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 Xref MGI.; 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.
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