A Phase I Study to Investigate Tolerability and Efficacy of Autologous Lymphoid Effector Cells Specific Against Tumour-cells (ALECSAT) Administered to Patients With Glioblastoma Multiforme (GBM)
The primary objective for this study is to establish if any side effects or toxicity issues
occur, that will prevent further clinical development of the autologous cell based
immunotherapy ALECSAT in Glioblastoma (GBM) or to establish if there are side effects or
toxicity issues, that will suggest that the further clinical development planned, has to
change course significantly. It is a primary objective to show safety and tolerability for
administration of ALECSAT, thus not meeting this endpoint, may stop further clinical
development of ALECSAT.
The secondary objective for this study is to establish if any indications of a positive
therapeutic or palliative effect may be observed. As this is a secondary objective, no
observed significant positive clinical effect, will not prevent further clinical development
or in itself, trigger changes in the further clinical development planned.
The overall endpoint of the study is to develop a new therapeutic approach that may slow
down or stop disease progression in late stage GBM patients.
ALECSAT is an autologous cell based immunotherapy based on the patient's own Natural Killer
cells and CytoToxic T cells. The cells are isolated from the patient's own blood - activated
and expanded in number before re administering i. v.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Observation of tolerability and sideeffects of treatment monitored by objective medical examinations, Karnofsky score and QOL interviews.
Martin R Jensen, PhD
CytoVac A/S (Sponsor)
Denmark: Danish Medicines Agency