- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01588769
A Phase I Study to Investigate Tolerability and Efficacy of ALECSAT Administered to Glioblastoma Multiforme Patients (ALECSAT-GBM)
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Copenhagen, Denmark, DK 2100
- Department of Neurosurgery, Rigshospitalet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: One arm
3 doses of ALECSAT cell based immunotherapy planned for all enrolled patients
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I.V. injected Cell Based Medicinal Product, containing between 10 million and one billion autologous Cytotoxic T cells and Natural Killer cells.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Observation of tolerability and sideeffects of treatment monitored by objective medical examinations, Karnofsky score and QOL interviews.
Time Frame: 3 months
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Potential clinical effect will be monitored by PET-MRI and SPECT scanning of the brain.
Time Frame: 3 months
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A total of 4 scanannings are performed during the study: 2 PET-MRI scans and 2 SPECT (Single-photon emission computed tomography) scans.
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Martin R Jensen, PhD, CytoVac A/S (Sponsor)
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CV003
- 2011-002180-22 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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