28
Participants
Start Date
May 31, 2022
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2026
Dendritic Cell (DC1) Vaccine
Participants will receive a DC1 vaccine injection at 1.0-2.0 x 10\^7 cells, either to groin lymph notes or to tumor if accessible once a week for 3 weeks on days 1, 8 and 15. Participants will receive DC1 vaccine boosters every 3 weeks x 3.
Trastuzumab
Participants will receive trastuzumab 8 mg/kg by IV week 1, then 6 mg/kg by IV beginning week 4 and continuing every 3 weeks until disease progression or intolerable toxicity.
Pepinemab
Participants will receive pepinemab 20 mg/kg by IV beginning week 1 and continuing every 3 weeks until disease progression or intolerable toxicity.
T-Cell therapy
Participants will receive IL-15 expanded CD4 T cells infusion by IV Day 1 at week 8, 2 weeks from last DC1 vaccine, and IL-7 expanded CD4 T cells infusion IV at week 8 day 8.
RECRUITING
Moffitt Cancer Center, Tampa
Vaccinex Inc.
INDUSTRY
H. Lee Moffitt Cancer Center and Research Institute
OTHER