Third Party Viral Specific T-cells (VSTs)

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Aug 21, 2015

Keywords

ClinConnect Summary

This clinical trial is studying a treatment using virus-specific T-cells (VSTs), which are a type of white blood cell that helps fight off viral infections. The goal is to see if T-cells from a donor who is not related to the patient can be safely given to people who are struggling with viral infections, especially those who have weakened immune systems. This is particularly important for patients who may have had illnesses like cancer or who have undergone procedures like stem cell transplants.

To be eligible for this trial, participants need to be at least 1 day old and must have a viral infection or reactivation while being immunocompromised. Those who have had a stem cell transplant should be at least 21 days post-treatment and must be in a stable condition to reduce steroid medications to a low dose. Participants will receive the T-cell infusion in Cincinnati, and it’s essential that they provide consent to join the trial. It’s important to note that individuals with certain complications, such as severe graft-versus-host disease or uncontrolled infections, may not be able to participate. Overall, the trial aims to offer a potential new option for patients dealing with difficult viral infections.

Gender

ALL

Eligibility criteria

• 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