At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- FT819 (drug), Fludarabine (drug), Cyclophosphamide (drug), Bendamustine (drug)
- How long the study runs
- Study runs about 222 months (dates as stated)
- About the drug or intervention
- FT819 — drug: FT819 will be administered as intravenous (IV) infusion at planned dose levels. · Fludarabine — drug: Fludarabine will be administered as an IV infusion at planned dose levels. · Cyclophosphamide — drug: Cyclophosphamide will be administered as an IV infusion at planned dose levels. · Bendamustine — drug: Bendamustine will be administered as an IV infusion at planned dose levels.
- Patient visit burden
- Not specified by the sponsor
In plain English
This is an early-stage (Phase 1) study of a treatment called FT819 in people with autoimmune conditions caused by B-cells (a type of immune cell). These conditions include ANCA-associated vasculitis, idiopathic inflammatory myositis, systemic sclerosis, systemic lupus erythematosus, and lupus nephritis. The study is paid for (sponsored) by Fate Therapeutics.
Who can take part
- Aged 12 to 70 years
- Diagnosed with an active B-cell mediated autoimmune disease (SLE, AAV, IIM or SSc) confirmed by standard criteria
- Disease is moderate to severe and at least two previous treatments have not worked
- Good enough organ function to tolerate treatment
- Able to give informed consent (or assent, with parental consent if under 18) and follow study procedures
- Weigh at least 50 kg (110 lbs)
Who may not be able to
- Pregnant or breastfeeding
- Severe problems with the heart, lungs, liver or kidneys
- Recent or ongoing serious infections
- Active or recent cancer, previous CAR T-cell therapy, or an organ transplant
- Known allergy to the study treatments
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 12 Years to 70 Years
- Who
- All
- Number of participants
- 244
- Started
- 2024-03-28
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for antineutrophilic cytoplasmic antibody (anca)- associated vasculitis (aav)
- • Phase1 - 244 participants
- • 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)
Who can take part?
- • Ages 12 Years to 70 Years
- • Diagnosed with antineutrophilic cytoplasmic antibody (anca)- associated vasculitis (aav)
Where?
- • Manchester - Manchester University NHS Foundation Trust
- • Cambridge - Cambridge University Hospitals NHS Foundation Trust
- • London - University College of London Hospitals NHS Trust (UCLH)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 12 Years - 70 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) confirmed by standard criteria
What the study is looking for
- ✓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: healthy organ to tolerate treatment.
- ✓Consent: Able to provide agreement to take part or assent/obtain parental consent and comply with study procedures.
Who cannot take part
- ✗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.
See the full criteria
Where Is This Study? (3 UK sites)
Manchester University NHS Foundation Trust
Manchester M139WL, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge CB2 0QQ, United Kingdom
University College of London Hospitals NHS Trust (UCLH)
London NW1 2PQ, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825How to Get in Touch
Fate Clinical Trials
Sponsor contactCONTACT