NCT01070797

Administration of Rapidly Generated Multivirus-specific Cytotoxic T-Lymphocytes for the Prophylaxis and Treatment of EBV, CMV, and Adenovirus Infection Post Allogeneic Stem Cell Transplant (VIRAGE)

Completed Phase 1 Last updated 2 September 2014

What this trial tests

Phase 1 trial testing Multi-virus Specific T cells in Adenovirus Infection in 10 participants. Completed in 1 April 2014.

Timeline

1 January 2011

Primary endpoint
1 May 2013

1 April 2014

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 January 2011
Primary completion	1 May 2013
Estimated completion	1 April 2014
Sites	2 locations across United States

Drugs / interventions tested

• Multi-virus Specific T cells — full drug profile →

Conditions studied

• Adenovirus Infection — all drugs for Adenovirus Infection →
• Epstein-Barr Virus Infections — all drugs for Epstein-Barr Virus Infections →
• Cytomegalovirus Infections — all drugs for Cytomegalovirus Infections →
• Stem Cell Transplant — all drugs for Stem Cell Transplant →

Sponsor

Baylor College of Medicine

Who can join

Eligibility, any sex, with Adenovirus Infection or Epstein-Barr Virus 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 dose limiting toxicity in subjects receiving rapidly-generated donor-derived multivirus-specific CTLs
  Time frame: 42 days
  Safety and toxicity outcomes including DLTs, GvHD, clinical signs of viral infections, secondary graft failure and laboratory measurements will be summarized using descriptive statistics for each dose level (frequency table, means, standard deviations, medians and ranges).
• Determine the effect of rCTL infusion on viral load
  Time frame: 1 year
  Primary endpoint for the phase II portion of the study is antiviral efficacy, and is whether the institution of additional antiviral therapy post rCTL is needed.

Sponsor's own description

Patient's on this protocol have a type of blood cell cancer, other blood disease or a genetic disease and have received a stem cell transplant. The donor of the stem cells was either a brother or sister, another relative, or a closely matched unrelated donor. The patient is being asked to participate in this study which tests if blood cells from the donor that have been grown in a special way, can prevent or be an effective treatment for early infection by three viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV) and adenovirus.

Adenovirus is a virus that usually causes symptoms of a common cold, but can cause serious life-threatening infections in patients who have weak immune systems. It can affect the lungs and cause very serious pneumonia, and can also damage the gut, liver, pancreas and eyes.CMV can also 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. Approximately 2/3 of normal people harbor this virus in their body. In healthy people CMV rarely causes any problems because the immune system can keep it under control, but after a transplant, the risk of developing CMV disease is much higher because the immune system is so weak. EBV is the virus that causes glandular fever. It is also a life long infection like CMV that is normally controlled by the immune system. When immunity is weak, the virus can become active and cause fevers, enlarged lymph nodes and sometimes a type of cancer called lymphoma.

Investigators want to see if a kind of white blood cell called T lymphocytes (T cells)can be used to prevent and treat adenovirus, CMV and EBV in the early stages of reactivation or infection. T cells have been grown from the patient's stem cell donor in the laboratory in a way that will train them to recognize the virus and control it when they are given after a transplant. This treatment with specially trained T cells (also called CTLs) has had activity against these viruses in previous studies and in this study investigators want to see if they still have activity when they are made in a simpler and faster way. These donor-derived multivirus-specific special cell lines are an investigational product not approved by the Food and Drug Administration.

The purpose of this study is to evaluate whether donor-derived multivirus-specific special cell lines are safe and can control three viruses: EBV, CMV and adenovirus.

Publications & conference data

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

1. Safety and clinical efficacy of rapidly-generated trivirus-directed T cells as treatment for adenovirus, EBV, and CMV infections after allogeneic hematopoietic stem cell transplant.
   Gerdemann U, Katari UL, Papadopoulou A, Keirnan JM, et al · · 2013 · cited 171× · PMID 23783429 · DOI 10.1038/mt.2013.151
2. Treating Adenovirus Infection in Transplant Populations: Therapeutic Options Beyond Cidofovir?
   Narsana N, Ha D, Ho DY. · · 2025 · cited 2× · PMID 40431613 · DOI 10.3390/v17050599
3. Cellular Therapies in Transplantation - Regulatory T Cell Therapies and Virus Specific Therapies.
   Hannouneh ZA, Merzkani M, Hsieh CS, Murakami N. · · 2025 · PMID 41058937 · DOI 10.1007/s40472-025-00489-1