Tests FT819 cell therapy in adults and teens with autoimmune diseases
Tests FT819, a cell therapy, in people with lupus, vasculitis, myositis or scleroderma.
Plain-language title generated from the registry record
Registry title: A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
Key facts
- Where
- Beverly Hills, Cleveland, Durham, Fullerton, Gainesville, Irvine, Los Angeles, Louisville, Memphis, Miami, Minneapolis, New York, Oklahoma City, Omaha, Philadelphia, and San Francisco, United StatesSee the 16 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 70 years old?
Source: NCT06308978, who can take part
Where in United States
- Wallace Rheumatic CenterBeverly Hills, United StatesTaking people
- MetroHealthCleveland, United StatesTaking people
- Duke University Health SystemDurham, United StatesTaking people
- Providence Medical FoundationFullerton, United StatesTaking people
- University of FloridaGainesville, United StatesTaking people
- University of California, IrvineIrvine, United StatesTaking people
- Children's Hospital Los Angeles Division Of RheumatologyLos Angeles, United StatesTaking people
- University of LouisvilleLouisville, United StatesTaking people
- Regional One HealthMemphis, United StatesTaking people
- Nicklaus Children's HospitalMiami, United StatesTaking people
- University of Minnesota Medical SchoolMinneapolis, United StatesTaking people
- Montefiore Medical CenterNew York, United StatesTaking people
- University of OklahomaOklahoma City, United StatesTaking people
- University of Nebraska Medical CenterOmaha, United StatesTaking people
- Jefferson Einstein Hospital PhiladelphiaPhiladelphia, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fate Therapeutics
- Trial code
- NCT06308978
- Record updated
- 22 May 2026
- Original 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.Read full original descriptionShow less
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) 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.
Inclusion: 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.
Exclusion: Recent Cancer or Prior Cell Therapy: No active/recent malignancies, prior CAR T-cell therapy, or organ transplant; Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment; Active Infections: No recent or ongoing serious infections; Allergies: No known allergies to study treatments; Pregnancy/Breastfeeding: Women must not be pregnant or nursing; Weight Restriction: Must weigh at least 50 kg (110 lbs).