GPC3-targeted CAR T cell therapy for recurrent GPC3-positive glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 interventional protocol collects a patient’s blood to grow and genetically modify their T cells with a GPC3-directed chimeric antigen receptor and IL-15 using a retroviral vector, then cryopreserves the product. When the participant returns for planned repeat tumor resection, the engineered cells are thawed and given via intracavitary administration at the resection site and an Ommaya reservoir is placed for access. The protocol is a single-dose administration with standard premedication (acetaminophen and diphenhydramine) and focuses primarily on safety and feasibility in GPC3-expressing recurrent glioblastoma. Eligibility requires immunohistochemical confirmation of GPC3 expression and adequate performance status.

Why it matters

Who can join: the full rules

Procurement Inclusion Criteria:

* Diagnosis of GPC3-positive recurrent glioblastoma with previous resection planned for repeat resection (as determined by immunohistochemistry).
* 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).
* Exhibits other risk factors of which administration of investigational agent is deemed not in the patient's best interest, in the opinion of the investigator

Treatment Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of GPC3-positive 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)

Where it's running

• Baylor St. Luke's Medical Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Ganesh Rao, MD — Baylor College of Medicine
• Study coordinator: Ganesh Rao, MD
• Email: grao@bcm.edu
• Phone: (713) 798-4696

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.