A Phase I, Single-Center, Open-Label, Dose-Escalation Clinical Trial to Assess the Safety and Tolerability of an Intranasal Memory T Lymphocytes Solution in Adult Females: vRELEASE I. (vRELEASE I)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Safety and tolerability
研究概览
简要总结
Proof-of-concept trial to assess the safety and tolerability of intranasal administration of a male donor memory T lymphocyte solution in females aged between 18 - 55 years of age.
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
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects between 18 - 55 years of age.
- •Participants are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- •Patients with the ability to comprehend and sign the informed consent.
- •Written informed consent obtained prior to any screening procedures.
- •Subjects in good health with no baseline disease of any kind.
排除标准
- •Participants are not willing or able to comply with either: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
- •Participants who are currently under medical follow-up for any medical condition or who are regularly taking medication for any condition.
- •Subject has experienced symptoms consistent with a respiratory infection within the 7 days prior to the administration of the investigational treatment.
- •Have a known history of human immunodeficiency virus infection, Hepatitis B or Hepatitis C; testing is not required in the absence of prior documentation or known history.
- •Have a known history of drug substance abuse.
- •Pregnant or breastfeeding women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
- •Any other condition that, in the opinion if the Investigator, may interfere with the efficacy and/or safety evaluation of the trial.
- •Any condition or situation precluding or interfering with the compliance with the protocol.
- •Participant is currently enrolled or has enrolled in a clinical trial three months prior to inclusion in the current study.
研究组 & 干预措施
Intervention arm Group 1
Administration of a total of 3x106 cells administered over three 1x106cell doses.
干预措施: CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors. (Other)
Intervention arm Group 2
Administration of a total of 15x106 cells administered over three 5x106cell doses.
干预措施: CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors. (Other)
Intervention arm Group 3
Administration of a total of cumulative 30x106 cells administered over three 10x106cell doses.
干预措施: CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors. (Other)
结局指标
主要结局
Safety and tolerability
时间窗: 6 months
Safety and tolerability will be evaluated based on the frequency and attribute of DLT (dose limiting toxicities) in the first 7 days after solution administration and the incidence of all AEs and serious adverse events (SAEs) during study period. The primary endpoint will be DLT, defined as any grade 3 or higher adverse event (as defined in the Common Terminology Criteria for Adverse Events (CTCAE) version 5) with an attribution of definitely or probably related to the product administration. The highest dose found safe in the present study will be determined as the maximum tolerated dose (MTD).
次要结局
- Persistence of donor cells in the nasal mucosa of participants post-administration of treatment cells(6 months)
研究者
Cristina Calvo Rey
Head Clinician. Pediatric and Infectious Diseases Department
Hospital Universitario La Paz