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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A (Single dose with AMP) | Experimental |
| |
| Regimen B (Single-dose without AMP, with background therapy) | Experimental |
| |
| Regimen C (Two-dose with AMP) | Experimental |
| |
| Regimen D (Two-dose without AMP, with background therapy) | Experimental |
| |
| Regimen B1 (Single-dose without AMP, background therapy temporarily suspended) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FT819 | Drug | FT819 will be administered as intravenous (IV) infusion at planned dose levels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) | The number of participants with TEAEs will be reported. | Up to approximately 2 years |
| Number of participants with serious TEAEs | The number of participants with serious TEAEs will be reported. | Up to approximately 2 years |
| Number of participants with dose-limiting toxicities (DLTs) | The number of participants with DLTs will be reported. | Up to approximately 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of FT819 | The plasma concentration of FT819 will be determined. | 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fate Clinical Trials | Contact | 858-875-1800 | clinicaltrials@fatetherapeutics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wallace Rheumatic Center | Recruiting | Beverly Hills | California | 90210 | United States | |
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| Fludarabine | Drug | Fludarabine will be administered as an IV infusion at planned dose levels. |
|
|
| Cyclophosphamide | Drug | Cyclophosphamide will be administered as an IV infusion at planned dose levels. |
|
|
| Bendamustine | Drug | Bendamustine will be administered as an IV infusion at planned dose levels. |
|
| Up to approximately 2 years |
| Disease Activity | Evaluate improvements in disease-specific measures, such as:
| Up to approximately 2 years |
| Disease Activity in Participants with Lupus Nephritis | Change from baseline in urine protein to creatinine ratio (UPCR) | Up to approximately 2 years |
| Providence Medical Foundation |
| Recruiting |
| Fullerton |
| California |
| 92835 |
| United States |
| University of California Irvine | Recruiting | Irvine | California | 92868 | United States |
| Children's Hospital Los Angeles Division Of Rheumatology | Recruiting | Los Angeles | California | 90027 | United States |
| University of California San Francisco | Recruiting | San Francisco | California | 94110 | United States |
| University of Florida | Recruiting | Gainesville | Florida | 32610 | United States |
| Nicklaus Children's Hospital | Recruiting | Miami | Florida | 33155 | United States |
| University of Louisville | Recruiting | Louisville | Kentucky | 40202 | United States |
| University of Minnesota Medical School | Recruiting | Minneapolis | Minnesota | 55455 | United States |
| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
| Montefiore Medical Center | Recruiting | New York | New York | 10467 | United States |
| Duke University Health System | Recruiting | Durham | North Carolina | 27705 | United States |
| MetroHealth | Recruiting | Cleveland | Ohio | 44109 | United States |
| University of Oklahoma | Recruiting | Oklahoma City | Oklahoma | 73019 | United States |
| Jefferson Einstein Hospital Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19141 | United States |
| Regional One Health | Recruiting | Memphis | Tennessee | 38103 | United States |
| Hôpital La Pitié Salpêtrière | Recruiting | Paris | 75013 | France |
| Uppsala University | Recruiting | Uppsala | Uppland | 752 37 | Sweden |
| Manchester University NHS Foundation Trust | Recruiting | Manchester | Greater Manchester | M139WL | United Kingdom |
| Cambridge University Hospitals NHS Foundation Trust | Recruiting | Cambridge | CB2 0QQ | United Kingdom |
| University College of London Hospitals NHS Trust (UCLH) | Recruiting | London | NW1 2PQ | United Kingdom |
| ID | Term |
|---|---|
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| D009220 | Myositis |
| D012595 | Scleroderma, Systemic |
| D008180 | Lupus Erythematosus, Systemic |
| D008181 | Lupus Nephritis |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D056647 | Systemic Vasculitis |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003240 | Connective Tissue Diseases |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D003520 | Cyclophosphamide |
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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