Recruiting
Phase 1

FT819

Sponsor:

Fate Therapeutics

Code:

NCT06308978

Conditions

Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)

Idiopathic Inflammatory Myositis (IIM)

Systemic Sclerosis (SSc)

Systemic Lupus Erythematosus (SLE)

Lupus Nephritis

Eligibility Criteria

Sex: All

Age: 12 - 70

Healthy Volunteers: Not accepted

Interventions

FT819

Fludarabine

Cyclophosphamide

Bendamustine

Study Details

Brief summary:

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.

Conditions

Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)

Idiopathic Inflammatory Myositis (IIM)

Systemic Sclerosis (SSc)

Systemic Lupus Erythematosus (SLE)

Lupus Nephritis

Study ID

NCT06308978

Start date

Mar 28, 2024

Status verified date

May, 2026

Completion date

Sep 30, 2042

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

244 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Regimen A (Single dose with AMP)

experimental: Regimen B (Single-dose without AMP, with background therapy)

experimental: Regimen C (Two-dose with AMP)

experimental: Regimen D (Two-dose without AMP, with background therapy)

experimental: Regimen B1 (Single-dose without AMP, background therapy temporarily suspended)

Interventions

FT819

FT819 will be administered as intravenous (IV) infusion at planned dose levels.

Fludarabine

Fludarabine will be administered as an IV infusion at planned dose levels.

Cyclophosphamide

Cyclophosphamide will be administered as an IV infusion at planned dose levels.

Bendamustine

Bendamustine will be administered as an IV infusion at planned dose levels.

Primary outcome measure

  • Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to approximately 2 years ]
  • Number of participants with serious TEAEs [ Time Frame: Up to approximately 2 years ]
  • Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Up to approximately 29 days ]

Central Contacts and Locations

Central contacts

Fate Clinical Trials

858-875-1800clinicaltrials@fatetherapeutics.com

Locations

Wallace Rheumatic Center

Recruiting

Beverly Hills, California, United States, 90210

Providence Medical Foundation

Recruiting

Fullerton, California, United States, 92835

University of California Irvine

Recruiting

Irvine, California, United States, 92868

Children's Hospital Los Angeles Division Of Rheumatology

Recruiting

Los Angeles, California, United States, 90027

University of California San Francisco

Recruiting

San Francisco, California, United States, 94110

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Nicklaus Children's Hospital

Recruiting

Miami, Florida, United States, 33155

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

University of Minnesota Medical School

Recruiting

Minneapolis, Minnesota, United States, 55455

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Montefiore Medical Center

Recruiting

New York, New York, United States, 10467

Duke University Health System

Recruiting

Durham, North Carolina, United States, 27705

MetroHealth

Recruiting

Cleveland, Ohio, United States, 44109

University of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73019

Jefferson Einstein Hospital Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19141

Regional One Health

Recruiting

Memphis, Tennessee, United States, 38103

More Information

Sponsor

Fate Therapeutics

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • FT819
  • Fate Therapeutics
  • Idiopathic inflammatory myositis (IIM)
  • Systemic lupus erythematosus (SLE)
  • Systemic sclerosis (SSc)
  • Antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV)
  • Allogeneic CAR-T
  • CD19-Targeted Therapy
  • Cell Therapy for Autoimmune Diseases
  • B-Cell Depletion in Autoimmune Disease
  • Phase 1 Clinical Trial
  • Allogeneic CAR cells
  • Autoimmune Diseases
  • A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Diseases
  • Lupus Nephritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Fate Therapeutics on 2026-05-22.