NEW YORK – NKGen Biotech announced Thursday that it has dosed the first patient in the Phase II portion of a Phase I/IIa clinical trial testing the activity of its autologous natural killer cell therapy troculeucel in moderate Alzheimer's disease.
According to NKGen Biotech, three months after two of the three patients received troculeucel in the Phase I portion of the trial, they went from having moderate Alzheimer's symptoms to mild symptoms, based on the Clinical Dementia Rating-Sum of Boxes scale. None of the patients who were dosed with 6 billion natural killer cells experienced drug-related adverse reactions, the company said.
In the Phase II portion of the ongoing trial, Santa Ana, California-based NKGen Biotech is evaluating the efficacy and safety of troculeucel, previously known as SNK01, compared to placebo in 30 patients with moderate Alzheimer's disease. Twenty patients will be randomly enrolled in the treatment arm and 10 in the placebo arm. Investigators will also examine changes in cerebrospinal fluid biomarkers, including p-tau 181, Aβ42/40, glial fibrillary acidic protein, and neurofilament light chain.
In a previous open-label, dose-escalation proof-of-concept Phase I study, investigators reported that troculeucel also reduced levels of various biomarkers.
NKGen Biotech plans to report six-month interim cognitive data from the current Phase I cohort on troculeucel at an Alzheimer's disease conference in Q4 2024.