Phase 1/2, Double-Blind, Placebo-Controlled, Dose Escalation and Expansion Study of ALVR106 in Addition to Standard of Care for the Treatment of High-Risk Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AlloVir
- 入组人数
- 17
- 试验地点
- 42
- 主要终点
- Change in Viral Load From Baseline to Day 28 (Part B)
研究概览
简要总结
A study to evaluate ALVR106; an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets four community acquired respiratory viruses: respiratory syncytial virus (RSV), influenza, human metapneumovirus (hMPV), and/or parainfluenza virus (PIV) following hematopoietic cell transplant (HCT) and solid organ transplant (SOT).
详细描述
The study hypothesis is that the administration of ALVR106, multi-virus specific T cells, plus standard of care, to post HCT or SOT patients suffering from infection with any of the four targeted viruses (RSV, influenza, hMPV, and/or PIV) will be safe and demonstrate shorter time to resolution of the respiratory viral infection (as measured by resolution of symptoms and viral load clearance in nasal swab) compared to patients treated with placebo.
This trial will consist of two parts: Part A is Dose Escalation and Part B is Cohort Expansion.
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
- 17 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergone hematopoietic cell transplantation (HCT) ≥21 days or solid organ transplantation (SOT) ≥28 days prior to study treatment administration
- •Detection of at least 1 target virus of interest (ie, RSV, influenza, hMPV, and/or PIV)
- •Diagnosis of Upper or mild Lower Respiratory Tract Infection
排除标准
- •Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 mg/kg/day)
- •Infection by novel coronavirus disease 2019 (COVID-19)
- •For HCT patients, evidence of Grade >2 GVHD; and for SOT patients, any history or evidence of GVHD
结局指标
主要结局
Change in Viral Load From Baseline to Day 28 (Part B)
时间窗: Baseline and Day 28 (Part B)
Change from Baseline in viral load as measured by quantitative PCR of nasal swab
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A)
时间窗: Day 1 up to 12 months
A TEAE was defined as an adverse event (AE) with a start date and time on or after the first dose of study treatment. A serious AE (SAE) was an AE that met at least one of the following serious criteria: fatal, life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other important medical event. TEAEs of special interest (AESI) included new/worsening graft versus host disease, graft failure or rejection, cytokine release syndrome, infusion related reactions, new/worsening pneumonitis, and progressive dyspnea. Treatment-related refers to the assessment of a relationship between study treatment and the event by the investigator.
次要结局
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part B)(Day 1 up to 12 months)
- Change in Viral Load Cycle Threshold From Baseline to Day 28 (Part A)(Baseline and Day 28)
- Identify the Recommended Phase 2 Dose (RP2D) (Part A)(Day 1 up to 12 months)
- Percentage Reduction in Viral Load From Baseline to Month 6 (Part B)(Day 1 and Month 6)