A Phase I Study to Investigate Tolerability and Efficacy of ALECSAT Administered to Glioblastoma Multiforme Patients (ALECSAT-GBM)
|Glioblastoma Multiforme||Biological: ALECSAT cell based immunotherapy||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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)|
- Observation of tolerability and sideeffects of treatment monitored by objective medical examinations, Karnofsky score and QOL interviews. [ Time Frame: 3 months ]
- Potential clinical effect will be monitored by PET-MRI and SPECT scanning of the brain. [ Time Frame: 3 months ]A total of 4 scanannings are performed during the study: 2 PET-MRI scans and 2 SPECT (Single-photon emission computed tomography) scans.
|Study Start Date:||August 2011|
|Study Completion Date:||April 2013|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Experimental: One arm
3 doses of ALECSAT cell based immunotherapy planned for all enrolled patients
Biological: ALECSAT cell based immunotherapy
I.V. injected Cell Based Medicinal Product, containing between 10 million and one billion autologous Cytotoxic T cells and Natural Killer cells.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588769
|Department of Neurosurgery, Rigshospitalet|
|Copenhagen, Denmark, DK 2100|
|Study Director:||Martin R Jensen, PhD||CytoVac A/S (Sponsor)|