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NCT Number: NCT06764537

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

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)

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cell Therapy Unit, Nancy Hospital

Vandœuvre-lès-Nancy, 54500, France

Location contact

Loïc REPPEL, PharmD, PhD

CONTACT

[email protected]

+330383157938

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Collection

Procedure

Blood collection (40 mL) in glioblastoma patients

Primary outcomes

  1. Quantification of the number of residual tumor cells after in vitro co-culture in presence of CAR-T and MDSC cells

    Time frame: 14 days after the blood sample realized at the inclusion visit

    Using in vitro cytotoxicity tests

  2. The percentage of proliferative effector cells

    Time frame: 14 days after the blood sample realized at the inclusion visit

    Using flow cytometry

  3. The quantity of cytokines released

    Time frame: 14 days after the blood sample realized at the inclusion visit

    Using ELISA tests

Study contacts

Contact information is provided by the study sponsor or research team.

Loïc REPPEL, PharmD, PhD

CONTACT

[email protected]

+330383157938

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Evaluation of in Vitro Antitumor Activity of GD2 CAR-T Cells Generated From Blood of Glioblastoma Patients

Acronym: BOOSTCAR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2025
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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