A Phase 1 Study of NKX019 in Subjects with Immune-Mediated Disease

Eligibility

Inclusion Criteria:

Age: 18-65 years old at the time of informed consent

eGFR as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of ≥ 45 mL/min/1.73 m2 at screening (Appendix 3).

Systemic Sclerosis (SSc) Inclusion Criteria:

Classified as SSc as per 2013 ACR/EULAR Classification Criteria

Inadequate response or intolerance to at least one treatment, including cyclophosphamide, methotrexate, MMF/mycophenolic acid, nintedanib, rituximab, or tocilizumab

Idiopathic Inflammatory Myopathy (IIM) Key Inclusion Criteria:

Diagnosis of probable or definite (> 55%) IIM according to the 2017 ACR/EULAR Classification Criteria for idiopathic inflammatory myopathies (Lundberg 2017)

Refractory disease defined as ≥ 6 months failure (or intolerance) to at least two immunosuppressive therapies (including glucocorticoids)

ANCA-Associated Vasculitis (AAV) Key Inclusion Criteria:

Meeting the 2022 ACR/EULAR classification criteria for GPA (Robson 2022) or MPA (Suppiah 2022)

Relapsed or refractory AAV despite repeated treatment with immunosuppressive agents or requiring prolonged and/or repeated courses of unacceptable doses of glucocorticoids to maintain disease control

Key Exclusion Criteria:

Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period

Previous solid organ or hematopoietic cell transplant or planned transplant within study treatment period

Underlying liver disease or dysfunction, including cirrhosis and/or bilirubin ≥ 3.0 times the upper limit of normal

Major cardiac disease, abnormalities, or interventions as defined by, but not limited to:
a. Uncontrolled angina or unstable life-threatening arrhythmias
b. History of myocardial infarction within 12 weeks prior to the first dose of NKX019
c. Any prior coronary artery bypass graft surgery
d. ≥ Class III New York Heart Association (NYHA) congestive heart failure (CHF), significantly decreased ejection fraction (EF ≤ 40%), or severe cardiac insufficiency
e. Prolongation of the QT interval corrected for heart rate (QTc) (Fridericia) interval of > 480 msec
f. 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

Active bleeding disorders

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 been treated with conization or loop electrosurgical excision procedure, and have had a normal repeat Papanicolaou test are allowed

Prior cellular therapy, including mesenchymal, CAR T or CAR NK cells or CD19 directed therapy


Please note that this is not an exhaustive list of inclusion and exclusion criteria and more may apply at screening.

Interested in joining this trial?