This trial is aiming to examine the safety and effectiveness of an experimental treatment called BPX-063, a CAR-T cell treatment, in patients with advanced HER-2 positive breast cancer. The main outcomes to be measured are the maximum tolerated dose of BPX-603 and the antitumor activity. This trial is being carried out across the United States.
HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). This protein promotes the growth of cancer cells. HER2-positive cancer can be difficult to treat. CAR-T are white blood cells that have been genetically engineered to act as immune proteins to function as cancer therapies.
This trial is examining whether CAR-T therapy BPX-603 could be a treatment option for HER2-positive cancer that has previously been treated unsuccessfully. The main outcomes that are to be measured are the side effects of the therapy and the maximum dose of the therapy, as well as anti-tumor activity.
Who are they looking for?
This trial is looking to recruit 220 patients with HER-2 positive breast cancer. Patients must have a confirmed diagnosis of HER2-positive cancer, and have good organ function.
Patients will be excluded from this trial if they have disease spread to the brain or spine, previous treatment with CAR-T cell therapy, have poor heart health, lung disease, or are HIV-positive. Patients who are pregnant or breastfeeding will also be excluded from this trial.
How will it work
All participants will receive one dose of BPX-603 on day-1 followed by a rimducid (AP1903) infusion weekly until treatment is stopped. Rimiducid is a drug that can switch off CAR-T cells after they have killed cancer cells to stop serious side effects.
Side effects will be measured for 35-days after the BPX-603 infusion. The maximum dose that does not cause serious side effects will be established. Antitumor effects will be evaluated for up to 5 years.