Actively Recruiting
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
Led by Nkarta, Inc. · Updated on 2026-04-03
144
Participants Needed
15
Research Sites
203 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with autoimmune diseases.
CONDITIONS
Official 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 70 years
- For those taking corticosteroids, prednisone (or equivalent) dose must be 40 mg/day or less and stable for at least 14 days before screening
- Immunosuppressive or immunomodulatory drug doses (other than corticosteroids) must be stable for at least 4 weeks before screening
- Meet criteria for systemic sclerosis, idiopathic inflammatory myopathies, or antineutrophil cytoplasmic antibody-associated vasculitis as defined by specific classification guidelines
- For systemic sclerosis, severe or active skin disease or moderate to severe interstitial lung disease with specific clinical features
- Positive anti-nuclear antibody at least twice the upper limit of normal
- Disease duration of 10 years or less since first non-Raynaud's symptom
- Inadequate response or intolerance to at least one prior treatment for systemic sclerosis
- For idiopathic inflammatory myopathies, active muscle disease with specific clinical and laboratory markers
- Refractory disease with failure or intolerance to at least two immunosuppressive therapies including glucocorticoids
- For vasculitis, relapsed or refractory disease despite repeated immunosuppressive treatment or requiring prolonged high-dose steroids
- Positive test for specific antibodies (PR3-ANCA or MPO-ANCA)
- Disease activity meeting specified criteria on Birmingham Vasculitis Activity Score version 3
You will not qualify if you...
- Estimated glomerular filtration rate (eGFR) less than 45 ml/min/1.73m2
- Current or expected need for renal dialysis during the study
- Previous or planned solid organ or hematopoietic cell transplant during treatment period
- Severe immunodeficiency or chronic immunoglobulin replacement therapy
- Liver disease including cirrhosis or bilirubin three times above normal
- Pulmonary diseases requiring daily oral steroids or resting low oxygen saturation
- Significant smoking history with active lung disease
- Interstitial lung disease requiring supplemental oxygen or with severely reduced lung function
- Low white blood cell, hemoglobin, neutrophil, or platelet counts, or recent blood transfusion
- Major heart disease including recent heart attack, unstable angina, severe heart failure, or prolonged QT interval
- Active bleeding disorders
- Overlapping autoimmune conditions affecting study assessments
- Pregnancy, breastfeeding, or inadequate contraception if of childbearing potential
- Current infection requiring systemic treatment or recent acute infection
- Positive HIV or hepatitis B or C tests, active or latent tuberculosis requiring treatment
- Recent major surgery within 28 days before first treatment
- Recent or active malignancy except certain treated skin cancers or cervical dysplasia
- Prior cellular therapy
- Central nervous system autoimmune disease involvement within specified timeframes
- Recent immunosuppressive or immunomodulatory therapy except specified exceptions
- Additional exclusions for systemic sclerosis including severe pulmonary hypertension, gastrointestinal dysmotility requiring parenteral nutrition, positive anti-centromere antibody, recent renal crisis, pericardial tamponade, or gangrene
- Additional exclusions for idiopathic inflammatory myopathies including severe muscle atrophy, low muscle strength score, other causes of muscle inflammation, or severe neuromuscular conditions
- Additional exclusions for vasculitis including alveolar hemorrhage requiring ventilation, recent dialysis or plasma exchange, or other interfering diseases such as lupus or rheumatoid vasculitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Nkarta Investigational Site
Orange, California, United States, 92868
Actively Recruiting
2
Nkarta Investigational Site
Miami, Florida, United States, 33133
Actively Recruiting
3
Nkarta Investigational Site
Plantation, Florida, United States, 33317
Actively Recruiting
4
Nkarta Investigational Site
Chicago, Illinois, United States, 60612
Actively Recruiting
5
Nkarta Investigational Site
Fairway, Kansas, United States, 66205
Actively Recruiting
6
Nkarta Investigational Site
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
7
Nkarta Investigational Site
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
8
Nkarta Investigational Site
Hackensack, New Jersey, United States, 07601
Actively Recruiting
9
Nkarta Investigational Site
Summit, New Jersey, United States, 07302
Actively Recruiting
10
Nkarta Investigational Site
New York, New York, United States, 10007
Actively Recruiting
11
Nkarta Investigational Site
Stony Brook, New York, United States, 11794
Actively Recruiting
12
Nkarta Investigational Site
Syracuse, New York, United States, 13202
Actively Recruiting
13
Nkarta Investigational Site
Dallas, Texas, United States, 75201
Actively Recruiting
14
Nkarta Investigational Site
Houston, Texas, United States, 77002
Actively Recruiting
15
Nkarta Investigational Site
Manati, Puerto Rico, 00674
Actively Recruiting
Research Team
N
Nkarta Central Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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