Infusion of donor-derived T-cells for viral infections in immunocompromised patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to generate viral specific T-cells (VSTs) from unrelated donors to treat immunocompromised patients suffering from viral infections such as Epstein-Barr virus (EBV), cytomegalovirus (CMV), and adenovirus (ADV). Blood will be collected from donors to create these T-cells, which will then be infused into patients based on their HLA type and the specific viral infection they are facing. The goal is to demonstrate the safety and efficacy of this approach in managing viral reactivation and infections in vulnerable populations, particularly children who have undergone stem cell transplants.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

* 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

Where it's running

• Akron Children's Hospital
  Akron, Ohio, United States Recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting
• The Ohio State University Wexner Medical Center - James Cancer Hospital
  Columbus, Ohio, United States Recruiting
• University of Cincinnati Medical Center
  Cincinnati, Ohio, United States Completed

Study contacts

• Principal investigator: Michael Grimley, MD, MD — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Jamie Wilhelm
• Email: Jamie.Wilhelm@cchmc.org
• Phone: (513) 803-1102

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using donor-derived T-cells to treat viral infections after stem cell transplants

  This study is testing whether T-cells from stem cell donors can help patients who have infections after their transplants fight off those viruses.

  Recruiting at 2 sites Phase 1/2 Children's Hospital Medical Center, Cincinnati · Akron, Ohio and 2 other locations · NCT02048332

• Biomarkers linked to congenital CMV using newborn blood spots

  Researchers will test protein and RNA markers in dried blood spots from newborns to see if they can identify congenital CMV sequelae early.

  Recruiting at 2 sites Copenhagen University Hospital, Rigshospitalet · Copenhagen and 1 other locations · NCT07635368

• Investigating how cold viruses affect bronchiectasis exacerbations

  This study is trying to see if cold viruses make symptoms worse for people with bronchiectasis compared to healthy individuals.

  Recruiting Imperial College London · London · NCT06931002

• Controlled exposure to a viral mimic for studying lung immune responses

  This study tests how people with asthma and healthy volunteers respond to a safe viral mimic to help understand and improve treatments for lung inflammation and asthma.

  Recruiting Cambridge University Hospitals NHS Foundation Trust · Cambridge, Cambridgeshire · NCT06488118

• HEPA air cleaners in inner-city elementary school classrooms

  This trial will test whether placing HEPA air cleaners in elementary classrooms lowers airborne virus levels and reduces infections among students, teachers, and household members.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT05953233

• Effects of mouthrinse on oral and gut bacteria and viruses

  This study is testing how two popular mouthwashes affect the bacteria and viruses in your mouth and gut over six months.

  Recruiting University of California, Irvine · Irvine, California · NCT05603650

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.