Actively Recruiting
GPC-3 CAR T CELLS FOR Recurrent GPC-3 Positive Glioblastoma
Led by Baylor College of Medicine · Updated on 2026-01-28
27
Participants Needed
1
Research Sites
999 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
C
Center for Cell and Gene Therapy, Baylor College of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T-cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat participants with cancers. They have shown promise, but have not been strong enough to cure most participants. The study team has found from previous research that we can put a new gene (a tiny part of what makes-up DNA and carries the participants traits) into T cells that will make them recognize cancer cells and kill them. In the lab, the study team has made several genes called a chimeric antigen receptor (CAR), from an antibody called GC33. The antibody GC33 recognizes a protein found on the participants brain tumor. This CAR is called GPC3-CAR. To make this CAR more effective, the study has also added a gene that includes IL15. IL15 is a protein that helps CAR T cells grow better and stay in the blood longer so that they may kill tumors better. The mixture of GPC3-CAR and IL15 killed tumor cells better in the laboratory when compared with CAR T cells that did not have IL15. This study will test T cells with the IL15 GPC3-CAR (GO-CART T cells) in participants with GPC3-positive brain tumors. T cells made to carry a gene called iCasp9 can be killed when they encounter a specific drug called AP1903. The study team will insert the iCasp9 and IL15 together into the T cells using a virus that has been made for this study. The drug (AP1903) is an experimental drug that has been tested in humans with no bad side-effects. The study team will use this drug to kill the T cells if necessary due to side effects. This study will test T cells genetically engineered with a GPC3-CAR and IL15 (GO-CART T cells) in participants with GPC3-positive brain tumors. The GO-CART T cells are an investigational product not approved by the Food and Drug Administration.
CONDITIONS
Official Title
GPC-3 CAR T CELLS FOR Recurrent GPC-3 Positive Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of GPC3-positive recurrent glioblastoma with planned repeat surgical resection
- Age 18 years or older
- Karnofsky performance score of 60% or higher
- Informed consent explained, understood, and signed by patient or guardian
- GPC3 expression determined by immunohistochemistry with extent score of at least Grade 2 (>25% positive tumor cells) and intensity score of at least 2 (scale 0-4)
- Stable neurologic exam for 7 days before enrollment
- Stable or decreasing steroid dose over past 7 days before surgery (max 0.1 mg/kg dexamethasone or equivalent per day)
- Adequate organ function (creatinine clearance ≥ 60 ml/min, total bilirubin < 3 times upper limit of normal, INR ≤ 1.7, absolute neutrophil count > 500/µl, platelet count > 100,000/µl, hemoglobin ≥ 7.0 g/dl)
- Pulse oximetry > 90% on room air
- Recovered from acute toxic effects of prior chemotherapy or investigational agents
- Sexually active patients willing to use effective birth control for 3 months after infusion
- Patient or guardian has given informed consent
You will not qualify if you...
- History of hypersensitivity to murine protein-containing products or presence of human anti-mouse antibody prior to enrollment (for patients previously treated with murine antibodies)
- History of organ transplantation
- Known HIV infection
- Active bacterial, fungal, or viral infection (except Hepatitis B or C)
- Pregnancy or lactation
- Other risk factors making investigational agent use unsafe as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Baylor St. Luke's Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
G
Ganesh Rao, MD
CONTACT
R
Ramy Sweidan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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