T-lymphocyte Therapy for Adenovirus Infections
(ADV-VSTS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This open-label, single-arm, phase I/II clinical trial will assess the safety and efficacy of related donor adenovirus-specific T lymphocytes isolated from whole blood or leukapheresis products. The adenovirus-specific T lymphocytes will be generated automatically by the CliniMACS Prodigy using the CliniMACS Cytokine Capture System (IFN-γ) after incubation with MACS GMP PepTivator Peptide Pools of Hexon 5 for enrichment.
Who Is on the Research Team?
Eunkyung Song, MD
Principal Investigator
Nationwide Children's Hospital
Are You a Good Fit for This Trial?
This trial is for people with stubborn adenovirus infections who can't tolerate antiviral drugs due to kidney or bone marrow issues, or have had organ transplants. It's open to ages 0-60 and includes those on recent chemotherapy or immunosuppressants. Pregnant women and those with uncontrolled infections, HIV, or certain drug treatments are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Qualified patients receive ADV-VSTS infusion from haploidentical donors
Follow-up
Participants are monitored for safety and efficacy, including viral load and adverse events
Long-term follow-up
Participants may continue to be monitored for long-term safety and efficacy
What Are the Treatments Tested in This Trial?
Interventions
- Adenovirus Specific T lymphocytes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nationwide Children's Hospital
Lead Sponsor