Third Party Viral Specific T-cells (VSTs)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2+
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Viral Specific VST Infusion
Biological/VaccineVSTs 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
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Viral Specific VST InfusionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Within 30 days post culture initiation2
Percentage of patients who do not have infusional toxicity
Patients will be monitored for infusional toxicity
Time frame
Through 30 minutes post infusion3
Incidence of GVHD associated with VST infusion
Patients will be monitored for the development of VST associated GVHD
Time frame
Through 30 days after infusionSecondary outcomes
1
Presence of viral-specific T-cells
Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay
Time frame
At 30 days after infusion2
Viral burden
The viral burden will be assessed using the protocol-defined efficacy assessment.
Time frame
At 30 days after infusionSponsors and contacts
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Source ClinicalTrials.gov