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Phase 1 Study of FT819 for Autoimmune Diseases

This is a Phase 1 study testing a new treatment called FT819 for people with certain autoimmune diseases like Systemic Lupus Erythematosus (SLE), ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), and Systemic Sclerosis (SSc). You might be eligible if you are 12 to 70 years old, have one of these conditions, and your current treatments haven't worked well. The study aims to see how safe FT819 is, how your body handles it, and how well it affects certain immune cells (B-cells). Some participants may also receive other drugs like Fludarabine, Cyclophosphamide, or Bendamustine. The main goal is to track any side effects over about two years. This study is currently unclear about its recruitment status and plans to enroll up to 244 participants.

Study design
This is a Phase 1 interventional study, meaning participants will receive a specific treatment. It will involve a dose-escalation stage followed by an expansion stage, and plans to enroll up to 244 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-emergent adverse events for up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06308978

A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease

Recruiting
PHASE1Ages 12–70InterventionalTreatment
Fate Therapeutics
~244 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:FT819FludarabineCyclophosphamideBendamustine

At a glance

Recruiting sites
21 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-emergent adverse events (TEAEs)
Measured over Up to approximately 2 years
+2 more outcomes measured

Conditions

Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)
Idiopathic Inflammatory Myositis (IIM)
Systemic Sclerosis (SSc)
Systemic Lupus Erythematosus (SLE)
Lupus Nephritis

Explore related trials

Antineutrophilic Cytoplasmic Antibody-Associated VasculitisIdiopathic Inflammatory MyopathySystemic Lupus ErythematosusSystemic Scleroderma

Where it's being run

21 sites across 15 states
California5
Florida2
United Kingdom2
Kentucky1
Minnesota1
Nebraska1
New York1
North Carolina1

Who to contact

Fate Clinical Trials
[email protected]
858-875-1800
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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).

What this trial measures

  • Number of participants with treatment-emergent adverse events (TEAEs)Up to approximately 2 years

    The number of participants with TEAEs will be reported.

  • Number of participants with serious TEAEsUp to approximately 2 years

    The number of participants with serious TEAEs will be reported.

  • Number of participants with dose-limiting toxicities (DLTs)Up to approximately 29 days

    The number of participants with DLTs will be reported.