Actively Recruiting
A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)
Led by Nkarta, Inc. · Updated on 2026-05-14
96
Participants Needed
18
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, multi-center, non-randomized, Phase 1/2 study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with active lupus nephritis (LN) or primary membranous nephropathy (pMN).
CONDITIONS
Official Title
A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Disease progression despite maximal tolerated doses of renin-angiotensin system blockade agents
- If taking corticosteroids for disease management, prednisone dose must be 40 mg/day or less and stable for at least 14 days before screening
- Negative SARS-CoV-2 test
- Stable doses of immunosuppressives or immunomodulators (other than corticosteroids) for at least 4 weeks before screening
- For lupus nephritis: score of 10 or more on ACR 2019 classification for SLE
- Active biopsy-proven lupus nephritis Class III or IV (with or without Class V) within 6 months before screening with required activity and chronicity scores
- Active renal disease defined by urinary protein:creatinine ratio of 1.5 g/g or more or proteinuria 1.5 g/day or more
- Positive antinuclear antibodies (ANA) or anti-dsDNA or anti-Smith antibodies
- Refractory lupus nephritis with at least 2 prior therapies and inadequate response after at least 90 days
- For primary membranous nephropathy: biopsy evidence within 6 months before screening
- Active renal disease defined by UPCR 3.5 g/g or more or proteinuria 3.5 g/day or more
- Positive anti-PLA2R antibodies
- Refractory or intolerant to at least one induction therapy without achieving complete remission after 180 days or partial remission after 90 days
You will not qualify if you...
- Estimated glomerular filtration rate (eGFR) below 45 ml/min/1.73 m2
- Currently requiring or expected to require renal dialysis during study
- Previous or planned solid organ or hematopoietic cell transplant during study treatment
- Severe immunodeficiency or receiving chronic immunoglobulin replacement therapy
- Liver disease or dysfunction with enzymes or bilirubin 3 times above normal
- Pulmonary disease requiring daily oral steroids or active pulmonary disease with resting hypoxemia
- Significant smoking history with active pulmonary disease
- Low blood cell counts: WBC below 3000/mm3, hemoglobin below 9 gm/dL, neutrophils below 2000/mm3, or platelets below 100,000/mm3
- Major cardiac disease including recent myocardial infarction, unstable arrhythmias, severe heart failure, prolonged QT interval, or recent thrombotic events
- Uncontrolled hypertension despite therapy
- Active bleeding disorders
- Other autoimmune conditions or kidney diseases that affect study outcomes
- Pregnancy, breastfeeding, or inadequate contraception if of childbearing potential
- Current or recent infection requiring systemic treatment
- Positive HIV, Hepatitis B or C, or active/latent tuberculosis
- Major surgery within 28 days before first treatment dose
- Recent malignancy within 5 years except certain skin cancers and treated cervical dysplasia
- Prior cellular therapy
- CNS disease involvement or active CNS lupus within specified timeframes
- Any acute or chronic medical or psychiatric condition interfering with study participation
- Recent use of disease-modifying therapies or investigational agents within specified windows
- Use or need of prohibited medications
- Known allergies or contraindications to study treatments or components
- For lupus nephritis: known active antiphospholipid antibody syndrome or high-risk profile
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Nkarta Investigational Site
Little Rock, Arkansas, United States, 72201
Actively Recruiting
2
Nkarta Investigational Site
Tustin, California, United States, 92780
Actively Recruiting
3
Nkarta Investigational Site
Gainesville, Florida, United States, 32610
Actively Recruiting
4
Nkarta Investigational Site
Miami, Florida, United States, 33133
Withdrawn
5
Nkarta Investigational Site
Plantation, Florida, United States, 33317
Actively Recruiting
6
Nkarta Investigational Site
Tampa, Florida, United States, 33602
Actively Recruiting
7
Nkarta Investigational Site
Atlanta, Georgia, United States, 30303
Actively Recruiting
8
Nkarta Investigational Site
Chicago, Illinois, United States, 60612
Actively Recruiting
9
Nkarta Investigational Site
New Orleans, Louisiana, United States, 70112
Actively Recruiting
10
Nkarta Investigational Site
Worcester, Massachusetts, United States, 01608
Actively Recruiting
11
Nkarta Investigational Site
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
12
Nkarta Investigational Site
Summit, New Jersey, United States, 07901
Actively Recruiting
13
Nkarta Investigational Site
New York, New York, United States, 10007
Actively Recruiting
14
Nkarta Investigational Site
Stony Brook, New York, United States, 11794
Actively Recruiting
15
Nkarta Investigational Site
Syracuse, New York, United States, 13202
Actively Recruiting
16
Nkarta Investigational Site
Dallas, Texas, United States, 75201
Actively Recruiting
17
Nkarta Investigational Site
Houston, Texas, United States, 77002
Actively Recruiting
18
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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