NCT06189963

Clinical Study of SNK01 in Participants With Moderate Alzheimer's Disease

A Phase I/IIa, Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of SNK01 in Participants With Moderate Alzheimer's Disease

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: NKGen Biotech, Inc. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test SNK01 in participants with moderate Alzheimer's Disease. The main questions it aims to answer are: 1. Is SNK01 safe and tolerable when administered every 3 weeks for up to 1 year as an intravenous infusion 2. Can SNK01 administration improve cognitive assessment scores and biomarkers

Conditions

• Moderate Alzheimer Disease

Interventions

Type	Name	Description
BIOLOGICAL	SNK01	SNK01 is a novel cell-based, patient specific ex vivo expanded autologous natural killer (NK) cell, immunotherapeutic drug
OTHER	Placebo	Sodium Lactate Hartmann's Solution

Timeline

• Start date: 2023-11-21
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2024-01-05
• Last updated: 2025-11-10

Locations

5 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study