FT839 in Autoimmune Diseases

NCT07800871 · tracked via the Priya Life Science USA tracker

Sponsor

Fate Therapeutics

Phase

Phase 1/2

Started

2026-10

Last updated

2026-09-02

Condition(s) studied

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

Investigational drug(s) / intervention(s)

FT839

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

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

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

Primary outcome measure(s)

Phase 1: Incidence of Dose-limiting Toxicity, Adverse Events, and Serious Adverse Events — From enrollment to the end of the post-treatment follow-up at 2 years
Incidence and severity of dose-limiting Toxicity (DLT)s, adverse event (AE)s, and serious adverse event (SAE)s
Phase 2: Change from baseline in Birmingham Vasculitis Activity Score — From enrollment to the end of the post-treatment follow-up at 2 years
Birmingham Vasculitis Activity Score (BVAS) will be measured to evaluate the efficacy of FT839 in AAV. The BVAS score ranges from 0 to 63, with lower scores indicating better outcomes.
Phase 2: Change from baseline in Manual muscle testing-8 — From enrollment to the end of the post-treatment follow-up at 2 years
Manual muscle testing-8 (MMT-8) will be measured to evaluate the efficacy of FT839 in IIM. The MMT-8 score ranges from 0 to 150, with higher scores indicating better outcomes.
Phase 2: Change from baseline in Disease Activity Score using 28 joint counts and C-reactive protein (a composite measure) — From enrollment to the end of the post-treatment follow-up at 2 years
Disease Activity Score using 28 joint counts and C-reactive protein (DAS28-CRP) will be measured to evaluate the efficacy of FT839 in RA. The validated composite measure DAS28-CRP score ranges from 0.0 to 9.4, with lower scores indicating better outcomes.
Phase 2: Change from baseline in SLE Disease Activity Index 2000 — From enrollment to the end of the post-treatment follow-up at 2 years
SLE Disease Activity Index 2000 (SLEDAI-2K) score will be measured to evaluate the efficacy of FT839 in SLE. The SLEDAI-2K score ranges from 0 to 105, with lower scores indicating better outcomes.
Phase 2: Change from baseline in Modified Rodnan skin score — From enrollment to the end of the post-treatment follow-up at 2 years
Modified Rodnan skin (mRSS) score will be measured to evaluate the efficacy of FT839 in SSc. The mRSS score ranges from 0 to 51, with lower scores indicating better outcomes.

Trial sites (1)

Facility	City	Region	Status
Providence Medical Foundation	Fullerton	California	Recruiting

More Fate Therapeutics trials in the USA

FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors Recruiting

FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors Recruiting

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

A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis Recruiting

FT819 in Subjects With B-cell Malignancies Active, not recruiting

Other trials for the same condition

A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE] Starting soon

A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis Active, not recruiting

Descartes-08 for Patients With Systemic Lupus Erythematosus Active, not recruiting

Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders Recruiting

Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07800871 on ClinicalTrials.gov ↗ ← All trials in the USA