Phase 3 study of Viralym-M in patients with virus associated HC
Research type
Research Study
Full title
Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant
IRAS ID
279265
Contact name
Karl Peggs
Contact email
Sponsor organisation
AlloVir, Inc.
Eudract number
2020-000722-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Hemorrhagic cystitis (HC) is caused by a viral infection after allogeneic hematopoietic cell transplant (HCT). In healthy individuals, T cell immunity defends against viruses. For allogeneic HCT recipients, the use of immunosuppressive therapies lowers the activity of the body’s immune system and reduces its ability to fight infections. These patients are susceptible to inflammation caused by virus and normally have bladder infection which results in pain and blood in the urine. Viralym-M (ALVR105) is a research medicine that contains T-cells made from healthy human donors to help HC patient against specific viruses.
The purpose of this study is to determine if ALVR105 is safe and a good treatment for HC. The study will compare ALVR105 to placebo in reducing bladder pain, reducing the amount of blood in urine, and seeing if specific viruses are lowered in blood and urine. The placebo looks like the research medicine but does not contain any T-cells (the active ingredient of the treatment). Patients in this study will receive either ALVR105 or placebo.
This is a randomised, placebo-controlled, double−blind study meaning neither the patient nor the study doctor will know which medication is being given.
AlloVir, Inc. is sponsoring this multicentre study and it is anticipated that approximately 125 participants will be randomised in a 3:2 ratio to receive 2 sequential infusions of Viralym-M cells or placebo.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/LO/1072
Date of REC Opinion
1 Dec 2020
REC opinion
Further Information Favourable Opinion