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NCT06308978PHASE1Recruiting

A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease

Fate Therapeutics

Start Date

3/28/2024

Completion Date

9/30/2042

Summary

This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe active systemic lupus erythematosus (SLE) with or without nephritis, antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.

Eligibility Criteria

Age Range: 12 years to 70 years

Key Inclusion Criteria: * Age: 12 to 70 years old. * Diagnosis: Must have active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) confirmed by standard criteria. * Disease Severity: Moderate to severe, requiring at least two prior treatments that were ineffective. * Health Status: Adequate organ function to tolerate treatment. * Consent: Able to provide informed consent or assent/obtain parental consent and comply with study procedures. Key Exclusion Criteria: * Pregnancy/Breastfeeding: Women must not be pregnant or nursing. * Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment. * Active Infections: No recent or ongoing serious infections. * Recent Cancer or Prior Cell Therapy: No active/recent malignancies, prior CAR T-cell therapy, or organ transplant. * Allergies: No known allergies to study treatments. * Weight Restriction: Must weigh at least 50 kg (110 lbs).

Interventions

DRUG

FT819

DRUG

Fludarabine

DRUG

Cyclophosphamide

DRUG

Bendamustine

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Conditions

Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)Idiopathic Inflammatory Myositis (IIM)Systemic Sclerosis (SSc)Systemic Lupus Erythematosus (SLE)Lupus Nephritis

Locations

Wallace Rheumatic Center

Beverly Hills, California 90210

United States

Providence Medical Foundation

Fullerton, California 92835

United States

University of California Irvine

Irvine, California 92868

United States

Children's Hospital Los Angeles Division Of Rheumatology

Los Angeles, California 90027

United States

University of California San Francisco

San Francisco, California 94110

United States

University of Florida

Gainesville, Florida 32610

United States

Nicklaus Children's Hospital

Miami, Florida 33155

United States

University of Louisville

Louisville, Kentucky 40202

United States

University of Minnesota Medical School

Minneapolis, Minnesota 55455

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

Montefiore Medical Center

New York, New York 10467

United States

Duke University Health System

Durham, North Carolina 27705

United States

MetroHealth

Cleveland, Ohio 44109

United States

University of Oklahoma

Oklahoma City, Oklahoma 73019

United States

Jefferson Einstein Hospital Philadelphia

Philadelphia, Pennsylvania 19141

United States

Regional One Health

Memphis, Tennessee 38103

United States

Hôpital La Pitié Salpêtrière

Paris, 75013

France

Uppsala University

Uppsala, Uppland 752 37

Sweden

Manchester University NHS Foundation Trust

Manchester, Greater Manchester M139WL

United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ

United Kingdom

University College of London Hospitals NHS Trust (UCLH)

London, NW1 2PQ

United Kingdom