Clinical Trials
COURTESY - 
Bria-IMT Clinical Trial for Metastatic Breast Cancer
This phase III trial is for people who have been diagnosed with metastatic or inoperable locally recurrent breast cancer who have received all standard treatment options.
Written by Jen Uscher | Reviewed by Jenni Sheng, MD | Updated on March 24, 2026
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
How Our Immunotherapy Works
We introduce a teaching cell.
Our Bria-IMT® therapeutic cells help the immune system identify
What cancer looks like—safely and clearly.
The immune system wakes up.
Once activated, T-cells learn to seek out and respond
to breast cancer cells with greater accuracy.
Checkpoint inhibitors boost the effect.
When used together, the immune system can stay switched on,
more alert, and more effective.
How Bria-IMT™
and Bria-OTS™
Destroy Cancer Cells
Patient Focus
Every patient has a story, a family, a future.
Our work begins — and ends — with the people we serve. We listen deeply, learn from lived experiences, and design treatments that honor each individual’s journey.
- Information for patients
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- What to expect
- Safety and side-effect guidance
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Clinical Trials Overview
Advancing treatment through compassion and evidence.
Our clinical trials are thoughtfully designed to evaluate safety, effectiveness, and real-world impact.
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BriaCell’s Patented Immunotherapy
Bria-IMT™ (for MBC)
Bria-IMT™ BriaCell is a Phase 3 lead candidate. is a patented, off-the-shelf, cell-based, targeted immunotherapy that activates the patient’s immune system to specifically kill cancer cells without harming other cells.
Upon achieving impressive survival and clinical benefit results in a Phase 2 study, BriaCell is conducting a pivotal Phase 3 study in metastatic breast cancer, which, if successful, could lead to full approval of Bria-IMT™ in combination with an immune checkpoint inhibitor.
Clinical data includes unprecedented activity in heavily pre-treated MBC patients who have failed antibody-drug conjugate therapy and in patients with metastases to the central nervous system.
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW; TSX: BCT) is a clinical stage immuno-oncology company that is developing an entirely new class of targeted cellular immunotherapies to transform cancer care
- Lead drug candidate Bria-IMT™
- Pivotal Phase 3 study underway in advanced metastatic breast cancer (over 40K US deaths/year)
- Awarded Fast Track designation by FDA
- Single agent and combination check point inhibitor (+ CPI) activity
- Up to 2-fold increase in survival compared to comparable patients in the literature
- Unprecedented survival and clinical benefit even in CPI and antibody-drug conjugate (ADC) resistant patients
- Remarkable clinical efficacy data in patients with CNS metastases
- Bria-OTS™ & Bria-OTS+™: Next generation novel cell-based cancer immunotherapy platform
- Off-the-shelf and personalized
- Phase 1/2 bucket trial in breast cancer open with planned extension to prostate cancer, melanoma and lung cancer
- Next generation product candidate for prostate cancer (Bria-PROS+) scheduled to enter clinic in 1H2025
- National Cancer Institute Small Business Innovative Research (SBIR) award
- Experienced Management Team and Board of Directors; Clinical Strategy Team involved in 19 drug approvals.
Off-The-Shelf Personalized Immunotherapy
Bria-OTS™/Bria-OTS+™ (for MBC, prostate cancer, and other cancers)
BriaCell’s next-generation personalized off-the-shelf immunotherapy, Bria-OTS™/Bria-OTS+™, awarded numerous US and international patents and supported by clinical data of its phase 3 lead program, Bria-IMT™, forms the basis of BriaCell’s “OTS” strategy. BriaCell recently initiated patient enrollment in its Phase 1/2 bucket trial in breast/prostate/lung cancer and melanoma.
- Bria-IMT™ monotherapy is most effective in HLA-type-matched patients
- Bria-OTS™ is engineered to express 15 unique HLA types in 4 independent cell lines
- Provides matched treatment to greater than 99% of patients
- A simple saliva test provides HLA-matched personalized off-the-shelf Bria-OTS™ immunotherapy
- HLA-matched off-the-shelf therapy is faster and less costly than other expensive and complex personalized immunotherapies
- BriaCell received a Small Business Innovation Research (SBIR) award from the National Cancer Institute
- Ongoing collaboration with the NCI
- The Bria-BRES™ Phase 1/2 study is open in breast cancer.
- Bucket trial with additional cancer indications planned
- The enhanced version (Bria-OTS+™) scheduled to enter the clinic 1H2025, starting with prostate cancer
