Lupus Nephritis study: FT819
Official title A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis
ClinicalTrials.gov ID: NCT07570862
What this study is testing
What is FT819?
FT819 is an investigational biological treatment being studied for lupus nephritis. FT819 is designed to use modified immune cells to target and remove specific cells that may be causing inflammation in the kidneys.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if FT819 is safe and can help patients reach a complete kidney response after a chemotherapy drug called bendamustine.
- Who it's for
- Adults who have moderate‑to‑severe lupus nephritis that has not responded well to other treatments.
- What's involved
- Participants will receive FT819 after bendamustine and will have regular clinic visits and kidney tests to monitor safety and kidney function.
- Time commitment
- The study lasts 26 weeks, with scheduled visits and tests throughout that period.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 70
You may be able to join if
- Age ≥12 to ≤70 years
- Diagnosis of SLE per EULAR/ACR 2019 classification criteria
- Biopsy-proven proliferative Class III or IV LN, with or without concomitant Class V involvement, based on the 2003/2018 ISN/RPS classification
- Antinuclear antibody (ANA)
- Anti-double-stranded DNA (anti-dsDNA) or
You likely can't join if
- Evidence of inadequate organ function during the screening period
- Active central nervous system (CNS) symptoms attributable to autoimmune disease within 12 months prior to trial intervention
- History of or current renal diseases (other than LN) that, in the opinion of the investigator, could interfere with assessment of LN or confound...
- Receipt of dialysis (hemodialysis or peritoneal dialysis) within 12 weeks of trial intervention
- Irreversible organ damage related to underlying disease (e.g., ESRD) where, in the opinion of the investigator, CD19 CAR T-cell therapy would be...
- History of malignancy in the prior 5 years
See the full eligibility criteria
- Age ≥12 to ≤70 years
- Diagnosis of SLE per EULAR/ACR 2019 classification criteria
- Biopsy-proven proliferative Class III or IV LN, with or without concomitant Class V involvement, based on the 2003/2018 ISN/RPS classification
- Antinuclear antibody (ANA)
- Anti-double-stranded DNA (anti-dsDNA) or
- Anti-Smith antibody
- Active disease, defined as: a. Evidence of SLE activity, defined as either: i. SLEDAI-2K ≥6 or ii. At least 1 BILAG A or 2 BILAG B scores for SLE-related organ involvement; and b.
- Refractory to ≥2 systemic immunosuppressive therapies for the treatment of LN
- Evidence of inadequate organ function during the screening period
- Active central nervous system (CNS) symptoms attributable to autoimmune disease within 12 months prior to trial intervention
- History of or current renal diseases (other than LN) that, in the opinion of the investigator, could interfere with assessment of LN or confound evaluation of disease activity
- Receipt of dialysis (hemodialysis or peritoneal dialysis) within 12 weeks of trial intervention
- Irreversible organ damage related to underlying disease (e.g., ESRD) where, in the opinion of the investigator, CD19 CAR T-cell therapy would be unlikely to benefit the participant
- History of malignancy in the prior 5 years
- Known allergy to the following FT819 components: albumin (human) or DMSO
- History of intolerance or contraindication to bendamustine
- Body weight \<30 kg
- Any medical condition, clinical laboratory abnormality, or nonmedical/social issue that, per investigator or medical monitor judgement, precludes safe participation in and completion of the trial or that could affect...
The study team makes the final eligibility decision.
Where it is enrolling
- Beverly Hills, California, United States
- Fontana, California, United States
- Fullerton, California, United States
- Irvine, California, United States
- San Francisco, California, United States
- Cooper City, Florida, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- Omaha, Nebraska, United States
- Fayetteville, North Carolina, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Beverly Hills, California, United States; Fontana, California, United States; Fullerton, California, United States; Irvine, California, United States; San Francisco, California, United States; Cooper City, Florida, United States and 5 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.