Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AlloVir
- 入组人数
- 26
- 试验地点
- 16
- 主要终点
- Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease
研究概览
简要总结
This is a Phase 2 study to evaluate posoleucel (ALVR105, formerly Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.
详细描述
This is a Phase 2/3, multicenter, randomized, double-blind, placebo controlled trial comparing posoleucel to placebo for the prevention of infection or disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV in high-risk adult and pediatric patients after allogeneic HCT.
There are 2 parts to the study, an open label Phase 2 cohort described in this posting, and a randomized, placebo controlled Phase 3 cohort described in NCT05305040. In the Phase 2 part, 25 to 35 eligible allogeneic HCT recipients will be enrolled and will receive 7 doses of posoleucel over 12 weeks, followed by a 14 week follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥1 year of age at the day of screening visit.
- •Either no evidence of viral infection or viremia, or asymptomatic, viral infection with 3 or fewer viruses of interest at time of screening
- •Within 15 and 42 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment
- •Meet one or more of the following criteria at the time of randomization:
- •Related (sibling) donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B or -DR
- •Haploidentical donor
- •Unrelated donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B, -C, or -DR
- •Use of umbilical cord blood as stem cell source
- •Ex vivo graft manipulation resulting in T cell depletion
- •Lymphocyte Count <180/mm3 and/or cluster of differentiation 4 (CD4) Count <50/mm3
排除标准
- •History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 months prior to randomization
- •Evidence of active Grade >2 acute GVHD
- •Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections
- •Known history or current (suspected) diagnosis of CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies
- •Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 mg/kg/day) within 24 hours prior to dosing
- •Relapse of primary malignancy other than minimal residual disease
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion
干预措施: Posoleucel (ALVR105) (Biological)
结局指标
主要结局
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease
时间窗: Through Week 14
The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV through Week 14
次要结局
- Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Epstein-Barr Virus (EBV)(through Week 26)
- Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Adenovirus (AdV)(Through Week 26)
- Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Cytomegalovirus (CMV)(Through Week 26)
- Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Human Herpes Virus 6 (HHV-6)(Through Week 26)
- Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to BKV(Through Week 26)
- Rates of Overall and Non-Relapse Mortality(Through Week 52)
- Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease(Through Week 26)
- Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to John Cunningham Virus (JCV)(Through Week 26)