A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2) (NCT06733935) | Clinical Trial Compass
RecruitingPhase 1/2
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
United States144 participantsStarted 2024-11-04
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age ≥18 and ≤70
✓. For participants taking corticosteroids, the prednisone (or equivalent) dose must be ≤40 mg/day at 6 weeks prior to Screening and stable for ≥ 14 days before start of Screening
✓. For subjects on immunosuppressives or immunomodulators (other than corticosteroids), all doses must be stable for ≥ 4 weeks prior to Screening
✓. Meets the 2013 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria for SSc
✓. Meet criteria a and/or b:
✓. Severe skin involvement defined as mRSS ≥ 30 or active skin disease defined as mRSS ≥ 15 at screening and one or more of the following within the prior 6 months of screening:
✓. Moderate to severe Interstitial Lung Disease (ILD) defined by evidence of ILD on High-resolution computed tomography (HRCT) and FVC \< 70% of predicted or DLCO (hemoglobin or alveolar volume corrected) \< 70% of predicted or ILD on HRCT and progressive ILD meeting at least 2 of the following 3 criteria within the prior 6 months of screening:
✓. Presence of anti-nuclear antibody ≥ 2 x upper limit of normal (ULN)
Exclusion criteria
✕. eGFR \< 45 ml/min/1.73m2
✕. 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
What they're measuring
1
Incidence of Dose-limiting toxicities (DLTs) [Safety and Tolerability]
Timeframe: The first 28 days after the first NKX019 dose
2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: From the first administration of NKX019 until the last administration of any study treatment + 30 days
✕. Congenital or acquired immunodeficiency resulting in severe infection or those receiving chronic immunoglobulin replacement therapy
✕. Liver disease or dysfunction, including cirrhosis and/or bilirubin ≥ 3 times the upper limit of normal
✕. Pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral steroids, resting hypoxemia (\<92% oxygen saturation via pulse oximetry) on room air, or significant smoking history (i.e. \>10 pack/year) with active pulmonary disease