Who is eligible for clinical trial NCT05366179?

Participants must meet protocol criteria for Glioblastoma Multiforme. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05366179 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-16

Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc (NCT05366179)

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: UNC Lineberger Comprehensive Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to test the safety of using T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (CAR.B7-H3T cells) in patients with glioblastoma. CAR.B7-H3T cells treatment has not been tested in humans and is not an approved treatment by the Food and Drug Administration for glioblastoma.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (8 items).

Location: Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Karnofsky score of \> 60%
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.
Must have undergone at least 4005 cGy of radiation with concurrent temozolomide.
No current or previous exposure to antiangiogenic agents, such as bevacizumab.
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.
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.
The subject is willing and able to comply with study procedures based on the judgment of the investigator.

Usually NOT eligible if any of the following apply:

EXCLUSION CRITERIA
Subject is pregnant or lactating (Note: Breast milk cannot be stored for future use while the mother is being treated on study).
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.
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.
Contraindication to MRI contrast agents or an inability to undergo MRI scans due to MRI non-compatible implanted materials.
Prior exposure to chimeric antigen receptor T cell therapy for treatment of glioblastoma.
Evidence of disseminated disease involving the brainstem, cerebellum or spinal cord.
Previously implanted carmustine wafers or brachytherapy for the treatment of glioma.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗