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Study identifier: NCT06308978 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV) · Idiopathic Inflammatory Myositis (IIM) · Systemic Sclerosis (SSc)  ·  Sponsor: Fate Therapeutics

PhasePhase 1
Planned participants244
Who can joinAll sexes, 12 Years to 70 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Fate Clinical Trials  ·  858-875-1800  ·  clinicaltrials@fatetherapeutics.com

Always discuss trial participation with your own doctor first.

Locations (21)

Wallace Rheumatic CenterBeverly Hills, California, United StatesRecruiting
Providence Medical FoundationFullerton, California, United StatesRecruiting
University of California IrvineIrvine, California, United StatesRecruiting
Children's Hospital Los Angeles Division Of RheumatologyLos Angeles, California, United StatesRecruiting
University of California San FranciscoSan Francisco, California, United StatesRecruiting
University of FloridaGainesville, Florida, United StatesRecruiting
Nicklaus Children's HospitalMiami, Florida, United StatesRecruiting
University of LouisvilleLouisville, Kentucky, United StatesRecruiting
University of Minnesota Medical SchoolMinneapolis, Minnesota, United StatesRecruiting
University of Nebraska Medical CenterOmaha, Nebraska, United StatesRecruiting
Montefiore Medical CenterNew York, New York, United StatesRecruiting
Duke University Health SystemDurham, North Carolina, United StatesRecruiting

+ 9 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06308978