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

Central Hospital, Nancy, France

Status

Not yet enrolling

Conditions

Glioblastoma

Treatments

Procedure: Blood collection

Study type

Interventional

Funder types

Other

Identifiers

NCT06764537

RIPH2: 2024-A02098-39 2022PI15

Details and patient eligibility

About

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)

Enrollment

18 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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