AzTrials
AzTrials

Hormone-refractory Prostate CancerPhase 1ALECSATNCT00891345

Safety Study of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy

A Phase 1 study testing ALECSAT in people with Hormone-refractory Prostate Cancer, run by CytoVac A/S at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is a phase I study of a new cell based prostate cancer therapy (ALECSAT). 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Hormone-refractory Prostate Cancer
What is being tested?
ALECSAT
Type of treatment
Injection or infusion
How many people
13 participants
Where
1 siteDenmark
Study dates
Apr 2009to Jul 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hormone-refractory prostate cancer patients
  • Three consecutive rises of PSA min. 2 weeks apart, resulting in at least two 50% increases over the PSA nadir.
  • Antiandrogen withdrawal for at least 4 weeks, or
  • PSA progression despite secondary hormonal manipulations, or
  • Progression of osseous or soft tissue lesions.
  • Serum castration levels of testosterone.
Show all 9Show fewer
  • Be capable of understanding the information and giving informed consent.
  • Expected survival time (life expectancy) of over 4 months.
  • Adequate performance status (WHO / ECOG Performance status score 2 or less).

Who cannot join

  • Patients with a low blood count (haemoglobin < 6.0 mmol/l).
  • Patients with lymphocyte-numbers below 0.8.
  • Patients known to be HIV and/or hepatitis positive i.e. patients positive in tests for anti-HIV-1/2; HBsAg, anti-HBc and Anti-HCV.
  • Patients known to have syphilis i.e. being positive in a Treponema Pallidum test.
  • Patients with uncontrolled serious bacterial, viral, fungal or parasitic infection.
  • Patients must have no clinically significant autoimmune disorders or conditions of immune suppression.
Show all 11Show fewer
  • Patients that have been treated with corticosteroids (steroid hormones) or bisphosphonates or have been in chemotherapy or radiation treatment one month prior to inclusion in the clinical trial.
  • Fertile patients.
  • Patients that have received blood transfusions within 48 hours prior to donation of blood for ALECSAT production.
  • Patients must not have been included in other clinical trials 6 weeks prior to inclusion in the trial or be enrolled in other clinical trials during the ALECSAT clinical trial.
  • Any medical condition that will render participation in the study risky or, according to the investigator in charge, will make the assessment of side-effects difficult.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Urological Clinic, Frederikssunds Hospital

    Frederikssund, DK-3600

Other trials in Denmark

About this study

Official title: 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 phase I study of a new cell based prostate cancer therapy (ALECSAT). 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 this type of therapy. It is the hypothesis that the cells administered during the therapy will attack the tumour cells and in this way stop or slow down the progression of disease.

Read the detailed description

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 cancer patients.

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.

Being tested
ALECSAT
Keywords
hormone-refractory prostate cancer, Immunotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALECSATBiological

    Autologous activated CTL and NK-cells injected as a single intravenous injection.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary endpoint is to show safety and tolerability for the administration of ALECSAT to enable further clinical development of the ALECSAT therapy.

    Measured: Within 7 weeks

Secondary outcomes (1)

  1. The secondary endpoint for this study is to establish if any indications of a positive therapeutic effect on the prostate cancer may be observed.

    Measured: Within 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00891345
Sponsor's protocol ID
CV001
Acronym
ALECSAT
Status last verified
Apr 2012
First submitted
30 Apr 2009
Last updated
27 Apr 2012
Results posted
No
Data monitoring committee
No

Publications

  • Gammelgaard OL, Ehmsen S, Jylling AMB, Sandberg L, Kirkin AF, Kodahl AR, Ditzel HJ. Adoptive cell transfer therapy with ex vivo primed peripheral lymphocytes in combination with chemotherapy in locally advanced or metastatic triple-negative breast cancer: the ImmunoBreast phase Ib clinical trial. J Immunother Cancer. 2025 Dec 4;13(12):e012213. doi: 10.1136/jitc-2025-012213.

    PubMed 41344991

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ALECSAT in people with Hormone-refractory Prostate Cancer, run by CytoVac A/S at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoint is to show safety and tolerability for the administration of ALECSAT to enable further clinical development of the ALECSAT therapy. (time frame: Within 7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00891345, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in