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New treatment option for Viral Infection
Official title Third Party Viral Specific T-cells (VSTs)
ClinicalTrials.gov ID: NCT02532452
What this study is testing
What is Viral Specific VST Infusion?
Viral Specific VST Infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for viral infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Akron, Ohio, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 days and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Akron, Ohio, United States; Cincinnati, Ohio, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.