A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of Administering Repeated Doses of ALECSAT to Prostate Cancer Patients.
This study is a prospective open phase I study to investigate the safety and tolerability of
administration of repeated doses 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 repeated administration of ALECSAT, secondarily it will be
observed if changes in PSA levels or any positive anti tumor effect may be observed. The
study has the purpose to investigate whether repeated treatment with ALECSAT in any way is
Trial Design: The study is an open, prospective phase I safety study of ALECSAT in prostate
A group consisting of 4 patients will be treated twice 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 to the third treatment for these
patients and with 14 more patients that will be treated with ALECSAT according to the
protocol. Thus this study will include a total of 20 patients.
The patients will after the first administration of ALECSAT be hospitalized for 2 days. Five
and 10 weeks later the patients will be hospitalized for 1 day and receive the second and
third administration of ALECSAT. Each patient will furthermore be followed closely for 12
weeks after the third treatment. During the course of the entire study the patients will be
monitored by 11 planned study visits, by the investigators at Urologisk Klinik at
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 repeated administration of ALECSAT to enable further clinical development of the ALECSAT therapy.
To show safety and tolerability patients will be monitored closely after administration of ALECSAT and during the follow up period. Heart rate, temperature, blood pressure, Performance status will be monitored. Blood samples will be analysed for: PSA, ALP, LDH, CREAT and Standard haematology: Blood picture (complete blood count, haemogram), leucocytes, Differential count, electrolytes, renal function, and liver count (liver enzymes). The number of patients experiencing adverse events (AE), the number and duration of the AE will be reported as a measure of safety and tolerability.
Within 12 weeks
Hans-Henrik Meyhoff, MD
Urologisk Klinik, Frederikssund Hospital, Frederikssundsvej 30, 3600 Frederikssund
Denmark: Danish Medicines Agency