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

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT06815432
Phase
PHASE1
Status
Recruiting
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Conditions

  • Glioblastoma Multiforme of Brain

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 15.GPC3-CAR T cells — GENETIC
    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

Study Details

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.

Key Dates

Start date
Oct 10, 2025
Status verified
Jan 2025
Primary completion
Dec 5, 2029
Completion
Dec 3, 2044

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 15.GPC3-CAR T cells
    GPC3-CAR and IL15 will be administered to patients with GPC3-positive glioblastoma.

Primary Outcome Measure

Number of Patients with Dose Limiting Toxicity [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor St. Luke's Medical CenterHoustonTexas77030
Ganesh Rao, MD
[email protected]
(713) 798-4696

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By research site
Baylor St. Luke's Medical Center· Houston, TX

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