Optimizing Cytokine-Induced Killer Cells in Glioblastoma Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
The goal of this prospective observational cohort study is to assess the optimal in vitro production protocol for generating Cytokine-Induced Killer (CIK) cells, a type of T lymphocyte, and to evaluate the potential adverse effects of concurrent neuro-oncology therapies on these cells in glioblastoma (GBM) patients. Additionally, the study aims to explore mechanisms to enhance the antitumor activity of CIK cells against GBM by investigating GBM's immune escape mechanisms that may counteract the Human Leukocyte Antigen (HLA)-independent activity of CIK cells.
The main questions it aims to answer are:
What is the most effective in vitro production protocol for generating highly active CIK cells from GBM patients? Do concurrent chemoradiotherapy or steroid treatments interfere with the activation or efficacy of CIK cells? What are potential strategies to counteract GBM immune escape mechanisms against CIK cells? Researchers will compare CIK cells produced under different protocols, including the use of media supplemented with commercial blood derivatives, to identify the most effective protocol and evaluate the impact of concomitant therapies on CIK cell functionality.
Participants will:
Undergo a single peripheral blood collection (GBM patients and healthy controls).
Have mononuclear cells isolated from their blood samples and expanded in vitro as CIK cells using various production protocols.
Have their CIK cells tested in vitro to assess activation status and antitumor activity, identifying optimal production methods and potential strategies to overcome GBM immune escape.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥18 years.
Subject is willing and able to provide informed consent for participation in the study.
Subject with a documented diagnosis of GBM (WHO criteria 2021), as confirmed by reference histopathology at San Raffaele Hospital.
Age ≥18 years.
Disqualifiers
Subject is not willing or able to provide informed consent for participation in the study. - Pregnancy
Presence of an acute infection requiring active treatment.
Documented ematological abnormalities: leukocytes < 3,000/μl or lymphocytes < 500/μl or neutrophils < 1,000/μl or hemoglobin < 9 g/100 ml or thrombocytes < 100,000/μl, based on the most recent laboratory tests performed for clinical practice.
Documented immune deficiency
Trial population
We will screen the patients affected by glioblastoma, diagnosed at the San Raffaele Hospital according to the World Health Organization criteria 2021. Patients fulfilling the inclusion and exclusion criteria will be enrolled and a blood sample will be obtained in the window period between the diagnosis (biopsy or tumor debulking) and the start of the standard radio-chemotherapy regimen. Both male and female patients will be enrolled to obtain, if possible, equal representation in the analysis. Healthy donors will also be enrolled in the study to serve as controls in the manufacturing process and exploratory analysis.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 2 trial groupsGroup A: Patients affected by glioblastoma
Group B: Healthy controls
Trial outcomes
Primary outcomes
1
To optimize the manufacturing process to obtain CIK from patients affected by GBM.
Cytokine-induced killer cells will be expanded from patients affected by glioblastoma according to different protocols. A statistically significant higher expansion fold compared to the standard (serum-free) protocol will be considered the primary endpoint of Aim 1
Time frame
From 3 to 5 weeks after enrollment2
To establish the best applicability conditions of CIK in patients affected by GBM.
Cytokine-induced killer (CIK) cells will be treated with sequential doses of dexamethasone and temozolomide. The determination of the median toxic dose (TD50) will be considered as the endpoint to explore the concomitant use of these therapies.
Time frame
From 3 to 5 weeks after enrollmentLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: