A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants with Lupus Nephritis
Research type
Research Study
Full title
A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Refractory Moderate-to-Severe Systemic Lupus Erythematosus With Lupus Nephritis
IRAS ID
1013789
Contact name
Michelle Greenman
Contact email
Sponsor organisation
Fate Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
Lupus nephritis is a serious complication of systemic lupus erythematosus (SLE). SLE is a disease in which the immune system mistakenly attacks the body’s own tissues. When the kidneys are affected, this is called lupus nephritis. It can lead to permanent kidney damage, reduced kidney function, and, in severe cases, kidney failure.
Despite available treatments, many people with lupus nephritis do not respond adequately or continue to experience disease flares and ongoing kidney damage. Therefore, there is a high unmet medical need for more effective and safer treatment options.
The purpose of this study is to test the effectiveness and safety of FT819 (an investigational cell therapy drug) in people with moderate-to-severe SLE with lupus nephritis. This study will also look at how the body processes and responds to FT819 and how it may affect lupus.
Before receiving treatment, participants will undergo a screening period of up to 28 days to confirm they are eligible. Treatment will include bendamustine given on 2 days, and a single intravenous infusion of FT819. Participants will attend regular trial visits for up to 24 months after receiving FT819. During these visits, doctors will monitor how well the kidneys are responding to treatment and track changes in lupus disease activity. After completing the 24-month follow-up period, participants will continue to be monitored for long-term safety for up to 15 years after receiving FT819.
Approximately 53 people are expected to take part in this study globally.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
26/SC/0153
Date of REC Opinion
16 Jul 2026
REC opinion
Further Information Favourable Opinion