A Phase 1/2 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With Immune-Mediated Diseases
Nkarta, Inc.
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.
Description
Dose escalation of NKX019 will utilize a "3+3" design to determine the recommended dose(s) for expansion for enrolling additional participants across indications. The study will evaluate safety and tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity in participants with autoimmune diseases. Participants will receive a cycle consisting of lymphodepletion with fludarabine and cyclophosphamide (Flu/Cy) followed by three doses of NKX019. Participants who are cytopenic may receive a modified lymphodepletion regimen of Cy alone.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥18 and ≤70 2. 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 3. For subjects on immunosuppressives or immunomodulators (other than corticosteroids), all doses must be stable for ≥ 4 weeks prior to Screening SSc: 1. Meets the 2013 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria for SSc 2. Meet criteria a and/or b: 1. Severe skin involvement defined as mRSS ≥ 3…
Interventions
- DrugNKX019
NKX019 is an investigational allogeneic CD19-Directed CAR NK
- DrugFludarabine
Lymphodepletion
- DrugCyclophosphamide
Lymphodepletion
Locations (15)
- Nkarta Investigational SiteOrange, California
- Nkarta Investigational SiteMiami, Florida
- Nkarta Investigational SitePlantation, Florida
- Nkarta Investigational SiteChicago, Illinois
- Nkarta Investigational SiteFairway, Kansas
- Nkarta Investigational SiteAnn Arbor, Michigan