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NCT06308978 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
A Phase 1 study of Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc), sponsored by Fate Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 244
- Enrollment target
- 17
- Study locations
NCT06308978 is a Phase 1 study of Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc) that is actively recruiting participants, run by Fate Therapeutics. The registered enrollment target is 244 participants, below the 1,047-participant average among 14 other Systemic Lupus Erythematosus (SLE) trials with a reported enrollment target (77% lower). The trial reports 17 study locations across 12 states.
The verdict
NCT06308978, a Phase 1 study of Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc), is actively recruiting participants, sponsored by Fate Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 244 participants
- Enrollment target
- 17
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 244 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,047-participant average among 14 other Systemic Lupus Erythematosus (SLE) trials with a reported enrollment target (77% lower). The listed sponsor is Fate Therapeutics, which has 22 total studies on file at ClinicalTrials.gov.
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.
NCT06308978 reports 17 study locations spanning 12 distinct geographic areas - top geographies include California, Other, Minnesota.
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).
What interventions are being tested in trial NCT06308978?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Bendamustine (DRUG), FT819 (DRUG).
Who is sponsoring clinical trial NCT06308978?
This trial is sponsored by Fate Therapeutics, which has 22 total clinical trials registered on ClinicalTrials.gov.
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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