Intracavitary Administration of 15.GPC3-CAR T Cells for the Treatment of Patients with GPC3-Positive Recurrent Glioblastoma who are Undergoing Repeat Resection, GO-CART Trial

Inclusion Criteria

• PROCUREMENT: GPC3-positive recurrent GBM with previous resection (as determined by immunohistochemistry with an extent score of >= grade 2 [> 25% positive tumor cells] and an intensity score of >= 2 [scale 0-4]) who are planned for further resection * GPC3 expression will be evaluated by standard immunohistochemistry (IHC) at Baylor College of Medicine, Department of Pathology for all patients to meet procurement eligibility. All patients will send at least 5 unstained slides
• PROCUREMENT: Age ≥ 18 years
• PROCUREMENT: Karnofsky score ≥ 60%
• PROCUREMENT: Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
• TREATMENT: Diagnosis of GPC3-positive recurrent glioblastoma with previous resection planned for repeat resection
• TREATMENT: Age ≥ 18 years
• TREATMENT: Diagnosis of recurrent glioblastoma with previous resection and plans for repeat resection
• TREATMENT: Karnofsky score ≥ 60%
• TREATMENT: Stable neurologic exam for 7 days prior to enrollment
• TREATMENT: Stable or decreasing dose of steroids over past 7 days prior to surgery and administration of therapy (max allowable dose is 0.1mg/kg dexamethasone or equivalent per day)
• TREATMENT: Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml/min
• TREATMENT: Total bilirubin < 3 times upper limit of normal (ULN) for age
• TREATMENT: International normalized ratio (INR) ≤ 1.7
• TREATMENT: Absolute neutrophil count > 500/µl
• TREATMENT: Platelet count > 100,000/µl (can be transfused but must be achieved prior to enrollment)
• TREATMENT: Hemoglobin (Hgb) ≥ 7.0 g/dl (can be transfused)
• TREATMENT: Pulse oximetry > 90% on room air
• TREATMENT: Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study
• TREATMENT: Sexually active patients must be willing to utilize one of the more effective birth control methods for 3 months after the T-cell infusion
• TREATMENT: Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent

Exclusion Criteria

• PROCUREMENT: History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)
• PROCUREMENT: History of organ transplantation
• PROCUREMENT: Known HIV positivity
• PROCUREMENT: Active bacterial, fungal or viral infection (except hepatitis B or hepatitis C virus infections)
• TREATMENT: Pregnancy or lactation
• TREATMENT: Uncontrolled infection
• TREATMENT: Known HIV positivity
• TREATMENT: Active bacterial, fungal or viral infection
• TREATMENT: History of organ transplantation
• TREATMENT: History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)