Enrollment is now open for the Ntrust-2 clinical trial, designed to evaluate the safety and efficacy of NKX019, an experimental cell therapy, in patients with ANCA-associated vasculitis (AAV) and other autoimmune disorders. This Phase 1 study will assess dose-escalating doses of NKX019 to determine its potential to induce long-term disease remission.
The trial aims to recruit up to 12 individuals diagnosed with AAV, systemic sclerosis, or idiopathic inflammatory myopathy. The study, cleared by the U.S. Food and Drug Administration (FDA) earlier this year, will be conducted across multiple centers, with specific locations to be announced. Ntrust-2 is Nkarta's second clinical trial investigating NKX019 in autoimmune diseases, following Ntrust-1, which is currently enrolling patients with lupus nephritis.
NKX019: Targeting B-Cells in Autoimmune Diseases
NKX019 is designed to eliminate B-cells, the immune cells responsible for producing harmful self-reactive antibodies that drive autoimmune responses in diseases like AAV. The therapy utilizes modified natural killer (NK) cells engineered to recognize CD19, a protein highly expressed on the surface of B-cells. These modified NK cells also carry IL-15, a signaling molecule intended to enhance their survival and activity.
To produce NKX019, NK cells are collected from healthy donors, genetically engineered, expanded, and cryopreserved, creating an off-the-shelf supply. Once thawed, NKX019 is infused into the patient's bloodstream, where it is expected to selectively destroy B-cells, thereby alleviating symptoms of AAV and other B-cell-mediated autoimmune conditions.
Trial Design and Treatment Protocol
In the Ntrust-2 trial, participants with AAV, systemic sclerosis, or idiopathic inflammatory myopathy will be enrolled into parallel treatment groups. Prior to NKX019 infusion, patients will receive cyclophosphamide, a chemotherapy agent, to deplete existing B-cells and other immune cells. NKX019 will then be administered at doses of 1 billion or 1.5 billion cells per dose on days 0, 3, and 7. Nkarta is evaluating the efficacy of NKX019 as a standalone therapy, without additional immunotherapies, to potentially expedite regulatory approval.
Paul J. Hastings, CEO of Nkarta, stated that the expansion of NKX019's clinical development to include AAV, systemic sclerosis, and idiopathic inflammatory myopathy, alongside ongoing trials in lupus nephritis and systemic lupus erythematosus, underscores the potential of NKX019 as a safe and accessible treatment option for individuals with autoimmune diseases. Preliminary results from Ntrust-1 and Ntrust-2 are expected next year.
