T-lymphocyte Therapy for Adenovirus Infections
(ADV-VSTS Trial)
Trial Summary
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.
Research Team
Eunkyung Song, MD
Principal Investigator
Nationwide Children's Hospital
Eligibility Criteria
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
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
Treatment Details
Interventions
- Adenovirus Specific T lymphocytes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nationwide Children's Hospital
Lead Sponsor