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A Phase I Study to Investigate Tolerability and Efficacy of Autologous Lymphoid Effector Cells Specific Against Tumour-cells (ALECSAT) Administered to Patients With Glioblastoma Multiforme (GBM)

Phase 1
18 Years
Not Enrolling
Glioblastoma Multiforme

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Trial Information

A Phase I Study to Investigate Tolerability and Efficacy of Autologous Lymphoid Effector Cells Specific Against Tumour-cells (ALECSAT) Administered to Patients With Glioblastoma Multiforme (GBM)

The primary objective for this study is to establish if any side effects or toxicity issues
occur, that will prevent further clinical development of the autologous cell based
immunotherapy ALECSAT in Glioblastoma (GBM) or to establish if there are side effects or
toxicity issues, that will suggest that the further clinical development planned, has to
change course significantly. It is a primary objective to show safety and tolerability for
administration of ALECSAT, thus not meeting this endpoint, may stop further clinical
development of ALECSAT.

The secondary objective for this study is to establish if any indications of a positive
therapeutic or palliative effect may be observed. As this is a secondary objective, no
observed significant positive clinical effect, will not prevent further clinical development
or in itself, trigger changes in the further clinical development planned.

The overall endpoint of the study is to develop a new therapeutic approach that may slow
down or stop disease progression in late stage GBM patients.

ALECSAT is an autologous cell based immunotherapy based on the patient's own Natural Killer
cells and CytoToxic T cells. The cells are isolated from the patient's own blood - activated
and expanded in number before re administering i. v.

Inclusion Criteria:

1. Recurrence of GBM tumour documented by MRI and PET in patients having received all
available standard treatment.

2. Be over the age of 18 and capable of understanding the information and giving
informed consent.

3. Adequate performance status > 50% (see below*).

- Performance is monitored according to the Karnofsky Performance Score (KPS)

- 100% - normal, no complaints, no signs of disease

- 90% - capable of normal activity, few symptoms or signs of disease

- 80% - normal activity with some difficulty, some symptoms or signs

- 70% - caring for self, not capable of normal activity or work

- 60% - requiring some help, can take care of most personal requirements

- 50% - requires help often, requires frequent medical care

- 40% - disabled, requires special care and help

- 30% - severely disabled, hospital admission indicated but no risk of death

- 20% - very ill, urgently requiring admission, requires supportive measures
or treatment

- 10% - moribund, rapidly progressive fatal disease processes

- 0% - death.

Exclusion Criteria:

1. A low blood count (haemoglobin < 6.0 mmol/l).

2. Lymphocyte counts below 0.8 x 109/l.

3. Positive tests for anti-HIV-1/2;

4. Positive tests for HBsAg,

5. Positive tests for anti-HBc and Anti-HCV.

6. Syphilis i.e. being positive in a Treponema Pallidum test.

7. Uncontrolled serious bacterial, viral, fungal or parasitic infection.

8. Clinically significant autoimmune disorders or conditions of immune suppression.

9. Treatment with chemotherapy three weeks prior to inclusion in the clinical trial.

10. Pregnant women cannot be included in the trial. Fertile women can only be included
with a negative pregnancy test and must use contraceptives during the study.

11. Blood transfusions within 48 hours prior to donation of blood for ALECSAT production.

12. Inclusion in other clinical trials 6 weeks prior to inclusion in the trial.

13. The patient's medical condition is evaluated to be so poor that there is a
significant risk for the patient to be part of the trial and to evaluate any effects
of the treatment.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Observation of tolerability and sideeffects of treatment monitored by objective medical examinations, Karnofsky score and QOL interviews.

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Martin R Jensen, PhD

Investigator Role:

Study Director

Investigator Affiliation:

CytoVac A/S (Sponsor)


Denmark: Danish Medicines Agency

Study ID:




Start Date:

August 2011

Completion Date:

April 2013

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma Multiforme
  • Brain cancer
  • Immunotherapy
  • Cell based therapy
  • Autologous cell based therapy
  • Adoptive immunotherapy
  • Cytotoxic T cells
  • Natural Killer cells
  • Glioblastoma