BridgeMD
New treatment option for Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis...
Official title A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
ClinicalTrials.gov ID: NCT06308978
What this study is testing
What is FT819?
FT819 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for antineutrophilic cytoplasmic antibody (anca)- associated vasculitis (aav).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 70
You may be able to join if
- 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
You likely can't join if
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Beverly Hills, California, United States
- Fullerton, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- Louisville, Kentucky, United States
- Minneapolis, Minnesota, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- Memphis, Tennessee, United States
- Paris, France
- Uppsala, Uppland, Sweden
- Manchester, Greater Manchester, United Kingdom
- Cambridge, United Kingdom
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beverly Hills, California, United States; Fullerton, California, United States; Irvine, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Gainesville, Florida, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.