Skip to content
Bored Studies
RecruitingPhase 1

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

Fate Therapeutics · NCT06308978

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12–70 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1
Target enrollment
244
US sites recruiting
16
Study start
March 28, 2024
Record last updated
May 22, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: FT819; Fludarabine; Cyclophosphamide; Bendamustine

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria

  • 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.

Key Exclusion Criteria

  • 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).

Recruiting US locations

Study contacts (from the official record)

  • Fate Clinical Trials · 858-875-1800 · clinicaltrials@fatetherapeutics.com
All phase 1 studies in California →
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease (NCT06308978) | Bored Studies