NCT04678453终止1 期
Single Center, Open Label, Phase 1 Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of SNK01 in Subjects With Alzheimer's Disease (AD)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- To determine the tolerability of SNK01 monotherapy in patients with mild cognitive impairment (MCI) or Alzheimer's Disease by monitoring for adverse events.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To determine the tolerability of SNK01 monotherapy in patients with mild cognitive impairment (MCI) or Alzheimer's Disease by monitoring for adverse events.
时间窗: 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.
时间窗: 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.
To determine the safety profile of SNK01 monotherapy in patients with mild cognitive impairment (MCI) or Alzheimer's Disease by monitoring for adverse events.
时间窗: 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.
次要结局
- To assess preliminary efficacy of SNK01 measured by Alzheimer's Disease Composite Score (ADCOMS).(Baseline, Week 11, End of Study (Week 22))
- To assess preliminary efficacy of SNK01 measured by Alzheimer's Disease Assessment Scale Cognitive subscale (ADAS-Cog).(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).(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.(Baseline, Week 11, End of Study (Week 22))
- To assess preliminary efficacy of SNK01 measured by Mini-Mental Status Exam (MMSE).(Baseline, Week 11, End of Study (Week 22))
研究者
研究点 (2)
Loading locations...
相似试验
撤回
1 期
Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR CancersAdvanced Solid TumorMetastatic CancerHER2-positive Breast CancerHER2-positive Gastric CancerHER-2 Protein OverexpressionOvarian CancerEsophageal CancerEndometrium CancerNon Small Cell Lung CancerEGF-R Positive Non-Small Cell Lung CancerHead and Neck Squamous Cell CarcinomaTriple Negative Breast CancerColorectal CancerPancreatic CancerCervical CancerBladder CancerSarcomaNCT04464967NKGen Biotech, Inc.
已完成
1 期
Study to Assess the Pharmacokinetics, Safety and Tolerability of Aztreonam-Avibactam in Healthy Chinese Participants.HealthyNCT04973826Pfizer12
招募中
1 期
CD70-targeted CAR-NKT Cells(CGC729) Therapy in the Renal Cell CarcinomaRenal Cell CarcinomaNCT06182735Fudan University9
已完成
1 期
A Study of DKN-01 in Multiple Myeloma or Advanced Solid TumorsMultiple MyelomaSolid TumorsNon-Small Cell Lung CancerNCT01457417Leap Therapeutics, Inc.32
已完成
1 期
Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on HaemodialysisEnd Stage Renal Disease on HemodialysisNCT05885763Vifor Fresenius Medical Care Renal Pharma30
相关资讯
NKGen Biotech's Troculeucel Shows Dose-Dependent Cognitive Benefits in Phase 1 Alzheimer's Disease Trials- NKGen Biotech reported encouraging Phase 1 results for troculeucel, an autologous NK cell therapy, showing 100% of moderate Alzheimer's disease patients achieved cognitive stability or improvement at three-month assessment.
- Higher cell doses (4-6 billion cells) demonstrated greater directional cognitive improvement and more frequent achievement of clinically meaningful change thresholds across standardized measures.
- Plasma GFAP emerged as a potential non-invasive biomarker, showing strong correlations with cognitive status that strengthened in patients receiving higher troculeucel doses.
- The therapy maintained a favorable safety profile with no treatment-related adverse events reported across both Phase 1 studies.6 months agoAlzheimer's Disease: Cell and Gene Therapy Advances in 2024- Lexeo Therapeutics' LX1001 gene therapy shows dose-dependent APOE2 expression increase and reduced tau biomarkers in APOE4 homozygote Alzheimer's patients.
- Lomecel-B cell therapy demonstrates safety and potential cognitive benefits in mild Alzheimer's patients, according to Phase 2a CLEAR MIND trial data.
- NKGen Biotech advances SNK01 natural killer cell therapy to Phase 2 after promising Phase 1 results, including cognitive function improvements.
- Regeneration Biomedical doses first patient in Phase 1 trial of RB-ADSC, an autologous stem cell therapy for Alzheimer's, showing no adverse events.last yearCell and Gene Therapies Emerge as Promising Avenues for Alzheimer's Disease Treatment• Several cell and gene therapies are under investigation for Alzheimer's disease, with some showing early signs of efficacy in clinical trials.
• NKGen's SNK01, an autologous NK cell therapy, demonstrated encouraging clinical activity and tolerability in a Phase 1 trial, with improvements in ADCOMS scores and CSF α-syn levels.
• Longeveron's Lomecel-B, an allogeneic MSC therapy, showed statistically significant improvements in ADCS-ADL scores and trends of improvement on MMSE in a Phase 2 trial.
• Beyond amyloid-targeting antibodies, researchers are exploring diverse targets like tau, inflammation, and viral proteins, with drug repurposing strategies also gaining traction.last year