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NCT Number: NCT04331275

Viral Specific T-cells for Treatment of Viral Infections After Solid Organ Transplant

The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to treat viral infections that may happen after solid organ transplant (SOT). VSTs are cells specially designed to fight viral infections that may happen after a solid organ transplant. These cells are created from a blood sample collected from the study participant.

Solid organ transplant and the use of immunosuppressive medications reduces the body's ability to fight infections. Viral infections are a common problem after transplant and can cause significant complications. Reduction of immunosuppression may put the organ at risk of rejection. Moreover, treatment of viral infections is expensive and time consuming, with families often administering prolonged treatments with intravenous anti-viral medications, or patients requiring prolonged admissions to the hospital. The medicines can also have side effects like damage to the kidneys or reduction in the blood counts, so in this study the investigators are trying to find a better way to treat these infections and minimize complications.

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This study is active but is not currently recruiting participants.

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Key information

Age range

1 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Blood adenovirus PCR ≥1,000
  • Blood CMV PCR ≥ 500
  • Blood EBV PCR ≥ 1,000
  • Plasma BKV PCR >1,000
  • Plasma JC Virus PCR > 1,000
  • Evidence of invasive adenovirus infection. Adenovirus infection will be defined as the presence of adenoviral positivity as detected by PCR or culture from one site such as stool or blood or urine or nasopharynx. Adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture or PCR from more than 2 sites such as stool or blood or urine or nasopharynx.
  • Evidence of invasive CMV infection, e.g. pneumonitis, retinitis, colitis.
  • Evidence of EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation.
  • Evidence of symptomatic BK virus infection, which may include symptomatic hemorrhagic cystitis, BK viruria or BK nephropathy
  • Evidence of PML or other CNS infection due to JC virus
  • Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent, or a clinically acceptable steroid dose at the discretion of the PI
  • Age > 1 day
  • Must be able to receive VST infusion in Cincinnati

Exclusion criteria

  • Uncontrolled bacterial or fungal infection

Treatment and study plan

Viral Specific T-cells (VSTs)

Biological

VSTs will be infused into solid organ transplant recipients who have evidence of viral infection.

Primary outcomes

  1. Successful production of viral specific T-cells

    Time frame: Within 30 days post culture initiation

    Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.

Secondary outcomes

  1. Presence of viral-specific T-cells

    Time frame: At 30 days after infusion

    Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Hoxworth Blood Center

Registry information

Official study title

Viral Specific T-cells (VSTs) for Treatment of Viral Infections After Solid Organ Transplant

Important dates

Study start
2020
Primary completion
2026
Study completion
2028
First posted
Apr 2, 2020
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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