Phase 1/2 Study of NKX019 for Lupus Nephritis and Primary Membranous Nephropathy
This study, called Ntrust-1, is testing an investigational drug called NKX019 for people with autoimmune diseases like Lupus Nephritis and Primary Membranous Nephropathy. NKX019 is a type of cell therapy (allogeneic CD19-Directed CAR NK). You would receive NKX019 after a short treatment with fludarabine and cyclophosphamide, which helps prepare your body for the cell therapy. Researchers want to see how safe NKX019 is and if it causes any side effects. They are also looking at how well it works. This study is open to adults aged 18 to 75. The study plans to enroll about 120 participants, but its current status is unclear.
- Study design
- This is a Phase 1/2, open-label study, meaning both you and your study doctor will know which treatment you are receiving. It involves multiple centers and will enroll about 120 participants.
- What's involved
- You would receive a cycle of treatment including fludarabine and cyclophosphamide, followed by three doses of NKX019. You would need to follow a schedule of study visits and other protocol requirements.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for at least 30 days after your last study treatment, and for clinically significant lab changes until your last follow-up visit.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)
At a glance
Conditions
Where it's being run
19 sites across 13 statesStudy leadership
- Nkarta Study Director · STUDY_DIRECTOR · Nkarta, Inc.
Who to contact
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What this trial measures
- Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]The first 28 days after the first NKX019 dose
Incidence of DLTs will be evaluated
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]From the first administration of NKX019 until the last administration of any study treatment + 30 days
Incidence and severity of treatment-emergent adverse events will be evaluated
- Incidence of clinically significant abnormalities in clinical laboratory assessments [Safety and Tolerability]From the first NKX019 dose until the last follow up visit
Incidence of clinically significant laboratory abnormalities will be evaluated