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Drug Development.

Paul Y Song1, Lucia Hui1, Katia Betito1

  • 1NKGen Biotech, Santa Ana, CA, USA.

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|December 25, 2025
PubMed
Summary
This summary is machine-generated.

Troculeucel, a novel Natural Killer (NK) cell therapy, shows promise in Alzheimer's disease (AD) by clearing toxic proteins and reducing neuroinflammation. Phase I trials indicate safety and potential cognitive benefits in patients with AD.

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Area of Science:

  • Neuroscience
  • Immunology
  • Cell Therapy

Background:

  • Alzheimer's disease (AD) involves neuroinflammation driven by misfolded proteins and autoreactive T cells.
  • Natural Killer (NK) cells offer potential therapeutic benefits by clearing protein deposits and eliminating harmful T cells.
  • Troculeucel is an innovative, non-genetically modified autologous NK cell product designed for enhanced cytotoxicity and activating receptor expression.

Purpose of the Study:

  • To evaluate Troculeucel's in vitro efficacy against amyloid and alpha-synuclein proteins and autoreactive T cells.
  • To assess the safety and preliminary efficacy of Troculeucel in patients with Alzheimer's disease through Phase I clinical trials.
  • To characterize Troculeucel's expression of key receptors (CXCR3, DNAM-1, NKG2D) involved in targeting pathological cells.

Main Methods:

  • In vitro assays to assess Troculeucel's phagocytic and cytotoxic capabilities against disease-related proteins and T cells.
  • Two Phase I clinical trials (NCT04678453, NCT06189963) administering Troculeucel to Alzheimer's disease patients.
  • Monitoring of safety, cognitive function (ADCOMS scores), and cerebrospinal fluid (CSF) biomarkers (Aβ42/40, p-tau, alpha-synuclein, GFAP).

Main Results:

  • In vitro, Troculeucel effectively phagocytosed and digested amyloid and alpha-synuclein proteins.
  • Troculeucel demonstrated high expression of DNAM-1 (99%) and NKG2D, activating only in the presence of autoreactive T cells.
  • Phase I trials showed 92.3% of patients had stable or improved cognitive scores, with Troculeucel crossing the blood-brain barrier (BBB) and improving key CSF biomarkers.
  • Significant reduction in GFAP levels was observed, particularly at higher doses, correlating with cognitive improvements.

Conclusions:

  • Troculeucel, derived from AD patients, effectively crosses the BBB and targets autoreactive T cells to mitigate neuroinflammation.
  • The therapy improves CSF levels of amyloid and alpha-synuclein, suggesting a mechanism for reducing protein aggregates.
  • Observed reductions in GFAP correlate with stabilized or improved cognitive function, highlighting Troculeucel's therapeutic potential in Alzheimer's disease.