Actively Recruiting
A Phase 1/2 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With Autoimmune Disease
Led by Nkarta, Inc. · Updated on 2026-06-04
120
Participants Needed
19
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of NKX019, an investigational allogeneic CD19-directed CAR NK cell therapy, in adults with autoimmune diseases such as Lupus Nephritis and Primary Membranous Nephropathy. This Phase 1/2, open-label, multi-center study uses a dose escalation design to find recommended doses and assess preliminary effects, pharmacokinetics, and pharmacodynamics. Participants undergo a treatment cycle starting with lymphodepletion using fludarabine and cyclophosphamide or cyclophosphamide alone if cytopenic, followed by three doses of NKX019. The study uses a "3+3" dose escalation to determine safe dosing and includes dose expansion cohorts. The treatment aims to evaluate the impact of NKX019 on autoimmune disease activity and kidney function. During the study, participants are closely monitored for dose-limiting toxicities, adverse events, and lab abnormalities from the first dose until follow-up. Researchers assess kidney response, disease activity scores, and drug levels in blood for up to two years after infusion. Immunogenicity and effects on background therapies are also evaluated. The total participation time varies based on follow-up assessments and treatment response.
CONDITIONS
Brief 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 18 to 75 years
- Signed informed consent and ability to follow study visits and requirements
- Women of childbearing potential must have negative pregnancy tests and agree to birth control from 2 weeks before first dose through 1 year after last dose
- Disease progression despite maximum tolerated renin-angiotensin system blockade
- Stable corticosteroid dose of 20 mg/day or less for at least 14 days before screening
- Stable doses of other immunosuppressives or immunomodulators for at least 4 weeks before screening
- For Lupus Nephritis: score of 10 or more on ACR 2019 SLE criteria, biopsy-proven active Class III or IV lupus nephritis without Class V overlap, active renal disease with proteinuria 1.5 to 7 g/day, positive ANA or anti-dsDNA or anti-Smith antibodies, refractory to at least 2 prior therapies
- For Primary Membranous Nephropathy: biopsy evidence within 6 months, active renal disease with proteinuria 3.5 g/day or more, presence of disease-specific autoantibodies, refractory or intolerant to at least 1 induction therapy without complete or partial remission within defined timeframes
You will not qualify if you...
- Estimated glomerular filtration rate below 45 ml/min/1.73 m²
- Current or expected need for renal dialysis during study
- Prior or planned solid organ or hematopoietic transplant during treatment period
- Severe immunodeficiency or receiving chronic immunoglobulin therapy
- Liver disease including cirrhosis or liver enzyme levels three times above normal
- Pulmonary diseases requiring daily oral steroids or significant smoking history with active lung disease
- Bone marrow insufficiency with low blood cell counts
- Major cardiac diseases including recent heart attack, severe heart failure, arrhythmias, or prolonged QT interval
- Uncontrolled hypertension despite therapy
- Active bleeding disorders
- Overlapping autoimmune diseases affecting study assessments
- Pregnancy, breastfeeding, or inadequate contraception
- Active infections requiring treatment or recent infections within 30 days
- Positive tests for HIV, hepatitis B or C, or active/latent tuberculosis
- Recent major surgery or ongoing surgical complications
- Cancer within 5 years except certain treated skin or cervical conditions
- Prior cellular therapies like CAR-T or CAR-NK cells
- Central nervous system autoimmune involvement or active CNS lupus
- Other medical or psychiatric conditions affecting participation
- Concurrent participation in another interventional trial without washout
- Use of prohibited medications or known allergies to study treatments
- For Lupus Nephritis: active antiphospholipid antibody syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 28 days
Participants receive lymphodepletion with fludarabine and cyclophosphamide, followed by three doses of NKX019, an investigational CAR NK cell therapy.
Multiple visits for lymphodepletion and three dosing visits for NKX019
Duration - Up to 2 years
Participants are followed for safety, efficacy, and pharmacokinetics assessments for up to 2 years after NKX019 infusion.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 19 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, 32601
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
Parkville, Victoria, Australia, 3050
Actively Recruiting
19
Nkarta Investigational Site
Manati, Puerto Rico, 00674
Actively Recruiting
Research Team
N
Nkarta Central 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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