RecruitingPhase 1NCT06815432

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

GPC-3 Chimeric Antigen Receptor T Cells FOR Recurrent GPC-3 Positive Glioblastoma


Sponsor

Baylor College of Medicine

Enrollment

27 participants

Start Date

Oct 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 21 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR T-cell therapy — immune cells that have been genetically engineered to recognize and attack a protein called GPC-3 found on glioblastoma brain tumors. The treatment is being studied in people whose glioblastoma has come back after prior surgery and treatment. The engineered cells are delivered directly into the brain during repeat surgery. **You may be eligible if...** - You are 18 or older with recurrent glioblastoma - Your tumor has been confirmed to strongly express GPC-3 (by a biopsy test) - You are scheduled for a repeat brain surgery - Your general health and physical function are adequate (Karnofsky score of 60% or higher) **You may NOT be eligible if...** - You have had an organ transplant - You are HIV-positive - You have an active serious infection - You have previously had a severe allergic reaction to mouse-derived proteins Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETIC15.GPC3-CAR T cells

Four different dosing schedules will be evaluated. The following dose levels will be evaluated: DL1: 5x10\^6 DL2: 1x10\^7 DL3: 5x10\^7 DL4: 1x10\^8


Locations(1)

Baylor St. Luke's Medical Center

Houston, Texas, United States

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NCT06815432


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