GPC-3 CAR T CELLS for Recurrent GPC-3 Positive Glioblastoma

Launched by BAYLOR COLLEGE OF MEDICINE · Feb 4, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients with recurrent glioblastoma, a type of brain cancer that expresses a specific protein called GPC3. The researchers are exploring a novel approach that combines special immune cells called T cells with a gene that helps them better recognize and attack tumor cells. These T cells are engineered to carry a special receptor known as GPC3-CAR, along with another gene (IL15) that helps them grow and stay active in the bloodstream longer. The goal is to see if this combination can effectively kill tumor cells in patients whose tumors are positive for GPC3.

To participate in this trial, individuals must be at least 18 years old and have a diagnosis of recurrent glioblastoma that has been previously treated. They should also have a certain level of physical function and stable health. Participants can expect to receive the modified T cells and will be monitored closely for any side effects. It’s important to note that this treatment is still in the experimental stage and has not yet been approved for general use. If necessary, a specific drug will be available to safely remove the T cells if they cause unwanted side effects.

Gender

ALL

Eligibility criteria

• Procurement Inclusion Criteria:
• • 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 \[scale 0-4\]).
• • Age ≥18 years
• • Karnofsky score ≥60%
• • Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
• Procurement Exclusion Criteria:
• • 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).
• • History of organ transplantation
• • Known HIV positivity
• • Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections).
• Treatment Inclusion Criteria:
• • Age ≥ 18 years
• • Diagnosis of recurrent glioblastoma with previous resection
• • Karnofsky score ≥ 60%-
• • Stable neurologic exam for 7 days prior to enrollment
• • 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)
• * Adequate organ function:
• • Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml/min
• • total bilirubin \< 3 times ULN for age
• • INR ≤1.7
• • absolute neutrophil count \> 500/μl
• • platelet count \> 100,000/μl (can be transfused but must be achieved prior to enrollment)
• • Hgb ≥ 7.0 g/dl (can be transfused)
• • Pulse oximetry \>90% on room air
• • Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study
• • Sexually active patients must be willing to utilize one of the more effective birth control methods for 3 months after the T-cell infusion.
• • Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
• Treatment Exclusion Criteria:
• • Pregnancy or lactation
• • Uncontrolled infection
• • Known HIV positivity
• • Active bacterial, fungal or viral infection
• • History of organ transplantation
• • 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)