Safety of SNK01 in Subjects With Alzheimer's Disease (ASK-AD) (ASK-AD)

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ClinicalTrials.gov Identifier: NCT04678453

Recruitment Status : Recruiting

First Posted : December 22, 2020

Last Update Posted : May 11, 2023

See Contacts and Locations

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

NKGen Biotech, Inc.

Tracking Information

First Submitted Date ^ICMJE

December 9, 2020

First Posted Date ^ICMJE

December 22, 2020

Last Update Posted Date

May 11, 2023

Actual Study Start Date ^ICMJE

January 6, 2021

Estimated Primary Completion Date

December 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.
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.
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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

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) ]
To assess preliminary efficacy of SNK01 measured by Mini-Mental Status Exam (MMSE). [ Time Frame: Baseline, Week 11, End of Study (Week 22) ]
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) ]
To assess preliminary efficacy of SNK01 measured by Alzheimer's Disease Composite Score (ADCOMS). [ Time Frame: Baseline, Week 11, End of Study (Week 22) ]
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) ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety of SNK01 in Subjects With Alzheimer's Disease (ASK-AD)

Official Title ^ICMJE

Single Center, Open Label, Phase 1 Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of SNK01 in Subjects With Alzheimer's Disease (AD)

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Alzheimer Disease
Neuro-Degenerative Disease

Intervention ^ICMJE

Biological: SNK01

Patient-specific ex vivo expanded autologous natural killer cells

Study Arms ^ICMJE

Experimental: Cohort 1 - Low dose SNK01
SNK01 (low dose) administered once every three weeks (Q3W) for four cycles.

Intervention: Biological: SNK01
Experimental: Cohort 2 - Medium dose SNK01
SNK01 (medium dose) administered Q3W for four cycles.

Intervention: Biological: SNK01
Experimental: Cohort 3 - High dose SNK01
SNK01 (high dose) administered Q3W for four cycles.

Intervention: Biological: SNK01
Experimental: Cohort 4 - SNK01 at Maximum Tolerated Dose (MTD) / Recommended Phase 2 Dose (RP2D)
SNK01 (at MTD/RP2D) administered Q3W for four cycles.

Intervention: Biological: SNK01

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Estimated Study Completion Date ^ICMJE

December 2023

Estimated Primary Completion Date

December 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

55 Years to 85 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: NKGen Biotech, Inc.

949-396-6830

trials@nkgenbiotech.com

Listed Location Countries ^ICMJE

Mexico

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT04678453

Other Study ID Numbers ^ICMJE

SNK01-MX04

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

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

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

NKGen Biotech, Inc.

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

NKGen Biotech, Inc.

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Clemente Humberto Zúñiga Gil, MD

Hospital Angeles Tijuana

PRS Account

NKGen Biotech, Inc.

Verification Date

March 2023

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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