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

Qualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

40 Participants
are grouped into 2 trial groups

Locations

This trial has no locations

Sponsors and collaborators