A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of Administering ALECSAT to Prostate Cancer Patients - a First Dose in Man Study
This study is a prospective open phase I study to investigate the safety and tolerability of
administration of a single dose of a cell based medicinal product (CBMP) ALECSAT.
ALECSAT is an autologous CBMP that is made from the patient's own blood cells. ALECSAT
contains a large amount of tumour specific cytotoxic Lymphocytes (CTL) and Natural Killer
(NK) cells that are isolated activated and amplified in number.
The CBMP is given as a slow i. v. injection to patients with prostate cancer. The patients
are in the late stage of the disease where they have received hormone treatment but their
disease is progressing.
The primary objective of the study is to observe if any side effects or tolerability issues
occur as a consequence of the cell administration, secondarily it will be observed if any
positive anti tumour effect may be observed. The study has the purpose to investigate
whether treatment with ALECSAT in any way is toxic.
Trial Design: The study is an open, prospective phase I safety study of ALECSAT in prostate
A group consisting of 6 patients will be treated with ALECSAT according to the protocol.
Then an interim analysis will be done. If there are no signs of significant toxicity related
to the treatment, the study will continue with 8 more patients that will be included and
treated with ALECSAT according to the phase I protocol. Thus this study will include a total
of 14 patients.
The patients will after a single administration of ALECSAT be hospitalised for 3 days and
will furthermore be followed closely for 7 weeks by 5 planned study visits, by the
investigators at Urologisk Klinik at Fredrikssund Hospital.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint is to show safety and tolerability for the administration of ALECSAT to enable further clinical development of the ALECSAT therapy.
Within 7 weeks
Hans-Henrik Meyhoff, MD
Urologisk Klinik, Frederikssund Hospital, Frederikssundsvej 30, 3600 Frederikssund
Denmark: Danish Medicines Agency