CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 36 target
Drug / intervention
SNK01 +1 morebiological
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Diagnosis of Alzheimer's dementia per 2011 NIA-AA diagnostic guidelines
  • ✓Age 40-85 years
  • ✓Positive amyloid PET evidence within past 6 months
  • ✓CDR-SB score 9.5 to <16.0
Key exclusion· 23
  • ✕Substantial cerebrovascular disease (Fazekas Grade 3)
  • ✕Stroke or intracranial hemorrhage temporally related to cognitive impairment onset
  • ✕Substance use disorder not in remission ≥12 months
  • ✕Cancer history or treatment within last 5 years (except basal cell carcinoma)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT06189963Phase 2RecruitingOn Track
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A Phase I/IIa, Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of SNK01 in Participants With Moderate Alzheimer's Disease

NKGen Biotech, Inc.·interventional·Posted Jan 5, 2024·Updated May 14, 2026

In Brief

A Phase 2 clinical trial evaluating SNK01 and Placebo for Moderate Alzheimer Disease. Currently recruiting, targeting 36 participants across 8 sites in 2 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsModerate Alzheimer Disease
CountriesCanada, United States
Collaborators--

Timeline

Phase 2Recruiting
2024202520262027
First PostedJan 5, 2024
Enrollment StartNov 21, 2023
Primary CompletionDec 1, 2026
Study CompletionJun 1, 2027
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 2.5 years agoPrimary completion in 5 months

Interventions

SNK01biological

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

Placeboother

Sodium Lactate Hartmann's Solution