Clinical trial for Systemic Sclerosis
Official title A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
ClinicalTrials.gov ID: NCT06733935
What this study is testing
What is NKX019?
NKX019 is an investigational drug being studied as a potential treatment for systemic sclerosis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out how safe and tolerable NKX019 is for people with these autoimmune conditions.
- Who it's for
- Adults who have systemic sclerosis, idiopathic inflammatory myopathies, antineutrophil cytoplasmic antibody‑associated vasculitis, or rheumatoid arthritis.
- What's involved
- Participants will receive NKX019 cells and attend scheduled clinic visits for monitoring and blood tests.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- General
- Age ≥18 and ≤75 years
- Signed informed consent and ability to adhere to the study visit schedule and comply with other protocol requirements
- Women of childbearing potential must have negative pregnancy tests at screening and baseline and agree to abstinence or acceptable birth control from...
- Participants taking corticosteroids must be at a stable prednisone (or equivalent) dose ≤20 mg/day for ≥14 days before Screening
You likely can't join if
- Currently requiring or expected to require renal dialysis during the study
- Previous solid organ or hematopoietic cell transplant, or planned transplant during the study treatment period
- Congenital or acquired immunodeficiency resulting in severe infection, or receiving chronic immunoglobulin replacement therapy
- Liver disease or dysfunction, including cirrhosis and/or bilirubin ≥3× the upper limit of normal
- Pulmonary comorbidity (eg, COPD or asthma requiring daily oral steroids), resting hypoxemia (\ 10 pack-years) with active pulmonary disease
- ILD requiring supplemental oxygen therapy, FVC \<45% predicted, or DLCO ≤40% predicted at screening
See the full eligibility criteria
Who can join
- General
- Age ≥18 and ≤75 years
- Signed informed consent and ability to adhere to the study visit schedule and comply with other protocol requirements
- Women of childbearing potential must have negative pregnancy tests at screening and baseline and agree to abstinence or acceptable birth control from 2 weeks before the first dose through 1 year after the last dose
- Participants taking corticosteroids must be at a stable prednisone (or equivalent) dose ≤20 mg/day for ≥14 days before Screening
- Participants on immunosuppressives or immunomodulators (other than corticosteroids) must have stable dosing for ≥4 weeks before Screening
- Meets the 2013 ACR/EULAR classification criteria for SSc
- Severe skin involvement defined as modified Rodnan skin score (mRSS ≥30) or active skin disease (mRSS ≥15 with, within the prior 6 months, an mRSS increase ≥3 units, 1 new body area with ≥2 mRSS units, or 2 new body...
- 10 years or less since the first non-Raynaud's sign or symptom
- Diagnosis of IIM per the 2017 ACR/EULAR Classification Criteria
- One positive myositis antibody (historical)
- Disease activity defined as manual muscle testing (MMT-8) score \<136/150
- Creatine kinase or aldolase ≥1.5×ULN and Clinician Global Assessment ≥2 cm, with evidence of active myositis (MRI, EMG, or biopsy within 6 months) or MDAAT Global Extramuscular Activity Score ≥2 cm
- Meets the 2022 ACR/EULAR classification criteria for Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)
- Relapsed or refractory AAV despite repeated immunosuppressive treatment, or requiring prolonged/repeated unacceptable glucocorticoid doses to maintain disease control
- Positive anti-proteinase-3 (PR3-ANCA) or anti-myeloperoxidase (MPO-ANCA) at screening
- Documented diagnosis of RA, meeting the 2010 ACR/EULAR classification criteria
- Rheumatoid Factor (RF) or Anti-Citrullinated Protein Antibody (ACPA) positive
- CRP \>3 mg/L
- Inadequate response, defined as failure to achieve a clinically meaningful improvement (eg, ACR50 response or DAS28 remaining \>3.2) after ≥12 weeks of therapy with: ≥1 conventional synthetic DMARD (eg, methotrexate...
- Minimum of 6 swollen joint counts (based on the 66-joint count) and 6 tender joint counts (based on the 68-joint count) at Screening (28-joint counts used at Baseline and thereafter) General
What rules you out
- Currently requiring or expected to require renal dialysis during the study
- Previous solid organ or hematopoietic cell transplant, or planned transplant during the study treatment period
- Congenital or acquired immunodeficiency resulting in severe infection, or receiving chronic immunoglobulin replacement therapy
- Liver disease or dysfunction, including cirrhosis and/or bilirubin ≥3× the upper limit of normal
- Pulmonary comorbidity (eg, COPD or asthma requiring daily oral steroids), resting hypoxemia (\ 10 pack-years) with active pulmonary disease
- ILD requiring supplemental oxygen therapy, FVC \<45% predicted, or DLCO ≤40% predicted at screening
- White blood cell count \<3,000/mm³, hemoglobin levels ≤9 g/dL, absolute neutrophil count ≤1,500/mm³, platelets ≤100,000/mm³, or blood transfusion within 60 days before lymphodepletion (LD)
- Major cardiac disease, abnormalities, or interventions (eg, uncontrolled angina, myocardial infarction within 12 weeks, prior coronary artery bypass graft surgery, ≥Class III congestive heart failure (CHF)...
- Active bleeding disorder
- Overlapping autoimmune condition for which the condition or its treatment may affect study assessments or outcomes
- Pregnancy, breastfeeding, or, if of childbearing potential, not using adequate contraception
- Current infection requiring active systemic anti-infective therapy, or a recent acute infection treated systemically within 30 days of planned LD
- History of positive human immunodeficiency virus (HIV) antibody or PCR test, or a positive test at screening, Hepatitis B or C positive at screening, or active or latent tuberculosis requiring suppressive therapy
- Major surgery within 28 days before the first dose of NKX019, or any surgery from which the participant has not recovered or has ongoing complications
- Malignancy within 5 years of screening, except treated basal/squamous cell carcinoma or treated cervical dysplasia with a normal repeat Pap test
- Prior cellular therapy, including mesenchymal, CAR-T, or CAR-NK cells or CD19 directed therapy
- Central nervous system (CNS) comorbidity, including history or presence of seizure disorder, cerebrovascular ischemia/hemorrhage (including transient ischemic attack), dementia, cerebellar disease, or any...
- Any other acute or chronic medical or psychiatric condition, or laboratory abnormality, that in the Investigator's or Sponsor's opinion would increase the risk of participation, interfere with informed consent, study...
- Current participation in another treatment clinical trial; participants may be considered after an investigational product washout of 5 half-lives or 30 days, whichever is longer
- Moderate-to-severe pulmonary arterial hypertension (PAH) on right heart catheterization requiring PAH-specific treatment (well-controlled mild PAH is permitted)
- Gastrointestinal dysmotility requiring total parenteral nutrition
- Renal crisis or pericardial tamponade within 6 months before enrollment
- Current gangrene of a digit
- Severe chronic proximal muscle involvement on MRI (≥15% fibro-fatty replacement or ≥15% muscle atrophy in core muscle groups, or a combined extent \>30%)
- MMT-8 ≤80
- Muscular inflammation or myopathy due to another cause (eg, inclusion body myositis, cancer-associated myositis, amyloid myopathy, muscular dystrophy, metabolic myopathies, or overlap myositis other than with Sjögren's...
- Generalized, severe musculoskeletal or neuro-muscular condition other than IIM
- Immune-mediated necrotizing myopathy
- Alveolar hemorrhage requiring invasive pulmonary ventilation support
- Required dialysis or plasma exchange within 12 weeks before screening
- Any other known disease that may interfere with assessments, including eosinophilic GPA (Churg-Strauss), anti-glomerular basement membrane disease, systemic lupus erythematosus, IgA vasculitis (Henoch-Schönlein)...
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Plantation, Florida, United States
- Tampa, Florida, United States
- Fairway, Kansas, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Hackensack, New Jersey, United States
- Summit, New Jersey, United States
- New York, New York, United States
- Syracuse, New York, United States
- Charlotte, North Carolina, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Plantation, Florida, United States; Tampa, Florida, United States; Fairway, Kansas, United States; Ann Arbor, Michigan, United States; Minneapolis, Minnesota, United States and 6 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.