This proposal uses HER2Bi armed activated T-cells (HER2 BATs) to target breast cancer in
combination with pembrolizumab (PBZ) in women with metastatic breast cancer (MBC). Phase I
will determine a safe dose of the combination of PBZ and HER2 BATs in 3 to 18 patients. In
the phase II portion, an additional 12 patients will be treated at the selected dose to
further evaluate the safety and preliminary efficacy.
Study treatment includes a combination of 8 infusions of BATs using a previously established
schedule and one to three infusions of PBZ (200 mg per dose). PBZ will be added to 8
infusions of BATs in 3 schedules: #1) after the 8th BATs infusion; #2) after the 4th and 8th
BATs infusions; and then, #3) before the 1st and after the 4th and 8th BATs infusions.
Once subjects are determined eligible, white blood cells (lymphocytes) are collected via
leukapheresis procedure. Depending on arm/schedule, about 4-5 weeks later, study treatment
will begin. For HER2 BATs, the white blood cells, specifically T cells, are then mixed with
two proteins - OKT3 and IL-2 -- which activates the cells to multiply. After approximately 14
days in culture, the activated T cells are coated with OKT3 and trastuzumab/Herceptin
(HER2Bi), and washed to remove excess Herceptin in order to produce bispecific antibody armed
T cells (BATs). Cells are then frozen and stored until scheduled to be infused.
Follow-up appointment schedule will include clinic visits 2 weeks, 1 month, 3 months, and 6
months after the last dose of Pembrolizumab.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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