NCT07777484招募中1 期
An Unblinded, Single Arm, Pilot Observational Study to Test the Safety, Tolerability, Immunogenicity and the Biological Effects of TRB-001 Vaccination in Individuals Who Have Previously Undergone aSyn Immunotherapy
Tridem Bioscience FlexCo1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2026年7月28日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
An unblinded, single arm, pilot observational study to test the safety, tolerability, immunogenicity and the biological effects of TRB-001 vaccination in individuals who have previously undergone aSyn immunotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18-years of age
- •Female or male with previous treatment with active aSyn immunotherapy
- •Parkinson's disease diagnosis (any stage)
- •Understands and agrees to comply with the study procedures and provides written informed consent
排除标准
- •Women of childbearing potential without use of contraception
- •Women who are pregnant or lactating
- •Contraindication for MRI or lumbar puncture
- •Known or suspected allergy, or history of anaphylaxis, to vaccines or their excipients, if considered relevant by the investigator
- •Presence or history of autoimmune disease or immunodeficiency, if considered relevant by the investigator
- •Presence of active infectious disease (hepatitis B, hepatitis C, or human immunodeficiency virus (HIV))
- •Significant cognitive impairment or clinical dementia, or a Montreal Cognitive Assessment (MoCA) score <26
- •High suspicion of other parkinsonian syndromes, such as multiple system atrophy, progressive supranuclear palsy, drug-induced Parkinsonism and post-encephalitic Parkinsonism
- •Any relevant systemic illness. This includes cardiovascular, hepatic, gastroenterological, respiratory, endocrinological, hematologic disease, or any other condition that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study, unless patient has been on stable doses of medication for any of these concurrent illnesses for at least 3 months prior to study entry
- •Unstable psychiatric illness, including psychosis, suicidal ideation, untreated major depression, schizophrenia, or bipolar affective disorder within 90 days before Visit 1, as determined by the investigator
- •History of drug or alcohol abuse within the past 5 years
- •Recent history (≤2 years) of cancer (exceptions; basal cell carcinoma, intraepithelial cervical neoplasia)
- •Birthmarks, tattoos, wounds, or skin conditions that may obscure the assessment of injection site reactions
- •Participation in the active treatment phase of any non-PD clinical trial within 30 days prior to Visit 1
- •Dose limiting toxicity to previous immunization with aSyn-based PD vaccine
- •Current immunosuppressive therapy
- •Employee at the study site, spouse/partner or relative of any study staff (e.g. investigator, sub-investigators, or study nurse) or relationship to sponsor
研究组 & 干预措施
Verum Arm
Experimental
Each participant will receive 1 immunization with Vaccine at week 0. Participants may also receive a 2nd immunization at week 4-6, pending safety and immunogenicity results and decision from PI, Sponsor, and Medical Monitor.
干预措施: TRB-001 (Biological)
结局指标
主要结局
Safety and Tolerability
时间窗: 6 months
Incidence of local and systemic treatment-emergent adverse events (TEAEs) (occurrence, intensity, duration, and relationship to IMP) over 6-months
Incidence of local and systemic treatment-emergent adverse events (TEAEs)
时间窗: 6 months
Incidence of local and systemic treatment-emergent adverse events (TEAEs) (occurrence, intensity, duration, and relationship to IMP) over 6-months
次要结局
- Efficacy Endpoints(6 months)
- Efficany Endpoints(6 months)
- Safety Endpoints(12 months)
- Efficacy Endpoints(12 months)
- Titers of vaccine-induced antibodies in blood and CSF(6 months)
- Change from baseline in total aSyn levels(6 months)
- Change in levels of aggregated aSyn in blood and CSF(6 months)
- Change in GFAP and Neurofilament light chain in CSF(6 months)
- Avidity of antibodies induced for aggregated aSyn(6 months)
- Selectivity of antibodies induced by TRB-001(6 months)
- Change from baseline of the seed amplification assay signal (CSF)(6 months)
- Correlation between measures of the antibody response(6 months)
- Change in MDS-UPDRS I, II, III, and IV(6 months)
- Change from baseline in PD symptoms(6 months)
- Change in symptomatic PD medication(6 months)
- Change in levels of circulating extracellular vesicle (EV)-based biomarkers(6 months)
- Change in the number of vaccine specific B- and T cell clones(6 months)
- Incidence of local and systemic TEAEs(12 months)
- Change from baseline in total aSyn levels(12 months)
- Change from baseline in levels of aggregated aSyn in blood(12 months)
- Titers of vaccine-induced antibodies in blood(12 months)
- Change from baseline in MDS-UPDRS I, II, III, IV at 12 month time period(12 months)
- Change from baseline in PD symptoms at 12 month time period(12 months)
- Change from baseline in symptomatic PD medication at 12 month time period(12 months)
研究者
研究点 (1)
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