FT819 in Moderate to Severe Active Systemic Lupus Erythematosus

General Information
Summary	This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with auxiliary medicinal product (AMP) in participants with moderate to severe active systemic lupus erythematosus (SLE). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.
Clinical trials phase	Phase 1
Start date (estimated)	2024-03-28
End date (estimated)	2042-09-30
Clinical feature	Label systemic lupus erythematosus Link http://purl.obolibrary.org/obo/DOID_9074 Description A lupus erythematosus that is an inflammation of connective tissue marked by skin rashes, joint pain and swelling, inflammation of the kidneys and inflammation of the tissue surrounding the heart.; Xref MGI.
Administrative Information
NCT number	NCT06308978
ICTRP weblink	https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06308978
Other study identifiers	Name FT819-102
Source weblink	https://clinicaltrials.gov/study/NCT06308978
Regulatory body approval	Name Food and Drug Administration (FDA) Country United States
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	32