NCT02313857

A Phase I Study Using Most Closely HLA-matched Cytomegalovirus-specific T Lymphocytes for the Treatment of Cytomegalovirus Infections Post-allogeneic Stem Cell Transplant(VIRALYM-C)

Completed Phase 1 Last updated 21 December 2018

What this trial tests

Phase 1 trial testing Viralym-C in CMV Infections in 10 participants. Completed in 1 February 2018.

Timeline

1 September 2015

Primary endpoint
1 May 2017

1 February 2018

Quick facts

Lead sponsor	AlloVir
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 September 2015
Primary completion	1 May 2017
Estimated completion	1 February 2018
Sites	2 locations across United States

Drugs / interventions tested

• Viralym-C — full drug profile →

Conditions studied

• CMV Infections — all drugs for CMV Infections →

Sponsor

AlloVir — full company profile →

Who can join

Eligibility, any sex, with CMV Infections. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Assessment of patients with adverse events after Viralym-C infusion
  Time frame: 42 days
  To determine if administration of banked CMV-specific T cells (Viralym-C) derived from healthy donors are safe in patients with CMV infection after allogeneic stem cell transplant.

Sponsor's own description

Patients enrolled on this study will have received a stem cell transplant. After a transplant, while the immune system grows back the patient is at risk for infection. Some viruses can stay in the body for life, and if the immune system is weakened (like after a transplant), they can cause life-threatening infections.

CMV can cause serious infections in patients with weak or suppressed immune systems. It usually affects the lungs, causing a very serious pneumonia, but it can also affect the gut, the liver and the eyes.

Investigators want to see if they can use a kind of white blood cell called T cells to treat CMV infections that occur after a transplant. Investigators have observed in other studies that treatment with specially trained T cells has been successful when the cells are made from the transplant donor. However as it takes 1-2 months to make the cells, that approach is not practical when a patient already has an infection.

Investigators have now generated CMV-specific T cells from the blood of healthy donors and created a bank of these cells. Investigators have previously successfully used frozen virus-specific T cell lines generated from healthy donors to treat virus infections after bone marrow transplant, and have now improved the production method and customized the bank of lines to specifically and exclusively target CMV.

In this study, investigators want to find out if the banked CMV-specific T cells derived from healthy donors are safe and can help to treat CMV infection.

The CMV-specific T cells (Viralym-C) are an investigational product not approved by the Food and Drug Administration (FDA).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Innovation and trends in the development and approval of antiviral medicines: 1987-2017 and beyond.
   Chaudhuri S, Symons JA, Deval J. · · 2018 · cited 136× · PMID 29758235 · DOI 10.1016/j.antiviral.2018.05.005
2. "Mini" bank of only 8 donors supplies CMV-directed T cells to diverse recipients.
   Tzannou I, Watanabe A, Naik S, Daum R, et al · · 2019 · cited 35× · PMID 31481503 · DOI 10.1182/bloodadvances.2019000371