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

Study Overview
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Brief Summary
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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.

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

Conditions
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Solid Organ Transplant, Viral Infection

Intervention / Treatment
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* Biological: Viral Specific T-cells (VSTs)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Viral Specific T-cells (VSTs)<br> | Biological: Viral Specific T-cells (VSTs)<br>* VSTs will be infused into solid organ transplant recipients who have evidence of viral infection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful production of viral specific T-cells | Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria. | Within 30 days post culture initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of viral-specific T-cells | Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay | At 30 days after infusion |