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.
Additional locations may be listed on ClinicalTrials.gov for NCT03425526.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: David Marin
Phone: 713-792-4179
PRIMARY OBJECTIVE:
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 OBJECTIVE:
I. To obtain preliminary data about the efficacy of administering most closely HLA-matched adenovirus specific T cell lines generated by ex vivo expansion.
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. Patients may also undergo magnetic resonance imaging (MRI) and/or computed tomography (CT)/positron emission tomography (PET) during screening, as well as x-ray and blood sample collection on study.
After completion of study treatment, patients are followed up for 12 months.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorDavid Marin