Phase 1/2 Study of NKX019 for Autoimmune Diseases

This study is testing a new treatment called NKX019 for autoimmune diseases like Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Antineutrophil Cytoplasmic Antibody-Associated Vasculitis, and Rheumatoid Arthritis. NKX019 is a type of cell therapy that targets specific cells in your body. Before receiving NKX019, you would get other medications called fludarabine and cyclophosphamide to prepare your body. The main goals of this study are to see how safe NKX019 is and what side effects it might cause. We are also looking at how well it works. You might be able to join if you are between 18 and 75 years old. The study aims to enroll 240 participants, but its current status is unclear.

Study design
This is a Phase 1/2, open-label study, meaning both you and your doctors will know which treatment you are receiving. It will involve a dose escalation phase to find the right dose, followed by an expansion phase with more participants.
What's involved
You would receive a cycle of lymphodepletion medications (fludarabine and cyclophosphamide) followed by three doses of NKX019. You would need to follow a specific study visit schedule and other protocol requirements.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured for the first 28 days after the first NKX019 dose, and for 30 days after the last study treatment.

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NCT06733935

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

Recruiting
PHASE1Ages 18–75InterventionalTreatment
Nkarta, Inc.
~240 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:NKX019FludarabineCyclophosphamide

At a glance

Recruiting sites
17 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Dose-limiting toxicities (DLTs) [Safety and Tolerability]
Measured over The first 28 days after the first NKX019 dose
+1 more outcome measured
Systemic Sclerosis
Idiopathic Inflammatory Myopathies
Antineutrophil Cytoplasmic Antibody-Associated Vasculitis
Rheumatoid Arthritis
18 sites across 12 states
Florida3
New York3
New Jersey2
Texas2
California1
Illinois1
Kansas1
Michigan1
  • Nkarta Study Director · STUDY_DIRECTOR · Nkarta, Inc.

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  • 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