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

Korábbi kezelés

• 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.
• Prior exposure to chimeric antigen receptor T cell therapy for treatment of glioblastoma.
• Previously implanted carmustine wafers or brachytherapy for the treatment of glioma.

Más betegség

• 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.
• Evidence of disseminated disease involving the brainstem, cerebellum or spinal cord.

Egyéb

• Subject is pregnant or lactating (Note: Breast milk cannot be stored for future use while the mother is being treated on study).
• Contraindication to MRI contrast agents or an inability to undergo MRI scans due to MRI non-compatible implanted materials.

• 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.