Radiation/Temozolomide and Immunotherapy With Daratumumab to Improve Antitumor Efficacy in Glioblastoma
Status:
Not yet recruiting
Trial end date:
2024-08-01
Target enrollment:
Participant gender:
Summary
TMZ is a standard therapy for GBM. The study will demonstrate that Daratumumab can
collaborate with TMZ to enhance the cytotoxicity against GBM cells. Collectively, the
preclinical data along with existing in vivo studies by others provides the rationale for
therapeutic targeting of CD38 in GBM and its microenvironment. Daratumumab is commercially
available, is safe and well tolerated when combined with alkylating chemotherapy, radiation
therapy and has attained therapeutic CSF levels. Thus, the addition of Daratumumab to the
frontline treatment regimen of GBM can potentially have a significant clinical benefit.
Approximately 16 subjects will be enrolled in this trial. Up to 6 will be enrolled in the
phase I part and 10 to 13 in the phase II part to come up with a total of 16 patients with 2
phases combined.