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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
244
FT819 will be administered as intravenous (IV) infusion at planned dose levels.
Fludarabine will be administered as an IV infusion at planned dose levels.
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
Bendamustine will be administered as an IV infusion at planned dose levels.
Wallace Rheumatic Center
Beverly Hills, California, United States
RECRUITINGProvidence Medical Foundation
Fullerton, California, United States
RECRUITINGUniversity of California Irvine
Irvine, California, United States
RECRUITINGChildren's Hospital Los Angeles Division Of Rheumatology
Los Angeles, California, United States
RECRUITINGUniversity of California San Francisco
San Francisco, California, United States
RECRUITINGUniversity of Florida
Gainesville, Florida, United States
RECRUITINGNicklaus Children's Hospital
Miami, Florida, United States
RECRUITINGUniversity of Louisville
Louisville, Kentucky, United States
RECRUITINGUniversity of Minnesota Medical School
Minneapolis, Minnesota, United States
RECRUITINGUniversity of Nebraska Medical Center
Omaha, Nebraska, United States
RECRUITING...and 11 more locations
Number of participants with treatment-emergent adverse events (TEAEs)
The number of participants with TEAEs will be reported.
Time frame: Up to approximately 2 years
Number of participants with serious TEAEs
The number of participants with serious TEAEs will be reported.
Time frame: Up to approximately 2 years
Number of participants with dose-limiting toxicities (DLTs)
The number of participants with DLTs will be reported.
Time frame: Up to approximately 29 days
Plasma concentration of FT819
The plasma concentration of FT819 will be determined.
Time frame: At designated time points up to approximately 29 days
Impact of treatment on quality of life
Assess changes in patient-reported health outcomes using the SF-36 survey.
Time frame: Up to approximately 2 years
Disease Activity
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).
Time frame: Up to approximately 2 years
Disease Activity in Participants with Lupus Nephritis
Change from baseline in urine protein to creatinine ratio (UPCR)
Time frame: Up to approximately 2 years
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