GlioblastomaBOOSTCARNCT06764537
Evaluation of in Vitro Antitumor Activity of GD2 CAR-T Cells in Glioblastoma
A study testing Blood collection in people with Glioblastoma, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Blood collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Cell Therapy Unit, Nancy Hospital
Vandœuvre-lès-Nancy, 54500
Loïc REPPEL, PharmD, PhD, +330383157938, l.reppel@chru-nancy.fr
About this study
Official title: Evaluation of in Vitro Antitumor Activity of GD2 CAR-T Cells Generated From Blood of Glioblastoma Patients
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.
Read more
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)
- Conditions
- Glioblastoma
- Being tested
- Blood collection
- Keywords
- Glioblastoma, GD2 CAR-T cells, Myeloid-derived suppressor cells, microenvironment
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionProcedure or surgery
Blood collection (40 mL) in glioblastoma patients
| Study group | Role | What they receive |
|---|---|---|
| Blood collection (40 mL) of glioblastoma patients | Experimental | Not described Receives: Procedure: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of the number of residual tumor cells after in vitro co-culture in presence of CAR-T and MDSC cells
Using in vitro cytotoxicity tests
Measured: 14 days after the blood sample realized at the inclusion visit
The percentage of proliferative effector cells
Using flow cytometry
Measured: 14 days after the blood sample realized at the inclusion visit
The quantity of cytokines released
Using ELISA tests
Measured: 14 days after the blood sample realized at the inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, REPPEL Loïc, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764537
- Sponsor's protocol ID
- RIPH2: 2024-A02098-39 2022PI15
- Acronym
- BOOSTCAR
- Status last verified
- Jan 2025
- First submitted
- 28 Nov 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of in Vitro Antitumor Activity of GD2 CAR-T Cells Generated From Blood of Glioblastoma Patients
- ClinicalTrials.gov ID
- NCT06764537
- Acronym / sponsor ID
- BOOSTCAR / RIPH2: 2024-A02098-39 2022PI15
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, GD2 CAR-T cells, Myeloid-derived suppressor cells, microenvironment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood collection (40 mL) of glioblastoma patients | Experimental | Procedure: Blood collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionBlood collection (40 mL) in glioblastoma patients | Procedure or surgery | Blood collection (40 mL) of glioblastoma patients |
Primary outcome
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
The percentage of proliferative effector cells
Time frame: 14 days after the blood sample realized at the inclusion visit
Using flow cytometry
The quantity of cytokines released
Time frame: 14 days after the blood sample realized at the inclusion visit
Using ELISA tests
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood collection in people with Glioblastoma, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Loïc REPPEL, PharmD, PhD (+330383157938, l.reppel@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.