Study on BRIA-OTS Cellular Immunotherapy for Advanced Breast Cancer

Sponsor: BriaCell Therapeutics Corporation

Sponsor score: 0

Inactive

ClinicalTrials ID:NCT06471673

Patient Parameters

Parameter	Options

Program Overview

This study is exploring a new treatment called BRIA-OTS cellular immunotherapy for patients with advanced breast cancer that has come back after previous treatments. The trial is divided into two phases. In the first phase, the safety of the BC1 cell line is tested by giving it to patients in increasing doses. If the treatment is safe, the second phase will begin, where patients will receive the BC1 cell line along with other medications, including a checkpoint inhibitor, to see if this combination can help control the cancer.

Description

This clinical trial is testing a new treatment called BRIA-OTS cellular immunotherapy for patients with advanced breast cancer that has returned after previous treatments. The study is divided into two phases. In Phase 1, the safety of the BC1 cell line is tested by giving it to patients in increasing doses. If the treatment is safe, Phase 2 will begin, where patients will receive the BC1 cell line along with other medications, including a checkpoint inhibitor, to see if this combination can help control the cancer.

In the first part of Phase 1, patients receive the BC1 cell line alone. The first patient gets a small dose, and if it's safe, the next patient gets a higher dose. This continues until at least three patients have been safely treated. In the second part of Phase 1, patients receive the BC1 cell line along with other medications every three weeks. The study will carefully monitor patients for any side effects.

In Phase 2, more patients will be treated with the combination of BC1 cells and other medications to see if it helps control the cancer. Imaging tests will be done regularly to check the cancer's response to the treatment. Patients can continue the treatment as long as they are benefiting from it and there are no better treatment options available.

The study will also follow patients for up to two years to see how long they stay on treatment and how long they live after the treatment. The goal is to find out if this new treatment can help control advanced breast cancer that has returned after previous treatments.

Eligibility Criteria

Inclusion Criteria

Have advanced breast cancer that has returned after previous treatments.
Be 18 years or older.
Have a life expectancy of at least 4 months.
Be in good overall health with a performance status of up to 2 on the ECOG scale.
Have stable side effects from previous treatments, with no severe immune-related side effects.
For HER2 positive tumors, must have tried at least two anti-HER2 treatments.
For HER2 negative tumors, must have tried at least two hormone-based treatments.
For triple-negative tumors, must have tried treatments including taxane and platinum-based drugs.
Brain metastases must be stable for at least 4 weeks before starting the study, with no need for steroids for at least 2 weeks.

Exclusion Criteria

Currently receiving other cancer treatments.
Recent chemotherapy or radiation within 3 weeks before starting the study.
Not fully recovered from previous treatment side effects.
Allergic to any study medications or components.
Severe kidney or liver problems.
Heart disease classified as stage 3 or 4.
Moderate or severe fluid buildup around the lungs or heart.
Women who are pregnant or breastfeeding.
Men and women of childbearing potential not using effective birth control.
Have another active cancer or had cancer treatment in the past 24 months.
Have HIV or other immune system disorders.
Taking high doses of steroids or other immune-suppressing medications.
Have severe psychiatric or medical conditions not approved by the study team.
Participating in another clinical trial without approval.

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