- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04678453
Safety of SNK01 in Subjects With Alzheimer's Disease (ASK-AD) (ASK-AD)
February 28, 2024 updated by: NKGen Biotech, Inc.
Single Center, Open Label, Phase 1 Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of SNK01 in Subjects With Alzheimer's Disease (AD)
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of SNK01 (autologous natural killer cell), as a single agent, for the treatment of subjects with Alzheimer's disease.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: NKGen Biotech, Inc.
- Phone Number: 949-396-6830
- Email: trials@nkgenbiotech.com
Study Locations
-
-
Baja California
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Tijuana, Baja California, Mexico, 22010
- Hospital Angeles Tijuana
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and protocol. If the subject is incapable of giving or signing informed consent, the subject must have a legally authorized representative willing to consent on their behalf.
- Subject must be ≥ 55 to 85 years old at the time of consent.
- Magnetic resonance imaging (MRI) scans of the brain within the past six months reveal evidence and findings consistent with Alzheimer's disease, including hippocampal volume loss and/or overall cerebral atrophy (cerebral volume loss).
- Fluorodeoxyglucose-positron emission tomography (FDG-PET) scans of the brain within the past six months reveal evidence and findings consistent with mild cognitive impairment or Alzheimer's disease.
- Subject presenting, during evaluation by the study Investigator, to have spontaneous memory loss or presenting abnormal memory function in early screening.
- Subject must be in good health with adequate hearing and vision.
- Subject must have a reliable caregiver.
- Women of childbearing potential who are not abstinent and intend to be sexually active with a nonsterilized male partner must be willing to use an adequate method of contraception throughout the study and for one month following the last day of the last administration of final study drug dose. Acceptable methods include hormonal contraception (oral contraceptives [taken 90 days prior to administration of study drug], intrauterine devices (IUD), or double barrier methods (e.g., vaginal diaphragm/vaginal sponge plus condoms, or condom plus spermicidal jelly), sexual abstinence, or a vasectomized partner.
Exclusion Criteria:
- Any medical or neurological conditions, other than Alzheimer's disease, that could contribute to the cause of cognitive impairment in the subject. Examples include, but are not limited to, frontotemporal dementia (FTD), Lewy body dementia, vascular dementia, Parkinson's disease, corticobasal degeneration, Creutzfeldt-Jakob disease, progressive supranuclear palsy, Huntington's disease, normal pressure hydrocephalus, seizure disorders or cerebral hypoxia, post-traumatic stress disorder (PTSD), or alcohol or medication use or abuse.
- Subject does not present with signs of mild cognitive impairment or Alzheimer's disease at screening, or during evaluation by the study Investigator.
- Subject presents with significant brain disease including hemorrhage or infarction.
- Subject has a history of cerebrovascular accident or transient ischemic attack (TIA), or unexplainable loss of consciousness during the past year.
- Subject has a history of schizophrenia, schizoaffective disorder, major depressive disorder (MDD), bipolar disorder, or any other clinically relevant psychiatric disease.
- Subject has a history of seizure episodes within the past three years.
- Subject has uncontrolled diabetes mellitus.
- Subject has a history of unstable angina, myocardial infarction, chronic heart failure, or clinically relevant conduction abnormalities within the year prior to screening.
- Subject suffers from renal or hepatic failure.
- Subject is infected with the human immunodeficiency virus (HIV), Hepatitis B (Hep B), Hepatitis C (Hep C), or any other infection or active systemic disease.
- Subject is using anticoagulants (except aspirin at or below a prophylactic dose).
- Subject is currently exceeding the normal recommended dosage for any drug used to treat Alzheimer's disease (e.g., memantine or acetylcholinesterase inhibitors [AChEI]).
- Subject has contraindication to MRI scans, FDG-PET scans, or lumbar spinal taps.
- Subject whose safety is considered to be at risk from trial's intervention, as determined by the study Investigator.
- Pregnant or lactating female subjects.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1 - Low dose SNK01
SNK01 (low dose) administered once every three weeks (Q3W) for four cycles.
|
Patient-specific ex vivo expanded autologous natural killer cells
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Experimental: Cohort 2 - Medium dose SNK01
SNK01 (medium dose) administered Q3W for four cycles.
|
Patient-specific ex vivo expanded autologous natural killer cells
|
Experimental: Cohort 3 - High dose SNK01
SNK01 (high dose) administered Q3W for four cycles.
|
Patient-specific ex vivo expanded autologous natural killer cells
|
Experimental: Cohort 4 - SNK01 at Maximum Tolerated Dose (MTD) / Recommended Phase 2 Dose (RP2D)
SNK01 (at MTD/RP2D) administered Q3W for four cycles.
|
Patient-specific ex vivo expanded autologous natural killer cells
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine the safety profile of SNK01 monotherapy in patients with mild cognitive impairment (MCI) or Alzheimer's Disease by monitoring for adverse events.
Time Frame: Up to 6 months
|
Evaluated by the number of treatment emergent adverse event (TEAE) Grade 3 or higher considered to be related to SNK01, adverse events (AEs) of Grade 3 or higher using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v5.0, measurements of vital signs, clinical laboratory tests and physical examination.
|
Up to 6 months
|
To determine the tolerability of SNK01 monotherapy in patients with mild cognitive impairment (MCI) or Alzheimer's Disease by monitoring for adverse events.
Time Frame: Up to 6 months
|
Evaluated by the number of treatment emergent adverse event (TEAE) Grade 3 or higher considered to be related to SNK01, adverse events (AEs) of Grade 3 or higher using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v5.0, measurements of vital signs, clinical laboratory tests and physical examination.
|
Up to 6 months
|
To determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of SNK01 monotherapy.
Time Frame: Up to 6 months
|
Assessed by the incidence of dose-limiting toxicities, defined by treatment emergent adverse event (TEAE) Grade 3 or higher considered to be related to SNK01, in each dose level.
|
Up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess preliminary efficacy of SNK01 measured by Alzheimer's Disease Assessment Scale Cognitive subscale (ADAS-Cog).
Time Frame: Baseline, Week 11, End of Study (Week 22)
|
Baseline, Week 11, End of Study (Week 22)
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To assess preliminary efficacy of SNK01 measured by Mini-Mental Status Exam (MMSE).
Time Frame: Baseline, Week 11, End of Study (Week 22)
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Baseline, Week 11, End of Study (Week 22)
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To assess preliminary efficacy of SNK01 measured by Clinical Dementia Rating Scale: Sum of Boxes (CDR-SB).
Time Frame: Baseline, Week 11, End of Study (Week 22)
|
Baseline, Week 11, End of Study (Week 22)
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To assess preliminary efficacy of SNK01 measured by Alzheimer's Disease Composite Score (ADCOMS).
Time Frame: Baseline, Week 11, End of Study (Week 22)
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Baseline, Week 11, End of Study (Week 22)
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To assess preliminary efficacy of SNK01 measured by cerebrospinal fluid (CSF) biomarkers: amyloid beta 42, T-tau and P-tau.
Time Frame: Baseline, Week 11, End of Study (Week 22)
|
Baseline, Week 11, End of Study (Week 22)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Clemente Humberto Zúñiga Gil, MD, Hospital Angeles Tijuana
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 6, 2021
Primary Completion (Actual)
August 16, 2023
Study Completion (Actual)
January 31, 2024
Study Registration Dates
First Submitted
December 9, 2020
First Submitted That Met QC Criteria
December 16, 2020
First Posted (Actual)
December 22, 2020
Study Record Updates
Last Update Posted (Estimated)
March 1, 2024
Last Update Submitted That Met QC Criteria
February 28, 2024
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNK01-MX04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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