Glioblastoma MultiformePhase 1ALECSAT-GBMNCT01588769
A Phase I Study to Investigate Tolerability and Efficacy of ALECSAT Administered to Glioblastoma Multiforme Patients
A Phase 1 study testing ALECSAT cell based immunotherapy in people with Glioblastoma Multiforme, run by CytoVac A/S at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- ALECSAT cell based immunotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2011to Apr 2013
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Glioblastoma Multiforme
- Being tested
- ALECSAT cell based immunotherapy
- Keywords
- Glioblastoma Multiforme, Brain cancer, Immunotherapy, Cell based therapy, Autologous cell based therapy, Adoptive immunotherapy, Cytotoxic T cells, Natural Killer cells
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALECSAT cell based immunotherapyBiological
I.V. injected Cell Based Medicinal Product, containing between 10 million and one billion autologous Cytotoxic T cells and Natural Killer cells.
| Study group | Role | What they receive |
|---|---|---|
| One arm | Experimental | 3 doses of ALECSAT cell based immunotherapy planned for all enrolled patients Receives: Biological: ALECSAT cell based immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation of tolerability and sideeffects of treatment monitored by objective medical examinations, Karnofsky score and QOL interviews.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startAug 2011
- Primary completionNov 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytoVac A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin R Jensen, PhD, Study director, CytoVac A/S (Sponsor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588769
- Sponsor's protocol ID
- CV003
- Other IDs
- 2011-002180-22
- Acronym
- ALECSAT-GBM
- Status last verified
- Jun 2016
- First submitted
- 27 Apr 2012
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01588769
- Acronym / sponsor ID
- ALECSAT-GBM / CV003
- Conditions
- Glioblastoma Multiforme
- Keywords
- Glioblastoma Multiforme, Brain cancer, Immunotherapy, Cell based therapy, Autologous cell based therapy, Adoptive immunotherapy, Cytotoxic T cells, Natural Killer cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- CytoVac A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 1 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One arm | Experimental | Biological: ALECSAT cell based immunotherapy3 doses of ALECSAT cell based immunotherapy planned for all enrolled patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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*).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALECSAT cell based immunotherapyI.V. injected Cell Based Medicinal Product, containing between 10 million and one billion autologous Cytotoxic T cells and Natural Killer cells. | Biological | One arm |
Primary outcome
Observation of tolerability and sideeffects of treatment monitored by objective medical examinations, Karnofsky score and QOL interviews.
Time frame: 3 months
1 secondary outcome
Potential clinical effect will be monitored by PET-MRI and SPECT scanning of the brain.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin R Jensen, PhD study director
CytoVac A/S (Sponsor)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALECSAT cell based immunotherapy in people with Glioblastoma Multiforme, 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 15 inclusion and 13 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 6 Jun 2016. 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?
Observation of tolerability and sideeffects of treatment monitored by objective medical examinations, Karnofsky score and QOL interviews. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2016.