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

May 19, 2026 updated by: Fate Therapeutics
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
244

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Paris, France, 75013
        • Recruiting
        • Hôpital La Pitié Salpêtrière
  • Sweden
    • Uppland
      • Uppsala, Uppland, Sweden, 752 37
        • Recruiting
        • Uppsala University
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • Cambridge University Hospitals NHS Foundation Trust
      • London, United Kingdom, NW1 2PQ
        • Recruiting
        • University College of London Hospitals NHS Trust (UCLH)
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M139WL
        • Recruiting
        • Manchester University Nhs Foundation Trust
  • United States
    • California
      • Beverly Hills, California, United States, 90210
        • Recruiting
        • Wallace Rheumatic Center
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence Medical Foundation
      • Irvine, California, United States, 92868
        • Recruiting
        • University of California Irvine
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital Los Angeles Division Of Rheumatology
      • San Francisco, California, United States, 94110
        • Recruiting
        • University of California San Francisco
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida
      • Miami, Florida, United States, 33155
        • Recruiting
        • Nicklaus Children's Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota Medical School
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
    • New York
      • New York, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University Health System
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • MetroHealth
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73019
        • Recruiting
        • University of Oklahoma
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Recruiting
        • Jefferson Einstein Hospital Philadelphia
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • Regional One Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Age: 12 to 70 years old.
  • Diagnosis: Must have active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) confirmed by standard criteria.
  • Disease Severity: Moderate to severe, requiring at least two prior treatments that were ineffective.
  • Health Status: Adequate organ function to tolerate treatment.
  • Consent: Able to provide informed consent or assent/obtain parental consent and comply with study procedures.

Key Exclusion Criteria:

  • Pregnancy/Breastfeeding: Women must not be pregnant or nursing.
  • Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment.
  • Active Infections: No recent or ongoing serious infections.
  • Recent Cancer or Prior Cell Therapy: No active/recent malignancies, prior CAR T-cell therapy, or organ transplant.
  • Allergies: No known allergies to study treatments.
  • Weight Restriction: Must weigh at least 50 kg (110 lbs).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Regimen A (Single dose with AMP)
Drug: Fludarabine
Fludarabine will be administered as an IV infusion at planned dose levels.
Other Names:
  • FLUDARA
Drug: Cyclophosphamide
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
Other Names:
  • CYTOXAN
Drug: Bendamustine
Bendamustine will be administered as an IV infusion at planned dose levels.
Drug: FT819
FT819 will be administered as intravenous (IV) infusion at planned dose levels.
Experimental: Regimen B (Single-dose without AMP, with background therapy)
Drug: FT819
FT819 will be administered as intravenous (IV) infusion at planned dose levels.
Experimental: Regimen C (Two-dose with AMP)
Drug: Fludarabine
Fludarabine will be administered as an IV infusion at planned dose levels.
Other Names:
  • FLUDARA
Drug: Cyclophosphamide
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
Other Names:
  • CYTOXAN
Drug: Bendamustine
Bendamustine will be administered as an IV infusion at planned dose levels.
Drug: FT819
FT819 will be administered as intravenous (IV) infusion at planned dose levels.
Experimental: Regimen D (Two-dose without AMP, with background therapy)
Drug: FT819
FT819 will be administered as intravenous (IV) infusion at planned dose levels.
Experimental: Regimen B1 (Single-dose without AMP, background therapy temporarily suspended)
Drug: FT819
FT819 will be administered as intravenous (IV) infusion at planned dose levels.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame: Up to approximately 2 years
The number of participants with TEAEs will be reported.
Up to approximately 2 years
Number of participants with serious TEAEs
Time Frame: Up to approximately 2 years
The number of participants with serious TEAEs will be reported.
Up to approximately 2 years
Number of participants with dose-limiting toxicities (DLTs)
Time Frame: Up to approximately 29 days
The number of participants with DLTs will be reported.
Up to approximately 29 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma concentration of FT819
Time Frame: At designated time points up to approximately 29 days
The plasma concentration of FT819 will be determined.
At designated time points up to approximately 29 days
Impact of treatment on quality of life
Time Frame: Up to approximately 2 years
Assess changes in patient-reported health outcomes using the SF-36 survey.
Up to approximately 2 years
Disease Activity
Time Frame: Up to approximately 2 years

Evaluate improvements in disease-specific measures, such as:

  • SLE: Reduction in SLEDAI-2K score, rates of achieving DORIS, LLDAS
  • AAV: Proportion of patients achieving remission (BVAS v3) and relapse-free survival.
  • IIM: Proportion of patients achieving Myositis Response Criteria Total Improvement Score (MRC TIS major, moderate, minimal).
  • SSc: Changes in modified Rodnan Skin Score (mRSS) and lung function tests (FVC, DLCO).
Up to approximately 2 years
Disease Activity in Participants with Lupus Nephritis
Time Frame: Up to approximately 2 years
Change from baseline in urine protein to creatinine ratio (UPCR)
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fate Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2042

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FT819-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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