At a glance
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A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of Administering Repeated Doses of ALECSAT to Prostate Cancer Patients.
In Brief
A Phase 1 clinical trial evaluating ALECSAT for Hormone-refractory Prostate Cancer. Completed, enrolled 21 participants across 1 site.
Detailed Summary
This study is a phase I study of a cell based prostate cancer therapy, Autologous Lymphoid Effector Cells Specific Against Tumor-cells (ALECSAT). Safety and tolerability of a single dose has been shown in 13 prostate cancer patients. In this study 20 prostate cancer patients will receive 3 doses of the ALECSAT treatment. In this therapy specific cells from the patient's own immune system are isolated, activated and re-administered to the patient to boost a specific immune response against the cancer cells. The aim of the study is to show safety and tolerability for repeated dosing of this type of therapy. It is the hypothesis that the cells administered during the therapy will attack the tumor cells and in this way stop or slow down the progression of disease.
Study Details
Timeline
Interventions
Autologous activated CTL and NK-cells injected as three intravenous injections interspaced by 5 weeks.