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A Phase I Study to Investigate Tolerability and Efficacy of ALECSAT Administered to Glioblastoma Multiforme Patients (ALECSAT-GBM)

Primary Purpose

Glioblastoma Multiforme

Status

Completed

Phase

Phase 1

Locations

Denmark

Study Type

Interventional

Intervention

ALECSAT cell based immunotherapy

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring Glioblastoma Multiforme, Brain cancer, Immunotherapy, Cell based therapy, Autologous cell based therapy, Adoptive immunotherapy, Cytotoxic T cells, Natural Killer cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Recurrence of GBM tumour documented by MRI and PET in patients having received all available standard treatment.
Be over the age of 18 and capable of understanding the information and giving informed consent.
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:

A low blood count (haemoglobin < 6.0 mmol/l).
Lymphocyte counts below 0.8 x 109/l.
Positive tests for anti-HIV-1/2;
Positive tests for HBsAg,
Positive tests for anti-HBc and Anti-HCV.
Syphilis i.e. being positive in a Treponema Pallidum test.
Uncontrolled serious bacterial, viral, fungal or parasitic infection.
Clinically significant autoimmune disorders or conditions of immune suppression.
Treatment with chemotherapy three weeks prior to inclusion in the clinical trial.
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.
Blood transfusions within 48 hours prior to donation of blood for ALECSAT production.
Inclusion in other clinical trials 6 weeks prior to inclusion in the trial.
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.

Sites / Locations

Department of Neurosurgery, Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

One arm

Arm Description

3 doses of ALECSAT cell based immunotherapy planned for all enrolled patients

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Potential clinical effect will be monitored by PET-MRI and SPECT scanning of the brain.

A total of 4 scanannings are performed during the study: 2 PET-MRI scans and 2 SPECT (Single-photon emission computed tomography) scans.

Full Information

NCT ID

NCT01588769

First Posted

April 27, 2012

Last Updated

June 3, 2016

Sponsor

CytoVac A/S

1. Study Identification

Unique Protocol Identification Number

NCT01588769

Brief Title

A Phase I Study to Investigate Tolerability and Efficacy of ALECSAT Administered to Glioblastoma Multiforme Patients

Acronym

ALECSAT-GBM

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CytoVac A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

It is the primary objective of this study to show safety and tolerability for administration of the cell based immunotherapy ALECSAT to patients with Glioblastoma brain cancer. It is a secondary objective to establish if any indications of positive therapeutic or palliative effects may be observed.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma Multiforme

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

One arm

Arm Type

Experimental

Arm Description

3 doses of ALECSAT cell based immunotherapy planned for all enrolled patients

Intervention Type

Biological

Intervention Name(s)

ALECSAT cell based immunotherapy

Intervention Description

I.V. injected Cell Based Medicinal Product, containing between 10 million and one billion autologous Cytotoxic T cells and Natural Killer cells.

Primary Outcome Measure Information:

Title

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Potential clinical effect will be monitored by PET-MRI and SPECT scanning of the brain.

Description

A total of 4 scanannings are performed during the study: 2 PET-MRI scans and 2 SPECT (Single-photon emission computed tomography) scans.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Recurrence of GBM tumour documented by MRI and PET in patients having received all available standard treatment. Be over the age of 18 and capable of understanding the information and giving informed consent. 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: A low blood count (haemoglobin < 6.0 mmol/l). Lymphocyte counts below 0.8 x 109/l. Positive tests for anti-HIV-1/2; Positive tests for HBsAg, Positive tests for anti-HBc and Anti-HCV. Syphilis i.e. being positive in a Treponema Pallidum test. Uncontrolled serious bacterial, viral, fungal or parasitic infection. Clinically significant autoimmune disorders or conditions of immune suppression. Treatment with chemotherapy three weeks prior to inclusion in the clinical trial. 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. Blood transfusions within 48 hours prior to donation of blood for ALECSAT production. Inclusion in other clinical trials 6 weeks prior to inclusion in the trial. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin R Jensen, PhD

Organizational Affiliation

CytoVac A/S (Sponsor)

Official's Role

Study Director

Facility Information:

Facility Name

Department of Neurosurgery, Rigshospitalet

City

Copenhagen

ZIP/Postal Code

DK 2100

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

A Phase I Study to Investigate Tolerability and Efficacy of ALECSAT Administered to Glioblastoma Multiforme Patients

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