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

NCT06308978 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2026-05-22

No results posted yet for this study

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

Interventions

DRUG

FT819

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

DRUG

Fludarabine

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

DRUG

Cyclophosphamide

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

DRUG

Bendamustine

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

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-28
Primary Completion
2027-09-30
Completion
2042-09-30
FDA Drug
Yes

Countries

  • United States
  • France
  • Sweden
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06308978 on ClinicalTrials.gov