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.
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
For participants taking corticosteroids, the prednisone (or equivalent) dose must be ≤20 mg/day at 2 weeks prior to Screening and stable for ≥ 14 days before start of Screening
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
Congenital or acquired immunodeficiency resulting in severe infection or those receiving chronic immunoglobulin replacement therapy
Single group
NKX019
DrugNKX019 is an investigational allogeneic CD19-Directed CAR NK
Fludarabine
DrugLymphodepletion
Cyclophosphamide
DrugLymphodepletion
Incidence of Dose-limiting toxicities (DLTs) [Safety and Tolerability]
Incidence of DLTs will be evaluated
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence and severity of treatment-emergent adverse events will be evaluated
For all participants with Interstitial Lung Disease (ILD)
Change from baseline in % predicted forced vital capacity (FVC) over time
For all participants with Interstitial Lung Disease (ILD)
Change from baseline % predicted CO (DLCO) corrected for hemoglobin \[and as appropriate alveolar volume (AV)\] over time
For all participants with Interstitial Lung Disease (ILD)
Time to improvement in FVC by ≥5% or ≥10%
For all participants with Interstitial Lung Disease (ILD)
Proportion of participants with improvement in FVC by ≥5% or ≥10%
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