NKGen Biotech announced updated Phase 1 clinical trial data for troculeucel, an NK cell therapy for moderate Alzheimer’s disease. The data, presented at the AD/PD™ 2025 conference, showed promising cognitive improvements in patients receiving the highest dose of the therapy. The trial focused on safety and preliminary efficacy in moderate AD patients.
This development is potentially groundbreaking for Alzheimer’s treatment. Current treatments primarily focus on managing symptoms, while troculeucel appears to demonstrate disease-modifying potential. The observed cognitive improvements, coupled with positive changes in key biomarkers like GFAP and Aβ 42/40 ratio, suggest that troculeucel could offer a new avenue for addressing the underlying disease mechanisms. This is particularly crucial given the increasing prevalence of Alzheimer’s and the limited effectiveness of current therapies in slowing or reversing cognitive decline.
Three patients with moderate AD received 6 billion cells per treatment every three weeks. Two patients completed 17 doses and showed improvement from moderate to mild AD within three months. One patient maintained the improvement, while the other demonstrated continued improvement. Notably, no drug-related adverse reactions were observed. Biomarker data further supported the cognitive findings, with decreases in GFAP and improvements in Aβ 42/40 ratios observed in patients.
These positive Phase 1 results pave the way for a randomized, placebo-controlled Phase 2a trial. This next phase will be critical for validating the initial findings in a larger patient population and definitively establishing troculeucel’s efficacy. If the Phase 2a trial confirms these promising trends, troculeucel could represent a significant advancement in Alzheimer’s treatment, potentially offering a new therapeutic approach to modify disease progression and improve patient outcomes.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
