A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer
This study is testing an experimental cellular immunotherapy called BC1, alone and in combination with tislelizumab, for people with metastatic recurrent breast cancer. The BC1 cell line is designed to help your immune system fight cancer. You may be eligible if you have metastatic breast cancer that has continued to grow despite previous treatments. If your cancer is HER2-positive, you must have tried at least two anti-HER2 drugs. If your cancer is HER2-negative but hormone receptor-positive, you must have tried hormonal therapy and at least two other treatments. The main goal is to check the safety of these treatments and see what side effects might occur.
- Study design
- This is an open-label Phase 1/2a study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll 18 participants.
- What's involved
- In the initial phase, you would receive BC1 cell line injections every two weeks for six weeks. Later phases involve BC1 as part of the Bria-OTS regimen (including cyclophosphamide and peginterferon alpha-2a) every three weeks, plus tislelizumab.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored throughout the study period and for an additional four weeks, totaling approximately 16 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Giuseppe Del Priore, MD, MPH · STUDY_CHAIR · BriaCell Therapeutics Corp
- Victoria Chua-Alcala, MD · STUDY_DIRECTOR · Sarcoma Oncology Research Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Safety as assessed by adverse events (AEs), including serious adverse events (SAEs)Throughout study period plus 4 weeks, approximately 16 weeks total
Total number of AEs
- Evaluate the Proportion of Patients with Abnormalities in Safety Laboratory Parameters that occur in patients treated with BC1 and BC1 administered in combination with CPI (tislelizumab)Throughout study period plus 4 weeks, approximately 16 weeks total
To evaluate the safety of BC1 as assessed by: o The Proportion of Patients with Abnormalities in Safety Laboratory Parameters
- Evaluate changes in the electrocardiogram QT interval that occur in patients treated with BC1 and BC1 administered in combination with CPI (tislelizumab). [Safety]Throughout study period plus 4 weeks, approximately 16 weeks total
To evaluate the safety of BC1 as assessed by: o Electrocardiograms (ECG) with measurement of the QT interval
- Evaluate the proportion of patients with abnormal physical examination findings including vital signsThroughout study period plus 4 weeks, approximately 16 weeks total
To evaluate the safety of BC1 as assessed by: o The Proportion of Patients with Abnormalities in Physical Examination Findings and Abnormal Vital Signs