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Safety of SNK01 in Subjects With Mild Cognitive Impairment (MCI) and Alzheimer's Disease (ASK-AD)

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ClinicalTrials.gov Identifier: NCT04678453
Recruitment Status : Recruiting
First Posted : December 22, 2020
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
NKMax America, Inc.

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 mild cognitive impairment (MCI) or Alzheimer's disease.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Mild Cognitive Impairment Neuro-Degenerative Disease Biological: SNK01 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Center, Open Label, Phase 1 Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of SNK01 in Subjects With Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD)
Actual Study Start Date : January 6, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1 - Low dose SNK01
SNK01 (low dose) administered once every three weeks (Q3W) for four cycles.
Biological: SNK01
Patient-specific ex vivo expanded autologous natural killer cells

Experimental: Cohort 2 - Medium dose SNK01
SNK01 (medium dose) administered Q3W for four cycles.
Biological: SNK01
Patient-specific ex vivo expanded autologous natural killer cells

Experimental: Cohort 3 - High dose SNK01
SNK01 (high dose) administered Q3W for four cycles.
Biological: SNK01
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.
Biological: SNK01
Patient-specific ex vivo expanded autologous natural killer cells




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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) ]
  2. To assess preliminary efficacy of SNK01 measured by Mini-Mental Status Exam (MMSE). [ Time Frame: Baseline, Week 11, End of Study (Week 22) ]
  3. 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) ]
  4. To assess preliminary efficacy of SNK01 measured by Alzheimer's Disease Composite Score (ADCOMS). [ Time Frame: Baseline, Week 11, End of Study (Week 22) ]
  5. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04678453


Contacts
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Contact: NKMax America, Inc. 949-396-6830 trials@nkmaxamerica.com

Locations
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Mexico
Hospital Angeles Tijuana Recruiting
Tijuana, Baja California, Mexico, 22010
Contact: Clemente Humberto Zúñiga Gil, MD         
Sponsors and Collaborators
NKMax America, Inc.
Investigators
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Principal Investigator: Clemente Humberto Zúñiga Gil, MD Hospital Angeles Tijuana
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Responsible Party: NKMax America, Inc.
ClinicalTrials.gov Identifier: NCT04678453    
Other Study ID Numbers: SNK01-MX04
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021

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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
Keywords provided by NKMax America, Inc.:
Natural killer cell
NK cell
Expanded natural killer cell
Alzheimer's Disease
Mild Cognitive Impairment
Neurodegenerative diseases
Neurocognitive disorders
Brain diseases
Autologous natural killer cell
Additional relevant MeSH terms:
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Alzheimer Disease
Neurodegenerative Diseases
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurocognitive Disorders
Mental Disorders
Cognition Disorders