Study on HER2-BATs and Pembrolizumab for Treating Metastatic Breast Cancer

Sponsor: University of Virginia

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03272334

Provider View

This clinical trial is testing a new treatment that combines HER2Bi armed activated T-cells (HER2 BATs) with pembrolizumab (PBZ) to target metastatic breast cancer in women. The study aims to find a safe dose and evaluate the effectiveness of this combination therapy.

Patient Parameters

Program Overview

The study is exploring a new treatment for women with metastatic breast cancer using a combination of HER2Bi armed activated T-cells (HER2 BATs) and pembrolizumab (PBZ). In the first phase, the trial will determine a safe dose for 3 to 18 patients. In the second phase, 12 more patients will receive the treatment at the selected dose to further assess its safety and initial effectiveness. The treatment involves 8 infusions of BATs and 1 to 3 infusions of PBZ, given in different schedules to see which works best.

Description

Once patients are eligible, their white blood cells are collected through a procedure called leukapheresis. About 4-5 weeks later, the treatment begins. The white blood cells, specifically T cells, are activated and multiplied in the lab using proteins OKT3 and IL-2. After about 14 days, these cells are coated with OKT3 and trastuzumab/Herceptin to create bispecific antibody armed T cells (BATs). These cells are then frozen and stored until they are ready to be infused into the patient.

Patients will have follow-up appointments at 2 weeks, 1 month, 3 months, and 6 months after the last dose of pembrolizumab to monitor their health and the treatment's effects.

Eligibility Criteria

Inclusion Criteria

  • Women with confirmed metastatic breast cancer that can be measured and has spread to other parts of the body.
  • Must have at least one tumor that is 10 mm or larger and has not been treated with radiation.
  • HER2 status must be determined, but both positive and negative HER2 statuses are eligible.
  • Must be 18 years or older.
  • Must be able to provide written consent to participate.
  • Must have a good performance status (ECOG 0-1).
  • Must have a life expectancy of at least 3 months.
  • Must be eligible for apheresis, a procedure to collect blood cells.
  • Must have adequate organ function based on specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for 120 days after the last treatment.
  • Must have had at least two previous treatments for metastatic breast cancer.

Exclusion Criteria

  • Cannot have an immune system deficiency or be on immunosuppressive therapy within 7 days before blood cell collection.
  • Cannot have active tuberculosis.
  • Cannot be allergic to pembrolizumab or its ingredients.
  • Must have recovered from previous cancer treatment side effects.
  • Cannot have had another cancer in the past 5 years, except for certain skin cancers or in situ cervical cancer.
  • Cannot have active brain metastases or cancer in the brain lining.
  • Cannot have an active autoimmune disease requiring treatment in the past 2 years.
  • Cannot have active lung inflammation or infection requiring treatment.
  • Cannot have any condition that might interfere with the study or is not in the patient's best interest.
  • Cannot be pregnant or breastfeeding.
  • Cannot have received certain immune therapies before.
  • Cannot have HIV, active hepatitis B, or detectable hepatitis C.
  • Cannot have received a live vaccine within 30 days before blood cell collection.
  • Cannot have significant heart disease or recent heart attack.
  • May be excluded if the study team believes the patient cannot comply with the study requirements.

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