Actively Recruiting
A Phase 12 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer CAR NK Cell Therapy, in Subjects With Immune-Mediated Diseases
Led by Nkarta, Inc. · Updated on 2026-06-04
240
Participants Needed
17
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating NKX019, an investigational allogeneic CAR NK cell therapy targeting CD19, in adults with various autoimmune diseases. This Phase 12 open-label, multi-center study aims to assess the safety and tolerability of NKX019, as well as preliminary efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity. The study includes participants with systemic sclerosis, idiopathic inflammatory myopathies, ANCA-associated vasculitis, and rheumatoid arthritis. Participants undergo a dose escalation phase following a 33 design to find the recommended dose for further study. Treatment cycles include lymphodepletion with fludarabine and cyclophosphamide, or cyclophosphamide alone for those with low blood cell counts, followed by three doses of NKX019. The study will expand to enroll more participants across different autoimmune conditions based on dose findings. During the study, participants will be monitored closely for adverse events and dose-limiting toxicities, especially within the first 28 days after the first NKX019 dose. Follow-up evaluations include laboratory tests, assessments of lung and muscle function, and immune response tracking for up to two years post-infusion. Researchers will also assess the impact of treatment on background therapies and measure drug levels and immune responses over time.
CONDITIONS
Brief Title
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Signed informed consent and ability to follow study visits and protocol
- Women of childbearing potential must have negative pregnancy tests and agree to birth control or abstinence from 2 weeks before first dose through 1 year after last dose
- Stable prednisone dose (20 mg/day or less) for at least 14 days before screening
- Stable doses of immunosuppressives or immunomodulators for at least 4 weeks before screening
- Kidney function (eGFR) of 45 mL/min/1.73 m2 or higher at screening
- Specific disease criteria for systemic sclerosis, idiopathic inflammatory myopathies, ANCA-associated vasculitis, or rheumatoid arthritis as detailed in the protocol
You will not qualify if you...
- Kidney function (eGFR) less than 45 mL/min/1.73m2
- Currently on or expected to require dialysis during the study
- Previous or planned organ or stem cell transplant during study
- Severe immunodeficiency or receiving chronic immunoglobulin therapy
- Liver disease with elevated bilirubin levels
- Severe lung disease requiring daily steroids or oxygen support
- Severe pulmonary function impairment as defined in protocol
- Bone marrow insufficiency unrelated to autoimmune disease
- Major heart problems including recent heart attack or severe heart failure
- Active bleeding disorders
- Other autoimmune or kidney diseases that interfere with assessments
- Pregnancy, breastfeeding, or inadequate contraception
- Active infections needing treatment or recent infection within 30 days
- Positive tests for HIV, hepatitis B or C, or tuberculosis
- Recent major surgery with ongoing complications
- Recent or current malignancy except treated skin or cervical lesions
- Prior cellular therapies including CAR-T or CAR-NK cells
- Central nervous system autoimmune disease or involvement
- Additional disease-specific exclusions as described in protocol for each autoimmune condition
Research Team
N
Nkarta Central Contact
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