NCT06684899Not yet recruiting
Optimizing Cytokine-Induced Killer Cells in Glioblastoma Patients
An In-depth Appraisal of Cytokine-induced Killer Cells in Glioblastomas Patients
Source: ClinicalTrials.gov · Last updated 14 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 11 Nov 2024
- Start date
- Nov 2024
- Primary completion date
- Nov 2024
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Glioblastoma
- NCT number
- NCT06684899
What you commit to
- Study type: Observational
- Planned participants: 40
- From Nov 2024 to the primary completion date, Nov 2024
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of an acute infection requiring active treatment.
- Documented autoimmune disease.
- Documented positive serology for HIV or HBs antigen.
Lab values
- 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.
Other
- Subject is not willing or able to provide informed consent for participation in the study. - Pregnancy
- Documented immune deficiency
Who the study is looking for
- 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.
- Subject is willing and able to provide informed consent for participation in the study.
- Subjects In good general health as evidenced by medical history
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.