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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Lupus Erythematosus; Lupus Nephritis; Lupus Nephritis - WHO Class IV; SLE - Systemic Lupus Erythematosus; Lupus Nephritis - WHO Class III
• Intervention / Treatment: Biological: FT819

Detailed Description

This is a multicenter, phase 2 single-arm trial designed to evaluate the efficacy and safety of FT819 in participants with moderate-to-severe systemic lupus erythematosus (SLE) with Class III/IV lupus nephritis (LN) (with or without concomitant Class V involvement) refractory to at least 2 immunosuppressive therapies prior to trial intervention.

Participants will undergo a screening period of up to 28 days. Following screening, trial intervention will consist of bendamustine administration followed by a single dose of FT819. Efficacy, safety, and exploratory assessments will be conducted at predefined timepoints through Month 24 of post-treatment follow-up (PTFU). Following completion of these scheduled assessments, participants will continue in long-term follow-up (LTFU) for up to 15 years after FT819 administration to monitor ongoing safety and survival.

Efficacy and disease activity will be assessed using standard LN measures, including complete renal response (CRR) and PRR (partial renal response), as well as clinician-reported outcomes, such as the SLEDAI-2K, BILAG, and PGA, performed at specified timepoints.

• Study Type: Interventional
• Enrollment (Estimated): 53
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fate Clinical Trials; Phone Number: 858-875-1800; Email: clinicaltrials@fatetherapeutics.com
• Study Contact Backup: Name: Natalie Shiff, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

  1. Antinuclear antibody (ANA)
  2. Anti-double-stranded DNA (anti-dsDNA) or
  3. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FT819; FT819, allogeneic T cells derived from a clonal, TCR knockout iPSC line that express CD19-targeted CAR regulated by the TRAC locus, given as a single IV infusion	Biological: FT819; Single Intravenous (IV) infusion of FT819 administered on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRR at Week 52	Proportion of participants who achieve CRR at Week 52	Week 52
CRR at Week 104	Proportion of participants who achieve CRR at Week 104	Week 104
Overall Renal Response	Proportion of participants who achieve an overall renal response, defined as achievement of either CRR or partial renal response (PRR), evaluated at Week 26, Week 52, and Week 104	Up to approximately 2 years
Proportion of participants who achieve PRR at Week 26, Week 52, and Week 104	PRR is defined as achievement of all of the following: ≥50% reduction in UPCr from baseline and to <3 g/g if baseline UPCr ≥3 g/g; eGFR ≥80% of baseline or ≥60 mL/min/1.73 m2; No use of rescue therapy	Up to approximately 2 years
Lupus Low Disease Activity State (LLDAS)	Proportion of participants who achieve lupus low disease activity state (LLDAS) at Week 26, Week 52, and Week 104	Up to approximately 2 years
Definition of Remission in SLE (DORIS)	Proportion of participants who achieve a definition of remission in SLE (DORIS) at Week 26, Week 52, and Week 104	Up to approximately 2 years
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue	Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (adults age ≥18 years) score at Week 26, Week 52, and Week 104	Up to approximately 2 years
Proportion of participants who achieve SLE Responder Index-4 (SRI-4)	Proportion of participants who achieve SLE Responder Index-4 (SRI-4) at Week 26, Week 52, and Week 104	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Fate Therapeutics

Publications and helpful links

Helpful Links

• Corporate Website

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): January 31, 2030

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Systemic Lupus Erythematosus; Lupus Nephritis; Allogeneic CAR T; FT819; Fate Therapeutics; CD19 - targeted therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Lupus Nephritis
• Other Study ID Numbers: FT819-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No