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Her2-BATS and Pembrolizumab in Metastatic Breast Cancer — Breast-47  

Metastatic Breast Cancer Clinical Trial

Official title:
A Phase I/II Study of Anti-CD3 x Anti-HER2/Neu (Her2Bi) Armed Activated T Cells (ATC) and Pembrolizumab Combination Therapy in Women With Metastatic Breast Cancer

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03272334
Study type Interventional
Source University of Virginia
Contact Ashley Donihee
Phone 14342436377
Email ZWZ6JM@hscmail.mcc.virginia.edu
Status Recruiting
Phase Phase 1/Phase 2
Start date December 29, 2017
Completion date January 30, 2030
View Details
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