FT819 cell therapy for lupus nephritis that has not responded to treatment
Tests FT819 in people with lupus nephritis not helped by other treatments.
Plain-language title generated from the registry record
Registry title: A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis
Key facts
- Where
- Beverly Hills, Cooper City, Dallas, Fayetteville, Fontana, Fullerton, Gainesville, Irvine, Miami, Omaha, and San Francisco, United StatesSee the 12 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 70 years old?
Source: NCT07570862, who can take part
Where in United States
- Wallace Rheumatic Studies CenterBeverly Hills, United StatesTaking people
- GNP ResearchCooper City, United StatesTaking people
- The University of Texas Southwestern Medical CenterDallas, United StatesTaking people
- Cross Creek Medical ClinicFayetteville, United StatesTaking people
- Kaiser Permanente-FontanaFontana, United StatesTaking people
- Providence Medical FoundationFullerton, United StatesTaking people
- University of Florida Clinical Research CenterGainesville, United StatesTaking people
- University of California, IrvineIrvine, United StatesTaking people
- Miami Dermatology and Laser ResearchMiami, United StatesTaking people
- Nicklaus Children's HospitalMiami, United StatesTaking people
- University of Nebraska Medical CenterOmaha, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fate Therapeutics
- Trial code
- NCT07570862
- Record updated
- 14 September 2026
- Original description
The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory moderate-to-severe lupus nephritis, as assessed by the proportion of participants who achieve complete renal response (CRR) at Week 26.Read full original descriptionShow less
A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Refractory Moderate-to-Severe Systemic Lupus Erythematosus With Lupus Nephritis (RECLAIM-LN)
The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory moderate-to-severe lupus nephritis, as assessed by the proportion of participants who achieve complete renal response (CRR) at Week 26.
Inclusion: 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; Positivity for at least one of the following autoantibodies at screening:; Antinuclear antibody (ANA); Anti-double-stranded DNA (anti-dsDNA) or; Anti-Smith antibody; Active disease, defined as:; 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. Evidence of renal involvement, defined as UPCr ≥1 g/g; and c. Moderate-to-severe renal disease with investigator's impression that improvement is possible; Refractory to ≥2 systemic immunosuppressive therapies for the treatment of LN.
Exclusion: 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; 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; History of intolerance or contraindication to bendamustine; Known allergy to the following FT819 components: albumin (human) or DMSO; 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 compliance with protocol conduct or interpretation of results; Evidence of inadequate organ function during the screening period; Receipt of dialysis (hemodialysis or peritoneal dialysis) within 12 weeks of trial intervention; Body weight <30 kg.