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FT839 in Autoimmune Diseases

NCT07800871 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 446

Last updated 2026-09-02

No results posted yet for this study

Summary

The primary objectives of this trial are to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose of FT839 with or without rituximab and/or background therapy and/or conditioning therapy.

Conditions

  • ANCA-Associated Vasculitis (AAV)
  • Idiopathic Inflammatory Myositis (IIM)
  • Rheumatoid Arthritis (RA)
  • Systemic Lupus Erythematosus (SLE)
  • Systemic Sclerosis (SSc)

Interventions

BIOLOGICAL

FT839

Single Intravenous (IV) infusion of FT839 administered on Day 1 and Day 4

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2028-10-31
Completion
2040-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT07800871 on ClinicalTrials.gov