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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

244

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

March 28, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2042

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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