RECRUITING

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

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Conditions

Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)Idiopathic Inflammatory Myositis (IIM)Systemic Sclerosis (SSc)Systemic Lupus Erythematosus (SLE)FT819Fate TherapeuticsAntineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV)Allogeneic CAR-TCD19-Targeted TherapyCell Therapy for Autoimmune DiseasesB-Cell Depletion in Autoimmune DiseasePhase 1 Clinical TrialAllogeneic CAR cellsAutoimmune DiseasesA Phase 1 Study of FT819 in B-cell Mediated Autoimmune Diseases

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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), 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.

Official Title

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

Quick Facts

Study Start:2024-03-28
Study Completion:2042-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06308978

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.

Ages Eligible for Study:12 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: 12 to 70 years old.
  2. * Diagnosis: Must have active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) confirmed by standard criteria.
  3. * Disease Severity: Moderate to severe, requiring at least two prior treatments that were ineffective.
  4. * Health Status: Adequate organ function to tolerate treatment.
  5. * Consent: Able to provide informed consent or assent/obtain parental consent and comply with study procedures.
  1. * Pregnancy/Breastfeeding: Women must not be pregnant or nursing.
  2. * Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment.
  3. * Active Infections: No recent or ongoing serious infections.
  4. * Recent Cancer or Prior Cell Therapy: No active/recent malignancies, prior CAR T-cell therapy, or organ transplant.
  5. * Allergies: No known allergies to study treatments.
  6. * Weight Restriction: Must weigh at least 50 kg (110 lbs).

Contacts and Locations

Study Contact

Fate Trial Disclosure
CONTACT
866-875-1800
FateTrialDisclosure@fatetherapeutics.com

Study Locations (Sites)

University of California Irvine
Irvine, California, 92868
United States
Children's Hospital Los Angeles Division Of Rheumatology
Los Angeles, California, 90027
United States
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2024-03-28
Study Completion Date2042-09-30

Study Record Updates

Study Start Date2024-03-28
Study Completion Date2042-09-30

Terms related to this study

Keywords Provided by Researchers

  • FT819
  • Fate Therapeutics
  • Idiopathic inflammatory myositis (IIM)
  • Systemic lupus erythematosus (SLE)
  • Systemic sclerosis (SSc)
  • Antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV)
  • Allogeneic CAR-T
  • CD19-Targeted Therapy
  • Cell Therapy for Autoimmune Diseases
  • B-Cell Depletion in Autoimmune Disease
  • Phase 1 Clinical Trial
  • Allogeneic CAR cells
  • Autoimmune Diseases
  • A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Diseases

Additional Relevant MeSH Terms

  • Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)
  • Idiopathic Inflammatory Myositis (IIM)
  • Systemic Sclerosis (SSc)
  • Systemic Lupus Erythematosus (SLE)