Phase I Study of Intraventricular Infusion of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors (CAR) in Subjects With Recurrent or Refractory Glioblastoma

Trial ID: NCT05366179

Interventional - Phase 1 - Recruiting

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.

Conditions

• Glioblastoma Multiforme

Interventions

• CAR.B7-H3T cells infusion

Eligibility

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.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Source: ClinicalTrials.gov

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