Clinical Trial

Pilot Study of Haploidentical Donor Adenovirus Specific T-lymphocytes to Treat Refractory Adenovirus Infections

Study acronym: ADV-VSTS
Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2021-01-22; most recent amendment 2025-05-08.
Status change: Not Yet Recruiting → Recruiting 2022-01-11
Trial Details
NCT Number NCT04722029
Lead Sponsor Nationwide Children's Hospital
Conditions Adenovirus Infection
Enrollment 12 participants
Start Date 2021-10-01
Primary Completion 2026-10-01 (estimated)
Study Completion 2027-10-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-13