A Phase 1/2 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With Autoimmune Disease
Nkarta, Inc.
Summary
This is an open-label, multi-center, non-randomized, Phase 1/2 study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with active lupus nephritis (LN) or primary membranous nephropathy (pMN).
Description
Dose escalation of NKX019 will utilize a "3+3" design to determine the recommended dose(s) for enrolling additional participants across indications. The study will evaluate safety and tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics 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 LD regimen of Cy alone.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
General Inclusion Criteria: 1. Age ≥18 and ≤70 2. Progression despite maximal tolerated doses of renin-angiotensin system (RAS) blockade agents 3. For participants taking chronic corticosteroids for management of the disease under study, 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 4. Negative SARS-CoV-2 test 5. For subjects on immunosuppressives or immunomodulators (other than corticosteroids), all doses must be stable for ≥ 4 weeks prior to Screening LN-specific Inclusion Criteria: 1. Score of 10 or…
Interventions
- DrugNKX019
NKX019 is an investigational allogeneic CD19-Directed CAR NK
- DrugFludarabine, Cyclophosphamide
For Lymphodepletion
Locations (16)
- Nkarta Investigational SiteLittle Rock, Arkansas
- Nkarta Investigational SiteGainesville, Florida
- Nkarta Investigational SiteMiami, Florida
- Nkarta Investigational SitePlantation, Florida
- Nkarta Investigational SiteTampa, Florida
- Nkarta Investigational SiteAtlanta, Georgia