Brain cancer breakthrough? new CAR T-Cell trial hopes to tame glioblastoma
NCT ID NCT05366179
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests whether a new type of immune cell therapy (CAR T-cells) is safe for people with glioblastoma, a fast-growing brain cancer that has come back or not responded to standard treatment. The therapy is given directly into the fluid around the brain. The main goal is to check for side effects, not to cure the disease. About 36 adults will take part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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May 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
INCLUSION CRITERIA 1. Karnofsky score of \> 60% 2. Diagnosis or recurrent supratentorial- or infra-tentorial glioblastoma multiforme (GBM) (World Health Organization 2016 or 2021) based on Response assessment in neuro-oncology criteria (RANO) magnetic resonance imaging (MRI) criteria. Disseminated GBM down the spinal cord is not allowed. Must have previously undergone resection or biopsy at initial diagnosis. 3. Must have undergone at least 4005 cGy of radiation with concurrent temozolomide. 4. No current or previous exposure to antiangiogenic agents, such as bevacizumab. 5. Female subjects of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after study treatment discontinuation. 6. Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception starting with the first dose of study therapy through 3 months after the cell infusion therapy. If a male subject receives multiple infusions, they must remain on contraception throughout the duration and 3 months after the last cell infusion therapy. 7. The subject is willing and able to comply with study procedures based on the judgment of the investigator. EXCLUSION CRITERIA 1. Subject is pregnant or lactating (Note: Breast milk cannot be stored for future use while the mother is being treated on study). 2. Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen. 3. Active infection with HIV, hepatitis B virus, hepatitis C virus (HCV). Note: To meet eligibility subjects are required to be negative for HIV antibody, negative for HTLV1 and 2 antibodies, negative for Hepatitis B surface antigen, and negative for HCV antibody and viral load. 4. Contraindication to MRI contrast agents or an inability to undergo MRI scans due to MRI non-compatible implanted materials. 5. Prior exposure to chimeric antigen receptor T cell therapy for treatment of glioblastoma. 6. Evidence of disseminated disease involving the brainstem, cerebellum or spinal cord. 7. Previously implanted carmustine wafers or brachytherapy for the treatment of glioma.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Lineberger Comprehensive Cancer Center
RECRUITINGChapel Hill, North Carolina, 27599, United States
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