CAR T Cell Therapy for Breast Cancer

This trial tests a new treatment for individuals with advanced triple-negative breast cancer that cannot be surgically removed. The goal is to determine if huCART-meso cells, a type of modified immune cell therapy, are safe and effective against the cancer. The trial includes two groups, each receiving a different dose of these cells directly into their tumors. Suitable candidates have breast cancer that meets specific criteria, such as being "triple-negative" (not driven by hormones or the HER2 protein) and expressing a protein called mesothelin on their cancer cells. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

The trial does not specify if you need to stop taking your current medications. However, if you are on high-dose corticosteroids or systemic immunosuppressive treatment, you may need to adjust your medication as per the trial's exclusion criteria.

Research has shown that huCART-meso cells have been tested for safety in other studies. In one study, patients tolerated these cells well, and the cells spread in the body without causing serious side effects. However, they were not very effective in treating cancer. Another study examined safety and side effects in patients with a specific type of breast cancer, finding that huCART-meso cells were generally safe to use.

Researchers are excited about huCART-meso cells because they offer a novel approach to treating breast cancer by harnessing the power of the immune system. Unlike traditional treatments like chemotherapy and hormone therapy, which can affect healthy cells, huCART-meso cells are a type of CAR T cell therapy designed to specifically target and attack cancer cells. These engineered cells are administered directly into the tumor, which may enhance their effectiveness and reduce systemic side effects. This targeted action and innovative delivery method could potentially lead to more effective and safer treatment options for patients.

Research shows that huCART-meso cells can target a protein called mesothelin, found on some breast cancer cells. In earlier studies, these meso-CAR-T cells slowed tumor growth. Participants in this trial will receive huCART-meso cells at different dose levels to assess their effectiveness and safety. Patients in previous studies experienced an increase in these cells in their blood, indicating activity. However, findings noted that while the cells were generally safe, they sometimes showed limited effectiveness. Scientists believe targeting mesothelin could help fight breast cancer, especially when combined with other treatments.¹²³⁴⁶