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New treatment option for Lupus Nephritis
Official title A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)
ClinicalTrials.gov ID: NCT06557265
What this study is testing
What is NKX019?
NKX019 is an investigational medicine, being studied as a potential treatment for lupus nephritis.
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
- 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.
- 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
- Signed informed consent form 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...
- Progression despite maximal tolerated doses of renin-angiotensin system (RAS) blockade agents
You likely can't join if
- eGFR \< 45 ml/min/1.73 m\^2
- Currently requiring renal dialysis or expected to require dialysis during the study period
- Previous solid organ or hematopoietic cell transplant or planned transplant within study treatment period
- Congenital or acquired immunodeficiency resulting in severe infection or those receiving chronic immunoglobulin replacement therapy
- Liver disease or dysfunction, including cirrhosis and/or aspartate aminotransferase, alanine aminotransferase, or bilirubin ≥ 3 times the upper limit...
- Pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral steroids, resting hypoxemia (\ 10 pack/year)...
See the full eligibility criteria
Who can join
- General
- Age ≥18 and ≤75
- Signed informed consent form 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 prior to the first dose through 1 year after the last dose
- Progression despite maximal tolerated doses of renin-angiotensin system (RAS) blockade agents
- . For participants taking chronic corticosteroids for management of the disease under study, the prednisone (or equivalent) dose must be ≤20 mg/day at 2 weeks prior to Screening and stable for ≥ 14 days before start of...
- For participants on immunosuppressives or immunomodulators (other than corticosteroids), all doses must be stable for ≥ 4 weeks prior to Screening LN-specific
- Score of 10 or more points on the American College of Rheumatology (ACR) 2019 classification criteria for SLE
- Active biopsy proven lupus nephritis Class III or Class IV without Class V overlap using the 2018 International Society of Nephrology and Renal Pathology Society (ISN/RPS) criteria as evidenced on kidney biopsy during...
- Active renal disease as defined by urinary protein:creatinine ratio (UPCR) ≥ 1.5 g/g or proteinuria ≥1.5 g/day on a 24-hour collection and ≤ 7 g/day by either measure
- One or more of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti-dsDNA OR positive anti-Smith (anti-Sm)
- Refractory LN defined as having received ≥ 2 prior therapies for LN (immunosuppressant and corticosteroid/or immunomodulatory agent, and corticosteroid at therapeutic range for at least 90 days), and had an inadequate...
- Evidence of pMN by renal biopsy during screening or within 6 months before screening
- Active renal disease at screening defined by spot UPCR ≥ 3.5 g/g or proteinuria ≥ 3.5 g/day on a 24-hour collection
- Presence of primary membranous nephropathy autoantibodies
- Refractory or intolerant to at least 1 induction therapy for pMN (immunosuppressant and corticosteroid or immunomodulatory agent and/corticosteroid) and defined as not achieving a complete remission after 180 days, or...
What rules you out
- eGFR \< 45 ml/min/1.73 m\^2
- Currently requiring renal dialysis or expected to require dialysis during the study period
- Previous solid organ or hematopoietic cell transplant or planned transplant within study treatment period
- Congenital or acquired immunodeficiency resulting in severe infection or those receiving chronic immunoglobulin replacement therapy
- Liver disease or dysfunction, including cirrhosis and/or aspartate aminotransferase, alanine aminotransferase, or bilirubin ≥ 3 times the upper limit of normal
- Pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral steroids, resting hypoxemia (\ 10 pack/year) with active pulmonary disease
- Bone marrow insufficiency unrelated to active underlying autoimmune disease with white blood cell count \< 3,000/mm\^3; hemoglobin levels \< 9 gm/dL absolute neutrophil count \< 1500/mm\^3; platelet count \<...
- Major cardiac disease, abnormalities, or interventions as defined by, but not limited to:
- Uncontrolled angina or unstable life-threatening arrhythmias
- History of myocardial infarction within 12 weeks prior to the first dose of NKX019
- Any prior coronary artery bypass graft surgery
- ≥ Class III New York Heart Association (NYHA) congestive heart failure (CHF), significantly decreased ejection fraction (EF ≤ 40%), or severe cardiac insufficiency.
- Prolongation of the QT interval corrected for heart rate (QTc) (Fridericia) interval of \> 480 msec
- Peripheral artery bypass graft surgery, pulmonary embolism, or other ≥ Grade 2 thrombotic or embolic events within 12 weeks prior to the first dose of NKX019
- Uncontrolled hypertension (systolic BP \> 160mmHg and/or diastolic BP \> 90mmHg) despite therapy
- Active bleeding disorders
- Any overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes (eg, anti-GBM antibody glomerulonephritis or any condition for additional...
- Pregnancy, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions
- Current infection requiring active systemic anti-infective therapy or recent acute infection requiring systemic therapy within 30 days of planned LD
- History of positive HIV antibody or test positive at screening, Hepatitis B or C positive at screening, active tuberculosis (TB) or latent TB requiring suppressive therapy
- Major surgery within 28 days prior to 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, with the exception of basal and squamous cell carcinomas treated by complete excision. Participants with cervical dysplasia that is cervical intraepithelial neoplasia but have...
- Prior cellular therapy including mesenchymal, CAR-T or CAR-NK cells
- Central nervous system (CNS) comorbidity or any autoimmune disease with CNS involvement within 90 days prior to the first dose of NKX019 as well as active CNS lupus within 1 year prior to screening
- Any other acute or chronic medical or psychiatric condition, or known laboratory abnormality that, in the Investigator's opinion, is expected to interfere or impact study participation
- Current participation in another treatment clinical trial a. Potential participants can be considered for enrollment after investigational product washout period of 5 half-lives or 30 days, whichever is longer
- Currently taking or known need for any of the medications prohibited in the study protocol
- Known hypersensitivity or contraindications to the study treatment including LD; or other components such as human serum albumin or dimethyl sulfoxide LN-specific Exclusion Criteria: 1\. Known clinically active...
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Tustin, California, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- Plantation, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- New Orleans, Louisiana, United States
- Worcester, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Summit, New Jersey, United States
- New York, New York, United States
- Stony Brook, New York, United States
- Syracuse, New York, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Parkville, Victoria, Australia
- Manati, Puerto Rico
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 - 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?
Study sites include Little Rock, Arkansas, United States; Tustin, California, United States; Gainesville, Florida, United States; Miami, Florida, United States; Plantation, Florida, United States; Tampa, Florida, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.