RecruitingPhase 1Phase 2NCT06189963

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


Sponsor

NKGen Biotech, Inc.

Enrollment

36 participants

Start Date

Nov 21, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing SNK01, an experimental immune cell therapy, to see if it can slow the progression of moderate Alzheimer's disease. **You may be eligible if...** - You are between 40 and 85 years old - You have been diagnosed with Alzheimer's disease (moderate stage) - A brain scan in the last 6 months confirmed Alzheimer's-related protein buildup - You have a reliable caregiver or family member who can attend study visits with you - You have at least 6 years of formal education **You may NOT be eligible if...** - You have had a stroke or significant brain blood vessel disease - You have an active cancer diagnosis (other than a minor skin cancer) within the last 5 years - You have uncontrolled heart disease, liver disease, or diabetes - You have a history of seizures in the past 3 years - You have HIV, hepatitis B, or hepatitis C - You have had suicidal thoughts or a suicide attempt in the past 2 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSNK01

SNK01 is a novel cell-based, patient specific ex vivo expanded autologous natural killer (NK) cell, immunotherapeutic drug

OTHERPlacebo

Sodium Lactate Hartmann's Solution


Locations(8)

Behavioral Research Specialists, LLC

Glendale, California, United States

Syrentis Clinical Research

Santa Ana, California, United States

Valiance Clinical Research

Tarzana, California, United States

K2 Medical Research

Maitland, Florida, United States

AdventHealth Research Institute

Orlando, Florida, United States

Rutgers Health

Newark, New Jersey, United States

Alzheimer's Disease Research Center

Albany, New York, United States

Ottawa Memory Clinic

Ottawa, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06189963