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

Cincinnati Children's Hospital Medical Center

Status and phase

Active, not recruiting

Phase 2

Conditions

Solid Organ Transplant

Viral Infection

Treatments

Biological: Viral Specific T-cells (VSTs)

Study type

Interventional

Funder types

Other

Identifiers

NCT04331275

2020-0042

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

All

Ages

1+ day old

Volunteers

No Healthy Volunteers

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