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
- Paris, FranceSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
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)
Read by machine on 12 November 2026.
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 France
- Hôpital La Pitié SalpetrièreParis, FranceContact: Fate Clinical TrialsTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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).