Phase 3 ALVR105 for AdV Infection following HC Transplantation
Research type
Research Study
Full title
Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial, with Cross-Over, of Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
IRAS ID
305709
Contact name
Richard Reise
Contact email
Sponsor organisation
AlloVir, Inc.
Eudract number
2021-003450-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 1 days
Research summary
During the period of immune recovery after allogeneic hematopoietic cell transplant, viral infections and reactivations can happen including those with adenovirus (AdV). AdV can be an important cause of disease and death in patients who have undergone allogenic hematopoietic stem cell transplant. One out of 3 children and approximately 6% of adults are reported to have an AdV infection within 6 months after allogeneic hematopoietic Cell transplantation.
This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will look at the safety and benefit of posoleucel (ALVR105) for the treatment of AdV infection in paediatric (children) and adult who have had an allogeneic hematopoietic cell transplantation whilst receiving standard of care.
Randomized, double-blind, placebo-controlled study means that neither the patient nor the study doctor will know which medication is being given.
Approximately 80 participants at approximately 40 clinical sites in the US and Europe will be enrolled into the study and randomized 1:1 to receive posoleucel (ALVR105) or placebo.
This study is sponsored by AlloVir.
REC name
North East - York Research Ethics Committee
REC reference
21/NE/0221
Date of REC Opinion
26 Jan 2022
REC opinion
Further Information Favourable Opinion