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 conditioning chemotherapy 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) 2024-02-24
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
Public contact
Email FateTrialDisclosure@fatetherapeutics.com
Public email FateTrialDisclosure@fatetherapeutics.comFateTrialDisclosure@fatetherapeutics.com
First name Fate Trial Disclosure
Last name Fate Trial Disclosure
Phone +1 866-875-1800
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