ClinicalTrials.gov record NCT06764537
Evaluation of in Vitro Antitumor Activity of GD2 CAR-T Cells in Glioblastoma
Evaluation of in Vitro Antitumor Activity of GD2 CAR-T Cells Generated From Blood of Glioblastoma Patients
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This laboratory (basic science) study evaluates how the glioblastoma tumor microenvironment influences the activity of anti‑GD2 CAR‑T cells in vitro. Each participant donates a single 40 mL blood sample; researchers generate CAR‑T cells and tumor‑environment cells from that blood and test them in the lab. This is not a treatment trial.
What it is studying. The study is testing how tumor‑environment cells from glioblastoma patients change the antitumor activity of anti‑GD2 CAR‑T cells in an in vitro glioblastoma model. Secondary questions include whether targeting tumor‑environment cells alters CAR‑T activity, how many and how functional the generated CAR‑T and environment cells are, and how well the cell isolation technique works.
What the researchers hope to learn. To improve understanding of resistance mechanisms in the glioblastoma microenvironment and to gather laboratory data that could inform strategies to enhance anti‑GD2 CAR‑T cell activity; to assess cell yield/quality and the efficiency of the isolation method.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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)
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Procedure
- Blood collection
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Give a single blood sample (40 mL) at an inclusion visit. The study team will use the blood to produce CAR‑T cells and tumor‑environment immune cells and run laboratory co‑culture experiments (measured about 14 days after the sample) to assess tumor cell killing, T‑cell proliferation, and cytokine release. Participants must complete eligibility checks and sign informed consent before the blood draw.
How the study is structured. Participants give one 40 mL blood sample. In the lab, investigators create anti‑GD2 CAR‑T cells and tumor‑environment cells from that sample and run co‑culture experiments. Key measurements at about 14 days include remaining tumor cells, percent of proliferating effector cells, and amounts of cytokines released. Single‑group, open (no masking) interventional laboratory study.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Glioblastoma. Does it apply to my diagnosis?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Gaucher disease
Important dates
- Study start
- January 2025 (estimated)
- Primary completion
- January 2027 (estimated)
- Study completion
- January 2027 (estimated)
- Target enrollment
- 18 participants (estimated)
- Last updated on registry
- Jan 8, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Central Hospital, Nancy, France
- Principal investigator
- REPPEL Loïc, Associate Professor
Central Hospital, Nancy, France
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Loïc REPPEL, PharmD, PhD 📞 +330383157938 ✉ l.reppel@chru-nancy.fr
Participating sites (1)
- Cell Therapy Unit, Nancy Hospital
Vandœuvre-lès-Nancy, 54500 · France
- Loïc REPPEL, PharmD, PhD · +330383157938 · l.reppel@chru-nancy.fr
Terms used on this page · explanations by MedicalUpdates.ai
- CAR-T cells
- A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
- immunosuppressive
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- corticosteroids
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- contraindication
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
← Back to clinical trials