Phase 12 Study of NKX019 CAR NK Cell Therapy for Adults With Autoimmune Diseases Including Systemic Sclerosis, Inflammatory Myopathies, Vasculitis, and Rheumatoid Arthritis

What this Trial Is About

Researchers are studying NKX019, an investigational allogeneic CD19-directed CAR NK cell therapy, to evaluate its safety and tolerability in adults with various autoimmune diseases. This Phase 12, open-label, multi-center study uses a dose escalation and expansion design to find recommended doses and assess preliminary effects including pharmacokinetics, pharmacodynamics, and immunogenicity. Participants will undergo a treatment cycle starting with lymphodepletion using fludarabine and cyclophosphamide before receiving three doses of NKX019. A modified lymphodepletion regimen using cyclophosphamide alone may be given to participants with low blood cell counts. The study includes dose escalation using a 33 design and subsequent enrollment of more participants at the recommended dose levels. During the study, participants will be closely monitored for side effects, treatment-related toxicities, and immune responses. Researchers will collect data on lung disease, systemic sclerosis, inflammatory muscle diseases, vasculitis, and rheumatoid arthritis up to two years after NKX019 infusion. Safety assessments cover the first 28 days after dosing and continue through 30 days after the last treatment. Total participation duration may extend to two years to observe long-term effects.

A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)