NCT00891345

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

Enrollment Period

1.2 years

First QC Date

April 30, 2009

Last Update Submit

April 26, 2012

Conditions

Hormone-refractory Prostate Cancer

Keywords

hormone-refractory prostate cancerImmunotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (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.

    Within 7 weeks

Interventions

ALECSATBIOLOGICAL

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

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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).

You may not qualify if:

  • 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.
  • Fertile patients.
  • Patients that have received blood transfusions within 48 hours prior to donation of blood for ALECSAT production.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urological Clinic, Frederikssunds Hospital

Frederikssund, DK-3600, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 41344991DERIVED

Study Officials

  • Hans-Henrik Meyhoff, MD

    Urologisk Klinik, Frederikssund Hospital, Frederikssundsvej 30, 3600 Frederikssund

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2009

First Posted

May 1, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

April 27, 2012

Record last verified: 2012-04

Locations

DK(1)