NCT03266627

Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection

A Pilot Study in the Treatment of Refractory Adenovirus (ADV) Infection With Related Donor ADV Cytotoxic T-Lymphocytes (ADV-CTLs)in Children, Adolescents and Young Adult Recipients

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: New York Medical College · Academic / Other
• Sex: All
• Age: 1 Month – 79 Years
• Healthy volunteers: Not accepted

Summary

Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in children, adolescents and young adults with refractory ADV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant. Funding Source: FDA OOPD

Conditions

• Adenovirus
• Primary Immune Deficiency Disorder

Interventions

Type	Name	Description
DRUG	cytotoxic t-lymphocytes	adenovirus specific cytotoxic t-lymphocytes will be collected and manufactured from HLA matched related or HLA mis-matched related donors and administered to eligible patients with refractory adenovirus or PID.

Timeline

• Start date: 2018-11-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2017-08-30
• Last updated: 2025-08-08

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study