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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints: details revised at 2 of 2 entries Study description expanded, about 12 words · Site details revised · Collaborators: details revised at 1 of 2 entries · 1 more Show 4 more changesShow less
    • Study description expanded, about 12 words
    • Site details revised
    • Collaborators: details revised at 1 of 2 entries
    • Eligibility criteria shortened, about 4 words
  2. Re-verified, no change to tracked fieldsv5
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 3, 2025 to Oct 10, 2025 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Dec 3, 2025 to Oct 10, 2025
    • Site details revised
  4. Primary completion date: Jun 5, 2029 to Dec 5, 2029 Start date: Jul 3, 2025 to Dec 3, 2025 · Completion date: Jun 3, 2044 to Dec 3, 2044v3 Show 2 more changesShow less
    • Start date: Jul 3, 2025 to Dec 3, 2025
    • Completion date: Jun 3, 2044 to Dec 3, 2044
  5. Start date: Apr 3, 2025 to Jul 3, 2025 Primary completion date: Apr 5, 2029 to Jun 5, 2029 · Completion date: Apr 3, 2044 to Jun 3, 2044 · Eligibility criteria expanded, about 33 wordsv2 Show 3 more changesShow less
    • Primary completion date: Apr 5, 2029 to Jun 5, 2029
    • Completion date: Apr 3, 2044 to Jun 3, 2044
    • Eligibility criteria expanded, about 33 words

    See this version in full on ClinicalTrials.gov ↗

  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06815432
Lead Sponsor Baylor College of Medicine
Collaborators: Center for Cell and Gene Therapy, Baylor College of Medicine, Baylor St. Luke's Medical Center
Conditions Glioblastoma Multiforme of Brain
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov