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.
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.
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.
Sequential
FT819
DrugFT819 will be administered as intravenous (IV) infusion at planned dose levels.
Fludarabine
DrugFludarabine will be administered as an IV infusion at planned dose levels.
Cyclophosphamide
DrugCyclophosphamide will be administered as an IV infusion at planned dose levels.
Bendamustine
DrugBendamustine 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.
Number of participants with serious TEAEs
The number of participants with serious TEAEs will be reported.
Number of participants with dose-limiting toxicities (DLTs)
The number of participants with DLTs will be reported.
Plasma concentration of FT819
The plasma concentration of FT819 will be determined.
Impact of treatment on quality of life
Assess changes in patient-reported health outcomes using the SF-36 survey.
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).
Disease Activity in Participants with Lupus Nephritis
Change from baseline in urine protein to creatinine ratio (UPCR)
Click on the lead sponsor to view all of their trials.
