Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Multiple Dosing Interval, 2-period Study of the Safety, Tolerability and Effectiveness of Adoptively Transferred Posoleuccel (ALVR105) Multivirus-specific T Cells in Kidney Transplant Recipients With Either High or Low Levels of BK Viremia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AlloVir
- 入组人数
- 61
- 试验地点
- 66
- 主要终点
- Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
研究概览
简要总结
The purpose of this study is to compare Posoleucel (formerly known as ALVR105; Viralym-M) to placebo in kidney transplant recipients who have high or low levels of BK virus in their blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients who had a kidney transplant performed greater than or equal to 28 days prior to enrollment
- •At least 1 identified, suitably matched Posoleucel (ALVR105) cell line for infusion is available.
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- •Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
排除标准
- •Undergone allogeneic hematopoietic cell transplantation
- •Evidence or history of graft versus host disease (GVHD) or cytokine release syndrome (CRS).
- •Uncontrolled or progressive bacterial or fungal infections
- •Known or presumed pneumonia
- •Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5 mg/kg/day or equivalent).
- •Pregnant or lactating or planning to become pregnant.
- •Weight <40 kg.
- •Patients who received, or planned to receive abatacept or belatacept, within 3 months of screening
结局指标
主要结局
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
时间窗: Day 1 to Week 24
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs are defined as AEs with a start date and time on or after the first dose of study treatment through the end of study. Clinically significant changes in vital signs, physical exams, laboratory assessments and electrocardiograms were also reported as TEAEs.
次要结局
- Change From Baseline in BK Viral Load(Baseline and Week 24)