A Phase 1 interventional study of FT819 and Fludarabine in Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM) and Systemic Sclerosis (SSc), sponsored by Fate Therapeutics. Recruiting at 21 sites in 4 countries. Open to participants aged 12 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Fate Therapeutics · Phase 1, Interventional, and Treatment
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.
157 studies on the registry are indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; 75 are open to participants now.
This study's planned enrollment of 244 is above the median of 34 across 116 interventional studies indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis.
Browse Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis studies →Fate Therapeutics is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: FT819 · Drug: Fludarabine · Drug: Cyclophosphamide · Drug: Bendamustine
Drug: FT819
Drug: FT819 · Drug: Fludarabine · Drug: Cyclophosphamide · Drug: Bendamustine
Drug: FT819
Drug: FT819
FT819 will be administered as intravenous (IV) infusion at planned dose levels.
Fludarabine will be administered as an IV infusion at planned dose levels.
Also known as: FLUDARA
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
Also known as: CYTOXAN
Bendamustine will be administered as an IV infusion at planned dose levels.
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
Plan to share: Undecided
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Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis →