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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: Recruiting Phase 1 study of Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc), sponsored by Fate Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The number of participants with TEAEs will be reported.
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 |
What NCT06308978 shows while recruiting
NCT06308978 is an interventional study that assigns participants to a tested intervention. The registered 244 participants enrollment target is mid-sized for trials with a published cap, below the 1,047-participant average among 14 other Systemic Lupus Erythematosus (SLE) trials with a reported enrollment target (77% lower).
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 lists 17 locations in 12 states (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.
Learn More About Clinical Trials
Similar trials for Systemic Lupus Erythematosus (SLE)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06308978's enrollment target sits among peer trials
244 3rd of 14 higher than 11 of 14 other Systemic Lupus Erythematosus (SLE) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus (SLE) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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