A Phase 1 Study of FT825 CAR T-Cell Therapy With or Without Cetuximab in People With Solid Tumors

In the U.S.

Full Title

A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors

Purpose

Researchers are assessing different doses of FT825 alone or with cetuximab to treat people with advanced solid tumors. Their tumors have high levels of the HER2 protein. Altered HER2 proteins can fuel cancer growth.

FT825 is a cellular therapy made from cells collected from a healthy donor. The donor cells are genetically modified (changed) to turn them into cells called induced pluripotent stem cells (iPSCs). iPSCs can be made to change into different cell types. In this study, iPSCs are used to make white blood cells called T cells. Some cancers can block T cells from attacking tumor cells.

Researchers will use genetically modified T cells to help them work against cancer cells. These modified T cells are called chimeric antigen receptor (CAR) T cells. Treatments made from them are called CAR T-cell therapies. They are a form of immunotherapy.

If you join this study, you will first get the chemotherapy drugs fludarabine and cyclophosphamide or bendamustine. These medicines help prepare your body for FT825. Some people whose cancer has an EGFR mutation will also receive cetuximab, a standard therapy for many cancers. The treatments are given intravenously (by vein).