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RECRUITINGPhase 1INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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), 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.

Who May Be Eligible (Plain English)

Key Who May Qualify: - Age: 12 to 70 years old. - Diagnosis: Must have active B-cell mediated autoimmune conditions (where your immune system attacks your own body) (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: your organs (liver, kidneys, etc.) are working well enough based on blood tests to tolerate treatment. - Consent: Able to provide willing to sign a consent form or assent/obtain parental consent and comply with study procedures. Key Who Should NOT Join This Trial: - 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

DRUG

FT819

FT819 will be administered as intravenous (IV) infusion at planned dose levels.

DRUG

Fludarabine

Fludarabine will be administered as an IV infusion at planned dose levels.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered as an IV infusion at planned dose levels.

DRUG

Bendamustine

Bendamustine will be administered as an IV infusion at planned dose levels.

Locations (17)

Providence Medical Foundation
Fullerton, California, United States
University of California Irvine
Irvine, California, United States
Children's Hospital Los Angeles Division Of Rheumatology
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
University of Minnesota Medical School
Minneapolis, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Montefiore Medical Center
New York, New York, United States
Duke University Health System
Durham, North Carolina, United States
MetroHealth
Cleveland, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Jefferson Einstein Hospital Philadelphia
Philadelphia, Pennsylvania, United States
Regional One Health
Memphis, Tennessee, United States
Hôpital La Pitié Salpêtrière
Paris, France
Uppsala University
Uppsala, Uppland, Sweden
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
University College of London Hospitals NHS Trust (UCLH)
London, United Kingdom