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

Fate Therapeutics

Status and phase: Enrolling; Phase 1

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

Treatments: Drug: Fludarabine; Drug: Bendamustine; Drug: FT819; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06308978

FT819-102

Details and patient eligibility

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), 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.

Enrollment: 244 estimated patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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244 participants in 5 patient groups

Regimen A (Single dose with AMP)

Experimental group

Treatment:

Drug: Cyclophosphamide

Drug: FT819

Drug: Bendamustine

Drug: Fludarabine

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

Experimental group

Treatment:

Drug: FT819

Regimen C (Two-dose with AMP)

Experimental group

Treatment:

Drug: Cyclophosphamide

Drug: FT819

Drug: Bendamustine

Drug: Fludarabine

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

Experimental group

Treatment:

Drug: FT819

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

Experimental group

Treatment:

Drug: FT819