NCT07570862 · Fate Therapeutics
A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis
(RECLAIM-LN)
What this study is about
The primary objective of this trial is to evaluate the effectiveness 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.
View original scientific 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.
Interventions
BIOLOGICAL
FT819
Single Intravenous (IV) infusion of FT819 administered on Day 1
Primary outcome measures
Complete Renal Response (CRR) at Week 26
Time frame: Week 26
Proportion of participants achieving CRR at Week 26, with CRR defined as the achievement of all of the following criteria: * UPCR \<0.5 g/g * Estimated glomerular filtration rate (eGFR) ≥85% of baseline or ≥60 mL/min/1.73 m2 * No use of rescue therapy
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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
- 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: 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. 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 criteria
- 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 compliance with protocol conduct or interpretation of results
Where
- Beverly Hills, California
- Fullerton, California
- Miami, Florida
- Omaha, Nebraska
- Fayetteville, North Carolina
- Dallas, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 17, 2026 · Source of record for eligibility and locations