NCT07800871 · Fate Therapeutics
FT839 in Autoimmune Diseases
What this study is about
The primary objectives of this trial are to evaluate the safety and how well patients handle the treatment 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.
View original scientific description
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.
Interventions
BIOLOGICAL
FT839
Single Intravenous (IV) infusion of FT839 administered on Day 1 and Day 4
Primary outcome measures
Phase 1: Incidence of Dose-limiting Toxicity, Adverse Events, and Serious Adverse Events
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Fullerton, California
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 2, 2026 · Source of record for eligibility and locations