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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNC Lineberger Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • CAR.B7-H3T cells infusion

Treatment groups

36 Participants
are divided into 1 treatment group