Status:
ACTIVE_NOT_RECRUITING
Viral Specific T-cells for Treatment of Viral Infections After Solid Organ Transplant
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Hoxworth Blood Center
Conditions:
Solid Organ Transplant
Viral Infection
Eligibility:
All Genders
1+ years
Phase:
PHASE2
Brief Summary
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 sp...
Eligibility Criteria
Inclusion
- 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
- Uncontrolled bacterial or fungal infection
Key Trial Info
Start Date :
August 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2028
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04331275
Start Date
August 18 2020
End Date
September 1 2028
Last Update
November 5 2025
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229