Bria-IMT Clinical Trial for Metastatic Breast Cancer
Updated on September 19, 2025
Trial details
Overview: This trial is testing whether a new cellular immunotherapy regimen called Bria-IMT is better than doctors’ choice of chemotherapy for metastatic or locally recurrent breast cancer that has no standard treatment options available.
The Bria-IMT regimen has three components:
SV-BR-1-GM, an experimental cell line modified to stimulate the body’s immune cells to attack breast cancer cells
Cytoxan (chemical name: cyclophosphamide), a chemotherapy medicine that attacks cancer cells
Interferon, a protein that helps control the immune system’s response to viruses
Phase: Phase III; Phase III trials compare the safety and effectiveness of a new treatment to the current standard of care. Phase III trials are usually large – some involve thousands of people – and are done at many places in the United States and around the world.
Number of people to enroll: 404
ClinicalTrials.gov ID number: NCT06072612
Sponsor of the trial: BriaCell Therapeutics Corporation
Who is the trial for?
This study is enrolling adults diagnosed with metastatic or inoperable locally recurrent breast cancer. (Inoperable locally recurrent breast cancer is cancer that has come back in an area near the breast and can’t be removed with surgery.) The breast cancer must have stopped responding to previous treatments and have no other approved treatment options available.
Why is the trial being done?
The trial is designed to see if an experimental immunotherapy regimen called Bria-IMT — either alone or in combination with the immunotherapy medicine Zynyz (chemical name: retifanlimab-dlwr) — offers better survival than doctors’ choice of chemotherapy in people with metastatic or locally recurrent breast cancer who have no approved treatment options available.
Zynyz is approved by the U.S. Food and Drug Administration (FDA) to treat metastatic or recurrent locally advanced Merkel cell carcinoma, a type of skin cancer.
In the study, people will receive either:
Bria-IMT regimen (which includes the three components noted above) and Zynyz;
Bria-IMT regimen alone; or
Doctors’ choice of chemotherapy, including one or more of the following: carboplatin (brand name: Paraplatin), taxanes, Xeloda (chemical name capecitabine), Gemzar (chemical name: gemcitabine), Navelbine (chemical name: vinorelbine), or Halaven (chemical name: eribulin). If the breast cancer is HER2-positive, the doctor also may choose to prescribe an HER2-targeted therapy.
Specific eligibility requirements
People are eligible for this study if they:
have been diagnosed with metastatic or inoperable locally recurrent breast cancer that has grown during previous treatment.
Learn more details about the eligibility requirements.
People are not eligible for this study if they:
received chemotherapy or immunotherapy or had major surgery within 21 days of when they would receive the first dose of medicine through the clinical trial.
received radiation therapy within 14 days of when they would receive the first dose of medicine through the clinical trial.
Learn more details about the exclusion criteria.
Side effects
In earlier studies, the most common side effects of the Bria-IMT regimen included:
Possible side effects of Zynyz
Read more about the side effects of each chemotherapy drug:
Abraxane (chemical name: albumin-bound or nab-paclitaxel)
Taxol (chemical name: paclitaxel)
Taxotere (chemical name: docetaxel)
Study locations
This trial is being conducted at 70 locations in the United States.
For more information or to enroll
Call Maggie Tomasini, CPM, at 267-946-7346 or email Maggie.Tomasini@PrevailinfoWorks.com.
Call Marcela Salgado, MD, at 1-888-309-1868 or email MSalgado@briacell.com.
This content is made possible, in part, by the BriaCell Therapeutics Corporation.