FT839 in Autoimmune Diseases

NCT ID
NCT07800871
Registry status
Recruiting
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Fate Therapeutics
Conditions
ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc)

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: An Open-Label, Multicenter, Phase 1/2 Dose-Escalation and Expansion Trial Evaluating the Safety and Efficacy of FT839 in Participants With Autoimmune Diseases

Enrollment: 446 participants (Estimated).

What is being studied

  • Biological: FT839

Who may be eligible

Ages
18 Years to 70 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * Age ≥18 to ≤70 years * Must have active B-cell mediated autoimmune disease (AAV, IIM, RA, SLE, or SSc) confirmed by standard criteria * Moderate to severe disease, requiring at least two prior treatments that were ineffective * Adequate organ function to tolerate treatment * Able to provide informed consent and comply with study procedures Exclusion Criteria: * Diagnosis of more than 1 disease under study (AAV, IIM, RA, SSc, or SLE) or overlap syndrome * Women must not be pregnant or nursing * Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment. * Active or chronic infections * Active or recent malignancies * Prior CAR T-cell therapy or organ transplantation * Known allergies to study treatments * Body weight \<45 kg * Active central nervous system (CNS) symptoms attributable to autoimmune disease or nonmalignant CNS disease within 12 months prior to trial intervention * Receipt of any anti-CD19- or anti-CD20-directed therapy within 6 months prior to trial intervention

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • California, United States: 1

Sample of listed locations

  • Providence Medical Foundation — Fullerton, California, 92835, United States — Recruiting

Study details

Start date
October 1, 2026
Primary completion date
October 1, 2028
Completion date
October 1, 2040
First posted
September 2, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07800871
Registry last updated
September 2, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT07800871 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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