This phase I trial tests the feasibility and safety of genetically modified T cells for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), also referred to as coronavirus disease 2019 (COVID-19) in cancer patients. COVID-19 can cause pneumonia and SARS which can lead to patients requiring intubation and intensive care unit admission. Genetically modified cytotoxic T-lymphocytes (CTLs) are designed to kill a specific virus that can cause infections. The CTLs will be designed to specifically attack the COVID-19 virus. Giving genetically modified CTLs may help to control the infection.
Additional locations may be listed on ClinicalTrials.gov for NCT05101213.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: May Daher
Phone: 713-745-3456
PRIMARY OBJECTIVE:
I. To assess the feasibility and safety of administering genetically engineered glucocorticoid receptor knock out virus specific T cells for COVID-19 related disease in cancer patients.
SECONDARY OBJECTIVES:
I. To obtain preliminary data about the efficacy of administering genetically engineered glucocorticoid receptor knock out virus specific T cells for COVID-19 related disease in cancer patients.
II. To assess the persistence of the administered cells in the patients.
III. To obtain data about relapse free survival (RFS) and overall survival (OS) and cumulative incidence of acute and chronic grade graft-versus-host disease (GVHD).
OUTLINE:
Patients receive COVID-19 specific CTLs intravenously (IV) over 30 minutes on study.
After completion of study treatment, patients are followed up yearly for 15 years.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorMay Daher