NCT06308978 · Fate Therapeutics
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
What this study is about
This is a phase 1 study designed to evaluate the safety, how the drug moves through the body (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 gradually increasing doses stage, followed by an expansion stage to further evaluate the safety and activity of FT819.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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).
Where
- Beverly Hills, California
- Fullerton, California
- Irvine, California
- Los Angeles, California
- San Francisco, California
- Gainesville, Florida
- Miami, Florida
- Louisville, Kentucky
- Minneapolis, Minnesota
- Omaha, Nebraska
- New York, New York
- Durham, North Carolina
And 4 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations