Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial

Official title: Administration of Off-the-Shelf, Expanded, Most Closely HLA Matched, Third Party Adenovirus Specific T Cells for Therapy of Adenovirus Related Disease in Immunocompromised Patients

Status Recruiting

Clinical Trial Summary

This phase I trial studies the side effects of allogeneic adenovirus-specific cytotoxic T lymphocytes (donor T cell therapy) and to see how well they work in treating patients with a weakened immune system (immunocompromised) and adenovirus-related disease. Allogeneic adenovirus-specific cytotoxic T lymphocytes are made from donated blood cells grown in the laboratory and are designed to kill viruses that can cause infections in immunocompromised patients with adenovirus-related disease.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess the feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched adenovirus specific T cell lines generated by ex vivo expansion as therapy of asymptomatic adenovirus viremia or adenovirus-related disease in immunocompromised hosts.

SECONDARY OBJECTIVES:

I. To obtain preliminary data about the efficacy of administering most closely HLA-matched adenovirus specific T cell lines generated by ex vivo expansion as therapy of adenovirus viremia or adenovirus-related disease.

II. To assess the persistence of the administered cells in the patients.

OUTLINE:

Within two weeks of enrollment, patients receive allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs) intravenously (IV) over 30 minutes. Patients may receive additional allogeneic adenovirus-specific CTL infusions at the discretion of the investigator in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 12 months. ;

Related Conditions & MeSH terms

• Adenoviridae Infections
• Hematopoietic and Lymphoid Cell Neoplasm
• Immunocompromised

• NCT number: NCT03425526
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Contact: David Marin, MD
• Phone: 713-792-8750
• Email: dmarin@mdanderson.org
• Status: Recruiting
• Phase: Phase 1
• Start date: March 15, 2018
• Completion date: January 1, 2027