Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
NCT06308978 · View on ClinicalTrials.gov ↗
Study 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), 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.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Bendamustine
- DRUG FT819
Study Locations (17)
California
- Providence Medical Foundation — Fullerton
- University of California Irvine — Irvine
- Children's Hospital Los Angeles Division Of Rheumatology — Los Angeles
- University of California San Francisco — San Francisco
Other
- Hôpital La Pitié Salpêtrière — Paris
- Cambridge University Hospitals NHS Foundation Trust — Cambridge
- University College of London Hospitals NHS Trust (UCLH) — London
Minnesota
- University of Minnesota Medical School — Minneapolis
Nebraska
- University of Nebraska Medical Center — Omaha
New York
- Montefiore Medical Center — New York
North Carolina
- Duke University Health System — Durham
Ohio
- MetroHealth — Cleveland
Oklahoma
- University of Oklahoma — Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2024-03-28 |
| Est. Completion | 2042-09-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06308978
The ClinicalTrials.gov registry entry for NCT06308978 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 244 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fate Therapeutics, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Systemic Lupus Erythematosus (SLE) appearing as the primary indexed condition, and to 4 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06308978 reports 17 study locations spanning 12 distinct geographic areas — top geographies include California, Other, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06308978 about?
NCT06308978 is a clinical study titled "A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease". 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 anti...
What is the current status of trial NCT06308978?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 244 participants. The study started on 2024-03-28. Estimated completion is 2042-09-30.
What conditions does trial NCT06308978 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), Idiopathic Inflammatory Myositis (IIM), Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06308978?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Bendamustine (DRUG), FT819 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06308978?
This trial is sponsored by Fate Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06308978 being conducted?
This trial has 17 study locations across California, Minnesota, Nebraska, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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