The purpose of this study is to test the safety of Adoptive T-Cell therapy following the Dendritic Cell (DC1) study vaccine given in combination with pepinemab added to standard of care therapy, trastuzumab to help people with HER2 positive breast cancer.
Patients with HER2-positive (HER2+) metastatic breast cancer will be treated with 6 weekly injections of dendritic cell (DC1) vaccines in combination with trastuzumab and pepinemab. Investigators hypothesize these therapies will elicit CD4+ HER2 specific T cell responses. HER2 specific T cells will be expanded ex vivo which will be infused to patients subsequently following lymphodepletion therapy with cyclophosphamide. Trastuzumab and pepinemab will be given as maintenance in addition to booster DC1 vaccines.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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.
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.
Participants will receive pepinemab 20 mg/kg by IV beginning week 1 and continuing every 3 weeks until disease progression or intolerable toxicity.
Moffitt Cancer Center
Tampa, Florida, United States
Maximum Tolerated Dose (MTD) of expanded CD4 T cells
MTD of expanded CD4 T cells after treatment with DC1 vaccines and trastuzumab/pepinemab.
Time frame: Up to 6 months
Overall Response Rate (ORR)
ORR according to RECIST criteria v1.1 and iRECIST of treatment DC1 vaccines and pepinemab/trastuzumab
Time frame: Up to 6 months
Clinical Benefit Rate (CBR) of DC1 vaccines and pepinemab/trastuzumab
To assess the 6-month clinical benefit rate (CBR) according to RECIST criteria v. 1.1 of treatment with DC1 vaccines and pepinemab/trastuzumab
Time frame: at 6 months
Clinical Benefit Rate (CBR) of expanded CD4 T Cells
To assess the 6-month CBR according to RECIST criteria v. 1.1 of treatment with expanded CD4+ T cells following DC1 vaccines and pepinemab/trastuzumab.
Time frame: at 6 months
Progression Free Survival (PFS)
PFS is defined as the length of time from start of treatment to progression or death.
Time frame: Up to 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.