A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis

NCT07570862 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: FT819-201
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lupus Nephritis; Systemic Lupus Erythematosus; SLE - Systemic Lupus Erythematosus; Lupus Nephritis - WHO Class III; Lupus Nephritis - WHO Class IV

Keywords

FT819; Fate Therapeutics; Allogeneic CAR T; CD19 - targeted therapy; Lupus Nephritis; Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Complete Renal Response (CRR) at 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

  Week 26

Secondary Outcomes (8)

• CRR at Week 52

  Week 52

• CRR at Week 104

  Week 104

• Overall Renal Response

  Up to approximately 2 years

• Proportion of participants who achieve PRR at Week 26, Week 52, and Week 104

  Up to approximately 2 years

• Lupus Low Disease Activity State (LLDAS)

  Up to approximately 2 years

Study Arms (1)

FT819

EXPERIMENTAL

FT819, allogeneic T cells derived from a clonal, TCR knockout iPSC line that express CT19-targeted CAR regulated by the TRAC locus, given as a single IV infusion

Biological: FT819

Interventions

FT819 BIOLOGICAL

Single Intravenous (IV) infusion of FT819 administered on Day 1

FT819

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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
• 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

You may not qualify 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 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

Sponsors & Collaborators

• Fate Therapeutics: lead

Related Links

• Corporate Website

MeSH Terms

Conditions

Lupus Nephritis; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Fate Clinical Trials

CONTACT

858-875-1800; clinicaltrials@fatetherapeutics.com

Natalie Shiff, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm, single group assignment, open-label

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): January 31, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share