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

NCT ID: NCT04678453

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-06
• Study Completion Date: 2024-01-31

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.

Conditions

Alzheimer Disease; Neuro-Degenerative Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1 - Low dose SNK01

SNK01 (low dose) administered once every three weeks (Q3W) for four cycles.

Group Type: EXPERIMENTAL

SNK01

Intervention Type: BIOLOGICAL

Patient-specific ex vivo expanded autologous natural killer cells

Cohort 2 - Medium dose SNK01

SNK01 (medium dose) administered Q3W for four cycles.

Group Type: EXPERIMENTAL

SNK01

Intervention Type: BIOLOGICAL

Patient-specific ex vivo expanded autologous natural killer cells

Cohort 3 - High dose SNK01

SNK01 (high dose) administered Q3W for four cycles.

Group Type: EXPERIMENTAL

SNK01

Intervention Type: BIOLOGICAL

Patient-specific ex vivo expanded autologous natural killer cells

Cohort 4 - SNK01 at Maximum Tolerated Dose (MTD) / Recommended Phase 2 Dose (RP2D)

SNK01 (at MTD/RP2D) administered Q3W for four cycles.

Group Type: EXPERIMENTAL

SNK01

Intervention Type: BIOLOGICAL

Patient-specific ex vivo expanded autologous natural killer cells

Interventions

SNK01

Patient-specific ex vivo expanded autologous natural killer cells

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NKGen Biotech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clemente Humberto Zúñiga Gil, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Angeles Tijuana

Locations

Hospital Angeles Tijuana

Tijuana, Estado de Baja California, Mexico

Countries

Mexico

References

Zuniga CH, Acosta BI, Menchaca R, Amescua CA, Hong S, Hui L, Gil M, Rhee YH, Yoon S, Kim M, Chang PY, Kim YM, Song PY, Betito K. Treatment of Alzheimer's Disease subjects with expanded non-genetically modified autologous natural killer cells (SNK01): a phase I study. Alzheimers Res Ther. 2025 Feb 12;17(1):40. doi: 10.1186/s13195-025-01681-2.

Reference Type: DERIVED

PMID: 39939891 (View on PubMed)

Other Identifiers

SNK01-MX04

Identifier Type: -

Identifier Source: org_study_id