A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)
Trial Parameters
Brief 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).
Eligibility Criteria
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 more points on the American College of Rheumatology (ACR) 2019 classification criteria for SLE 2. Active biopsy proven lupus nephritis Class III or Class IV with or without Class V using the 2018 International Society of Nephrology and Renal Pathology Society (ISN/RPS) criteria (Bajema 2018) as evidenced on kidney biopsy during screening or within 6 months before screening. For subjects with primari