NCT01588769

A Phase I Study to Investigate Tolerability and Efficacy of ALECSAT Administered to Glioblastoma Multiforme Patients

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: CytoVac A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is the primary objective of this study to show safety and tolerability for administration of the cell based immunotherapy ALECSAT to patients with Glioblastoma brain cancer. It is a secondary objective to establish if any indications of positive therapeutic or palliative effects may be observed.

Detailed description

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.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-11-01
• Completion: 2013-04-01
• First posted: 2012-05-01
• Last updated: 2016-06-06

Locations

1 site across 1 country: Denmark