cropped color_logo_with_background.png

Evaluation of in Vitro Antitumor Activity of GD2 CAR-T Cells in Glioblastoma

Study Purpose

Glioblastoma is a brain tumor with a very poor prognosis, affecting around 2,400 new patients every year. Current treatments do not provide good control of the disease. In view of the therapeutic impasse, it is necessary to develop new strategies. CAR-T cells (Chimeric antigen receptor T cells) represent a highly promising therapy for the treatment of incurable cancers, including glioblastoma. This treatment aims to destroy cancer cells by relying on the patient's own immune system. CAR-T cells are generated from the patient's own immune cells, more specifically T lymphocytes, which are genetically modified to express a tumor-specific receptor on their surface. CAR-T cells bind to tumor cells and cause their destruction. However, these cells have shown limited therapeutic power in the treatment of brain tumors. This is mainly due to the microenvironment surrounding the tumor, which is composed of immunosuppressive cells. These cells, and the molecules they secrete, help to reduce the activity of CAR-T cells that would otherwise reach the tumor. Little is currently known about these resistance mechanisms. The aim of this research is therefore to better understand these resistance mechanisms in order to propose a strategy for enhancing the therapeutic action of CAR-T cells in the treatment of glioblastoma. The main objective of this research is to evaluate the impact of the tumor environment on the antitumor efficacy of anti-GD2 CAR-T therapeutic cells in an in vitro glioblastoma model. Both tumor environment cells and CAR-T therapeutic cells will be generated from glioblastoma patient cells. The secondary objectives of this research are to.

  • - Evaluate the impact of tumor environment targeting on the in vitro antitumor efficacy of anti-GD2 CAR-T therapeutic cells.
  • - Evaluate the quality/quantity of generated cells (CAR-T cells and tumor environment cells) in relation to glioblastoma patients.
- Evaluate the efficiency of the cell isolation technique (CAR-T cells and tumor environment cells)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male or female, adult (age ≥ 18 years) - WHO 0 to 2.
  • - Patient with a diagnosis of histologically proven de novo glioblastoma with non-mutated IDH status according to WHO 2021 classification.
  • - Patient naïve to any treatment for this cancer.
  • - Patient weighing ≥ 50 kg.
  • - Patient able and willing to follow all study procedures in accordance with the protocol; - Person affiliated to a social security scheme or beneficiary of such a scheme.
  • - Person who has received full information on the organization of the clinical research and has signed an informed consent form.

Exclusion Criteria:

  • - People with hematological malignancies.
  • - People with a history of cancer < 5 years old.
  • - Immunocompromised (with immunodeficiency or current immunosuppressive therapy) - Chronic inflammatory disease.
  • - Person with current infection.
  • - Anyone taking corticosteroids >10mg/day on the day of blood sampling for research purposes.
  • - Anyone with a contraindication to blood sampling.
  • - Women of childbearing age without effective contraception.
  • - Persons covered by articles L.
1121-5, L. 1121-7 and L1121-8 of the French Public Health Code Pregnant, parturient or breast-feeding women Minor (not emancipated) Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice) Persons of full age who are unable to give their consent.
  • - Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care under articles L.
3212-1 and L. 3213-1

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06764537
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Central Hospital, Nancy, France
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Arms & Interventions

Arms

Experimental: Blood collection (40 mL) of glioblastoma patients

Interventions

Procedure: - Blood collection

Blood collection (40 mL) in glioblastoma patients

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Cell Therapy Unit, Nancy Hospital, Vandoeuvre-lès-Nancy, France

Status

Address

Cell Therapy Unit, Nancy Hospital

Vandoeuvre-lès-Nancy, , 54500

Site Contact

Loïc REPPEL, PharmD, PhD

[email protected]

+330383157938