NCT03272334

Her2-BATS and Pembrolizumab in Metastatic Breast Cancer

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	HER2 BATs with Pembrolizumab	8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab

Timeline

• Start date: 2017-12-29
• Primary completion: 2024-11-30
• Completion: 2031-01-01
• First posted: 2017-09-05
• Last updated: 2026-02-27
• Results posted: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study