Clinical trial · Observational
Optimizing Cytokine-Induced Killer Cells in Glioblastoma Patients
An In-depth Appraisal of Cytokine-induced Killer Cells in Glioblastomas Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cytokine-Induced Killer Cells | — | UNRESOLVED | — |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Patients affected by glioblastoma
- description
- Subject with a documented diagnosis of glioblastoma (WHO criteria 2021), as confirmed by reference histopathology at San Raffaele Hospital.
- label
- Healthy controls
- description
- Healthy donors will also be enrolled in the study to serve as controls in the manufacturing process and exploratory analysis. They will be recruited among healthy individuals attending our Unit
Primary outcomes (2)
- measure
- To optimize the manufacturing process to obtain CIK from patients affected by GBM.
- timeFrame
- From 3 to 5 weeks after enrollment
- description
- 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
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for the glioblastoma (GBM) cohort: * 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. Inclusion Criteria for the Healthy Volunteer Cohort: * Age ≥18 years. * Subject is willing and able to provide informed consent for participation in the study. * Subjects In good general health as evidenced by medical history Exclusion Criteria: * 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 * Documented autoimmune disease. * Documented positive serology for HIV or HBs antigen.
References
Publications (0)
Data not yet available