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 TumorsPurpose
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).
Who Can Join
To join this study, there are a few conditions. You must:
- Have an advanced solid tumor that makes high levels of HER2. Examples include breast, non-small cell lung, gastroesophageal junction, stomach, gynecologic, and colorectal cancers.
- Have completed prior anti-cancer treatments at least 2 weeks before getting the study therapy.
- Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
- Be age 18 or older
Contact
For more information or to see if you can join this study, please call Dr. Roisin O’Cearbhaill’s office at 646-608-2091.