Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 Posoleucel (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
- 终止
- 发起方
- AlloVir
- 入组人数
- 451
- 试验地点
- 141
- 主要终点
- Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 14
研究概览
简要总结
This is a Phase 3 study to evaluate posoleucel (ALVR105, 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, a Phase 3 randomized study cohort described in this posting, and an open label Phase 2 cohort described in NCT04693637, which has completed enrollment. In this Phase 3 part, approximately 302 eligible allogeneic HCT recipients will be enrolled and will receive 7 doses of posoleucel or placebo over 12 weeks, followed by a 12 week follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any age at the day of screening visit.
- •No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6, and/or JCV
- •Within 25 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment at time of dosing
- •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
- •Matched or Mismatched unrelated donor
- •Use of umbilical cord blood as stem cell source
- •Ex vivo graft manipulation resulting in T cell depletion
- •Received anti-thymocyte globulin or alemtuzumab (Campath-1H)
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 Grade ≥3 CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies
- •Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >1.0 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.
结局指标
主要结局
Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 14
时间窗: Through Week 14
The average number of clinically significant infections or episodes of end-organ disease per participant due to Adenovirus (AdV), BK virus (BKV), Cytomegalovirus (CMV), Epstein-Barr virus (EBV), Human herpes virus 6 (HHV-6), or JC virus (JCV).
次要结局
- Number of Participants With Clinically Significant Infections or Episodes of End-Organ Disease Due to Each Virus(Through Week 14)
- Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 26(Through Week 26)