23 Participants NeededMy employer runs this trial

HER2 FPBMC for Breast and Prostate Cancer

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Overseen ByLaura Livingston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HER2 FPBMC, a type of infusion therapy, for individuals with advanced breast or prostate cancer that has metastasized. The researchers aim to assess the safety and effectiveness of this treatment by administering a series of infusions. They seek participants who have tried other treatments but still experience cancer progression and have visible cancer spots for monitoring. Those with metastatic breast or prostate cancer who have seen progression despite previous treatments may be suitable for this trial. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group, offering participants the chance to contribute to groundbreaking cancer research.

Is there any evidence suggesting that HER2 FPBMC is likely to be safe for humans?

Research shows that treatments using HER2 FPBMC, special immune cells designed to attack cancer cells, have undergone safety testing. In earlier studies, these treatments were generally well-tolerated. Some patients experienced side effects, mostly mild to moderate, such as fatigue and mild reactions during administration. Serious side effects were rare.

Since this trial is in the early stages (Phase 1/2), it primarily focuses on understanding safety, providing limited but hopeful information. Researchers continue to study the treatment's safety, but early results suggest it is manageable for most patients. Prospective participants should discuss potential risks and benefits with their doctor.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for breast and prostate cancer, which often involve chemotherapy, hormone therapy, or targeted drugs like trastuzumab, HER2 FPBMC offers a fresh approach. It leverages fresh peripheral blood mononuclear cells (FPBMC) to potentially stimulate the immune system against cancer cells expressing the HER2 protein. This method is intriguing because it uses the body's own immune cells in a novel way, aiming to enhance the immune response specifically against cancer cells without the broader side effects associated with conventional treatments. Researchers are excited because this approach could offer a more targeted and potentially less toxic option for patients with HER2-positive cancers.

What evidence suggests that HER2 FPBMC might be an effective treatment for metastatic breast or prostate cancer?

Studies have shown promising results for HER2 FPBMC in treating advanced breast cancer. Research indicates that treatments targeting HER2 can be very effective, with about 65.1% of patients experiencing tumor shrinkage. The disease control rate, which measures how well the disease is managed over time, reaches as high as 87%. These numbers suggest that targeting the HER2 protein is a strong strategy for combating certain cancers, including breast and prostate cancer. In this trial, participants will receive HER2 FPBMC, designed to harness the body's immune cells to attack cancer, offering a new approach that builds on the success of existing therapies.16789

Who Is on the Research Team?

PV

Paul Viscuse, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for adults (18+) with metastatic breast or prostate cancer who are in good physical condition, have a life expectancy of at least 3 months, and have adequate blood counts and kidney/liver function. Participants must be willing to follow study procedures.

Inclusion Criteria

1. Provision of signed and dated informed consent form
My doctor expects me to live at least 3 more months and I am fully active or restricted in physically strenuous activity only.
* Absolute lymphocyte count ≥ 400/mm3
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Leukapheresis and Preparation

White blood cells are collected via leukapheresis, and T cells are coated with bispecific antibody

1 week
1 visit (in-person)

Treatment

Participants receive 5 weekly infusions of HER2 FPBMC followed by 4 infusions every other week

13 weeks
9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including disease status checks and immune response analysis

24 weeks
Multiple visits (in-person and virtual)

Long-term Follow-up

Participants are monitored for progression-free survival and overall survival

Up to 3 1/2 years

What Are the Treatments Tested in This Trial?

Interventions

  • HER2 FPBMC

Trial Overview

The study tests the safety and effectiveness of HER2 FPBMC, which uses immune cells armed with special antibodies to target cancer. Patients receive weekly infusions for five weeks, then every other week for four more doses.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: HER2 FPBMCExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+

Citations

HER2 FPBMC in Patients With Metastatic Breast and ...

The purpose of this study is to understand the safety and estimate the efficacy of. Multiple timepoints during and through ~30 days after end of study ...

Real-World Outcome and Prognostic Factors Among HER2 ...

The objective response rate (ORR), disease control rate (DCR), and median progression-free survival (mPFS) of the overall cohort were 65.1%, 87 ...

HER2-Positive Breast Cancer Guide | BCRF

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Wave of Pivotal Data Hits HER2-Positive Breast Cancer Care

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