Start Date
October 31, 2022
Primary Completion Date
May 31, 2023
Study Completion Date
May 31, 2023
Azacitidine Injection
"In Phase Ib dose escalation stage, 24 participants will receive AZA subcutaenously once a day for 5 days as follows:~1. 5 mg/m\^2~2. 15 mg/m\^2~3. 30 mg/m\^2~4. 50 mg/m\^2~5. 75 mg/m\^2~Results from Phase Ib are sent to FDA/IRB for approval before proceeding to Phase IIa. 36 subjects will receive AZA treatment in total (Phase Ib/IIa). Subjects in Phase II will receive a dose that induces two of the three following:~1. a decrease DNA methylation levels in genes previously identified to be persistently hyper-methylated despite successful anti-TB therapy~2. an increase in TNF and IFN-γ signaling pathways~3. an increase in ex vivo mycobacterial growth inhibition assay"
Harris Health System - Ben Taub Hospital, Houston
Collaborators (1)
Bristol-Myers Squibb
INDUSTRY
Andrew Dinardo
OTHER