A Phase 2/3 Study to Assess the Safety and Efficacy of ALVR105
Research type
Research Study
Full title
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
IRAS ID
308872
Contact name
Andrew Clark
Contact email
Sponsor organisation
AlloVir, Inc.
Eudract number
2021-005105-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 1 days
Research summary
Viral infections and re-activation of dormant viruses in people following a bone marrow transplant can be serious and life-threatening. This study is designed to find out if ALVR105 (Viralym-M) works to prevent viral infections in patients at high risk following bone marrow transplant. This includes viruses caused by new infection or reactivation with BKV (and the related polyomavirus JCV), CMV, human herpesvirus 6 (HHV-6), Epstein-Barr virus (EBV), and Adv. ALVR-105 is a 'cellular therapy' made from virus-specific immune cells called T-cells, collected from healthy donors. These cells must be matched to the patients’ human leukocyte antigen (HLA) type. HLA is a molecule found in cells in the body and is an important part of the immune system that is unique to an individual.
Male and Female participants, aged 1year+, identified as high risk for viral infection following transplant, will be recruited and begin 15-42 days after transplant.
The study includes an open label Phase 2 treatment group and a Phase 3 group.
Approximately 327-337 participants will be enrolled. The first 25-35 participants (open label group) will receive ALVR105 for 14weeks followed by a review by a Data Safety Monitoring Board, on completion of 30days treatment. Following review, participants will be enrolled into the Phase 3 group. Open label participants will continue in the open label group.
Approximately 302 participants in the Phase 3 group will be assigned randomly to receive either ALVR105 or placebo every 2weeks for 14weeks. Participants have 50% chance of receiving ALVR105 and 50% chance of receiving placebo. Neither participants nor their study doctor can choose or know which treatment they receive. The treatment period will be 14weeks followed by 12weeks of follow up. At 52weeks participants will receive post study contact to discuss health status. Procedures for both groups include physical exams, blood/urine samples and ECGs.REC name
North East - York Research Ethics Committee
REC reference
22/NE/0011
Date of REC Opinion
13 May 2022
REC opinion
Further Information Favourable Opinion