This research study is a gene therapy study. In this study, the treatment uses your own blood cells after they are modified (changed) to attack and destroy cancer cells. This research study will test doses of modified blood cells. The study will look at whether each dose is safe, tolerable, and effective in destroying cancer cells. The study will also look at harms and side effects of administering modified blood cells to people with your type of cancer. This treatment is experimental and has not been approved by the Food and Drug Administration (FDA) for treating triple negative breast cancer.
After a consultation with the study team, you will undergo a series of tests to determine if it is safe for you to proceed with participation. If so, your blood cells (lymphocytes) will be collected and the manufacturing process started. During that process, your cells will be altered with the intent of making those cells more effective in killing your breast cancer cells. If your CAR-T cells are successfully made, you will again undergo several tests to make sure it is safe for you to proceed with participation in the treatment portion of the study. If you remain eligible, you'll complete three days of chemotherapy that will prepare our body to better accept the modified cells. 2-3 days after completion of that chemotherapy regimen, you will receive the iC9.CAR.B7-H3 T cells. Both the chemotherapy and CAR-T infusions will occur in an outpatient setting (ie you will not be required to be admitted to the hospital). You will have to stay near the hospital after infusion and will be seen frequently in clinic for follow up assessments that may include lab tests, imaging, or biopsies of your tumor. You will continue follow up visits based on how well you have responded to the study treatment.
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA
Claire Dees
LCCC - Clinical Trials
Clinical or Medical
Interventional
Cancer (Breast)
23-3242