Tests FT819 cell therapy in adults and teens with autoimmune diseases
Tests FT819, a cell therapy, in people with lupus, vasculitis, myositis or scleroderma.
Key facts
- Who runs it
- Fate Therapeutics
- 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 sitesAlso in 3 other countries, 5 sites
- Trial code
- Registry title
- A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 244 people, planned
- Started
- 28 Mar 2024
- Expected to end
- 30 Sept 2042
- Type of study
- Interventional, 5 groups
- Treatments tested
- FT819
- Fludarabine
- Cyclophosphamide
- Bendamustine
- Record updated
- 22 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 12 to 70 with active, moderate-to-severe lupus, ANCA-associated vasculitis, inflammatory muscle disease (myositis) or systemic sclerosis.
- Age
- 12 to 70 years old.
- Sex
- All sexes can join.
- Disease stage
- Active B-cell mediated autoimmune disease (SLE, AAV, IIM or SSc), moderate to severe.
- Earlier treatment
- At least two earlier treatments that did not work. No prior CAR T-cell therapy or organ transplant.
Main reasons for not taking part
- Pregnant or nursing women
- Significant heart, lung, liver or kidney impairment
- Recent or ongoing serious infection
- Active or recent cancer, prior CAR T-cell therapy or organ transplant
- Weight under 50 kg (110 lbs)
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
Check if you might fit
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?
Where in United States
Also in 3 other countries, 5 sites
- Wallace Rheumatic CenterBeverly Hills, United StatesContact: Fate Clinical TrialsTaking people
- MetroHealthCleveland, United StatesContact: Fate Clinical TrialsTaking people
- Duke University Health SystemDurham, United StatesContact: Fate Clinical TrialsTaking people
- Providence Medical FoundationFullerton, United StatesContact: Fate Clinical TrialsTaking people
- University of FloridaGainesville, United StatesContact: Fate Clinical TrialsTaking people
- University of California, IrvineIrvine, United StatesContact: Fate Clinical TrialsTaking people
- Children's Hospital Los Angeles Division Of RheumatologyLos Angeles, United StatesContact: Fate Clinical TrialsTaking people
- University of LouisvilleLouisville, United StatesContact: Fate Clinical TrialsTaking people
- Regional One HealthMemphis, United StatesContact: Fate Clinical TrialsTaking people
- Nicklaus Children's HospitalMiami, United StatesContact: Fate Clinical TrialsTaking people
- University of Minnesota Medical SchoolMinneapolis, United StatesContact: Fate Clinical TrialsTaking people
- Montefiore Medical CenterNew York, United StatesContact: Fate Clinical TrialsTaking people
- University of OklahomaOklahoma City, United StatesContact: Fate Clinical TrialsTaking people
- University of Nebraska Medical CenterOmaha, United StatesContact: Fate Clinical TrialsTaking people
- Jefferson Einstein Hospital PhiladelphiaPhiladelphia, United StatesContact: Fate Clinical TrialsTaking people
- University of California San FranciscoSan Francisco, United StatesContact: Fate Clinical TrialsTaking people
About the trial
What the trial wants to find out
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.
The 5 groups in the trial
- Regimen A (Single dose with AMP)Treatment being tested
Treatment: FT819, Fludarabine, Cyclophosphamide, and Bendamustine
- Regimen B (Single-dose without AMP, with background therapy)Treatment being tested
Treatment: FT819
- Regimen C (Two-dose with AMP)Treatment being tested
Treatment: FT819, Fludarabine, Cyclophosphamide, and Bendamustine
- Regimen D (Two-dose without AMP, with background therapy)Treatment being tested
Treatment: FT819
- Regimen B1 (Single-dose without AMP, background therapy temporarily suspended)Treatment being tested
Treatment: FT819
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
- Plain-language title
- Tests FT819 cell therapy in adults and teens with autoimmune diseasesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06308978, who can take part
- Publications
- Record updated
- 22 May 2026