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RECRUITING
NCT04722029
PHASE1/PHASE2

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

Sponsor: Nationwide Children's Hospital

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.

Official title: Open-Label Pilot Study of Haploidentical Donor Adenovirus Specific T Lymphocytes (ADV-VSTS) for the Treatment of Refractory Adenovirus Infection and/or Disease in Hospitalized Patients

Key Details

Gender

All

Age Range

Any - 60 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2021-10-01

Completion Date

2027-10-01

Last Updated

2025-05-13

Healthy Volunteers

No

Interventions

BIOLOGICAL

Adenovirus Specific T lymphocytes

ADV-VSTs is being proposed for the treatment of refractory ADV infection and/or disease in these populations using haploidentical donors for ease of donor selection, antiviral immunity, coupled with a high-throughput antigen stimulation/IFN-γ capture system (Miltenyi Biotec, CliniMACS Prodigy® System) for rapid and less costly isolation of ADV-VSTs.

Locations (1)

Nationwide Children's Hospital

Columbus, Ohio, United States