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NCT Number: NCT06308978

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.

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Key information

Conditions

Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV) Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Cardiovascular Diseases Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Idiopathic Inflammatory Myositis (IIM) Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Lupus Nephritis Male Urogenital Diseases Muscular Diseases Musculoskeletal Diseases Myositis Nephritis Nervous System Diseases Neuromuscular Diseases Scleroderma, Systemic Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Lupus Erythematosus (SLE) Systemic Sclerosis (SSc) Systemic Vasculitis Urogenital Diseases Urologic Diseases Vascular Diseases Vasculitis

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hôpital La Pitié Salpêtrière, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: FLUDARA

Cyclophosphamide

Drug

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

Other names: CYTOXAN

Bendamustine

Drug

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

Primary outcomes

  1. Number of participants with treatment-emergent adverse events (TEAEs)

    Time frame: Up to approximately 2 years

    The number of participants with TEAEs will be reported.

  2. Number of participants with serious TEAEs

    Time frame: Up to approximately 2 years

    The number of participants with serious TEAEs will be reported.

  3. Number of participants with dose-limiting toxicities (DLTs)

    Time frame: Up to approximately 29 days

    The number of participants with DLTs will be reported.

Secondary outcomes

  1. Plasma concentration of FT819

    Time frame: At designated time points up to approximately 29 days

    The plasma concentration of FT819 will be determined.

  2. Impact of treatment on quality of life

    Time frame: Up to approximately 2 years

    Assess changes in patient-reported health outcomes using the SF-36 survey.

  3. Disease Activity

    Time frame: Up to approximately 2 years

    Evaluate improvements in disease-specific measures, such as:

    • SLE: Reduction in SLEDAI-2K score, rates of achieving DORIS, LLDAS
    • AAV: Proportion of patients achieving remission (BVAS v3) and relapse-free survival.
    • IIM: Proportion of patients achieving Myositis Response Criteria Total Improvement Score (MRC TIS major, moderate, minimal).
    • SSc: Changes in modified Rodnan Skin Score (mRSS) and lung function tests (FVC, DLCO).

  4. Disease Activity in Participants with Lupus Nephritis

    Time frame: Up to approximately 2 years

    Change from baseline in urine protein to creatinine ratio (UPCR)

Study contacts

Contact information is provided by the study sponsor or research team.

Fate Clinical Trials

CONTACT

[email protected]

858-875-1800

Sponsors and collaborators

Lead sponsor

Fate Therapeutics

Industry

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2042
First posted
Mar 13, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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