FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors

General Information
Summary	This is a phase 1 study designed to evaluate the safety, tolerability, and antitumor activity of FT825 (also known as ONO-8250) with or without monoclonal antibody therapy following chemotherapy in participants with advanced human epidermal growth factor receptor 2 (HER2)-positive or other advanced solid tumors. The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT825 in indication-specific cohorts.
Clinical trials phase	Phase 1
Start date (estimated)	2024-01-05
End date (estimated)	2044-05-01
Clinical feature	Label Advanced Malignant Solid Neoplasm Link http://purl.obolibrary.org/obo/NCIT_C129707 Description A malignant solid neoplasm that has spread extensively to other anatomic sites or is no longer responding to treatment.
Administrative Information
NCT number	NCT06241456
ICTRP weblink	https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06241456
Other study identifiers	Name FT825-101
Source weblink	https://clinicaltrials.gov/study/NCT06241456
Sponsors	Fate Therapeutics
Cells
Which differentiated cell type is used	Label T cell Link http://purl.obolibrary.org/obo/CL_0000084 Description A type of lymphocyte whose defining characteristic is the expression of a T cell receptor complex.
Recruitment
Recruitment Status	Recruiting
Estimated number of participants	351