can multiply and kill tumors. About 72 hours after the leukapheresis procedure, EGFR FPBMC infusions will start. After about 8-9 weeks, participants will have another leukapheresis procedure and then receive doses every 2 weeks for 8 more doses. Before, throughout and following EGFR FPBMC, research blood will be collected to better understand immune response. Disease status will be checked regularly during and after study treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Participants will receive 8 weekly infusions of EGFR FPBMC, then 8 additional infusions every 2 weeks.
University of Virginia
Charlottesville, Virginia, United States
RECRUITINGDose limiting toxicities (DLTs) during the dose escalation phase (during the first 8 infusions only)
As defined in the protocol
Time frame: Through the dose escalation phase (during the first 8 infusions only, about 8 weeks after starting study treatment))
Overall Response Rate
Number/Percentage of participants that have a partial or complete response to study treatment
Time frame: Through the dose escalation phase (during the first 8 infusions only, about 8 weeks after starting study treatment))
Progression free survival
Time from start of treatment to time of progression or death from any cause, whichever occurs first.
Time frame: Through 3 years after last infusion for each participant (a maximum of about 3 1/2 years)
Overall Survival
Time from start of treatment to time of death from any cause.
Time frame: Through 3 years after last infusion for each participant (a maximum of about 3 1/2 years)
Specific cytotoxicity by PBMCs against pancreatic cancer cell lines
In blood samples
Time frame: Before study treatment, about 8-9 weeks into study treatment, then 30-45 days, 6 months and 12 months after completion of study treatment
Development of antibodies to pancreatic cancer antigens
In blood samples
Time frame: Before study treatment, about 8-9 weeks into study treatment, then 30-45 days, 6 months and 12 months after completion of study treatment
Survival of EGFR FPBMCs after multiple infusions
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In blood samples
Time frame: Prior to study treatment, prior to each of the first 5 infusions, (optionally) about 1-2 days after each of the first 8 infusions, and about 8-10 weeks after starting study treatment