Trials / Terminated
TerminatedNCT05305040
Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
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
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 451 (actual)
- Sponsor
- AlloVir · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Adenovirus Infection
- BK Virus Infection
- Cytomegalovirus Infections
- Epstein-Barr Virus Infections
- Human Herpes Virus-6 Infection
- JC Virus Infection
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Posoleucel (ALVR105) | Administered as 2-4 milliliter infusion, visually identical to placebo |
| BIOLOGICAL | Placebo | Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105) |
Timeline
- Start date
- 2022-03-24
- Primary completion
- 2024-01-30
- Completion
- 2024-01-30
- First posted
- 2022-03-31
- Last updated
- 2024-05-16
- Results posted
- 2024-05-16
Locations
88 sites across 10 countries: United States, Australia, Belgium, Canada, France, Italy, South Korea, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05305040. Inclusion in this directory is not an endorsement.