drugset / Trial / NCT04722029

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

NCT04722029

Phase 1/2 Recruiting 12 enrolled Nationwide Children's Hospital
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-10-01
Primary completion
2026-10-01
Completion
2027-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Adenovirus Specific T- Lymphocytes Cell therapy 50000 cells/kg Other