A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer

BC1 cell line is a different experimental, HER-2 positive, allogeneic, whole cell BC cell lines designed to secrete GM-CSF in situ and augment dendritic cell activity. Similar to the SV-BR-1-GM cell line (NCT03328026, IND 10312), the BC cell line is derived from the BC parent cell line, SV-BR-1, which expresses multiple tumor associated antigens (TAAs)

"Biological: BC1~* BC1 inoculation intradermally at 4 sites~Drug: Low dose cyclophosphamide~* Pretreatment with low dose cyclophosphamide 2-3 days prior to BC1 inoculation~Drug: Interferon~* Subjects will receive low dose peginterferon alpha-2a on the same day as cell inoculation.~Drug: Tislelizumab~* CPI treatment will also be given on the same day as cell inoculation."

"Biological: BC1~* BC1 inoculation intradermally at 4 sites~Drug: Low dose cyclophosphamide~* Pretreatment with low dose cyclophosphamide 2-3 days prior to BC1 inoculation~Drug: Interferon~* Subjects will receive low dose peginterferon alpha-2a on the same day as cell inoculation.~Drug: Tislelizumab~* CPI treatment will also be given on the same day as cell inoculation."