RecruitingPhase 2NCT07570862

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

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)

Sponsor

Fate Therapeutics

Enrollment

53 participants

Start Date

Jul 27, 2026

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 12 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called FT819 for people with lupus nephritis, lupus nephritis - who class iii, and other related conditions. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 12 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALFT819

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

Locations(12)

Wallace Rheumatic Studies Center

Beverly Hills, California, United States

Kaiser Permanente Fontana

Fontana, California, United States

Providence Medical Foundation

Fullerton, California, United States

University of California Irvine

Irvine, California, United States

University of California San Francisco

San Francisco, California, United States

GNP Research

Cooper City, Florida, United States

University of Florida Clinical Research Center

Gainesville, Florida, United States

Miami Dermatology and Laser Research

Miami, Florida, United States

Nicklaus Children's Hospital

Miami, Florida, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Cross Creek Medical Clinic

Fayetteville, North Carolina, United States

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07570862

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