NCT03266640

Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)

A Pilot Study in the Treatment of Refractory Cytomegalovirus (CMV) Infections With Related Donor CMV Specific Cytotoxic T-cells (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

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

Conditions

• Cytomegalovirus Infections
• Primary Immune Deficiency Disorder

Interventions

Type	Name	Description
DRUG	viral specific cytotoxic t-lymphocytes	CMV specific CTLs will be collected from HLA matched or mismatched donors and manufactured in a GMP facility and administered to patients with refractory CMV infection.

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

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study