Third Party Viral Specific T-cells (VSTs)
Third Party Viral Specific T-cells (VSTs) for Treatment of Viral Infections in Immunocompromised Patients
Children's Hospital Medical Center, Cincinnati
750 participants
Sep 2, 2015
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections.
Eligibility
Inclusion Criteria6
- Immunocompromised patient with evidence of viral infection or reactivation
- Age \>1 day
- Recipients who have had a stem cell transplant must be at least 21 days after stem cell infusion
- Clinical status must allow tapering of steroids to \< 0.5mg/kg prednisone or other steroid equivalent
- Must be able to receive CTL infusion in Cincinnati
- Informed consent obtained by PI or sub-investigator either in person or by phone
Exclusion Criteria5
- Active acute GVHD grades II-IV
- Uncontrolled bacterial or fungal infection
- Uncontrolled relapse of malignancy requiring treatment with chemotherapy
- Infusion of ATG or alemtuzumab within 2 weeks of VST infusion
- Biopsy confirmed acute rejection of solid organ transplant OR empiric treatment of suspected but not confirmed acute rejection of solid organ transplant within the last 30 days
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Interventions
VSTs will be infused into immunocompromised patients with evidence of viral infection or reactivation defined as any of the following: * Blood adenovirus PCR ≥ 1,000 * Blood CMV PCR ≥ 500 * Blood EBV PCR ≥ 9,000 * Plasma BKV PCR \>1,000 * Plasma JC Virus PCR \> 1,000 * Evidence of invasive adenovirus infection or disease, defined as the presence of adenoviral positivity by PCR or culture in one or more sites * Evidence of invasive CMV infection, eg pneumonitis, retinitis, colitis * Evidence of invasive EBV disease/infection, 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, or EBV-associated malignancies * Evidence of symptomatic BK virus infection, which may include symptomatic hemorrhagic cystitis, or BK nephropathy * Evidence of PML or other CNS infection due to JC virus
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02532452