Recruiting
Phase 1

GO-CART T Cells

Sponsor:

Baylor College of Medicine

Code:

NCT06815432

Conditions

Glioblastoma Multiforme of Brain

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Interventions

15.GPC3-CAR T cells

Study Details

Brief 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.

Conditions

Glioblastoma Multiforme of Brain

Study ID

NCT06815432

Start date

Oct 10, 2025

Status verified date

Sep, 2026

Completion date

Dec 3, 2044

Anticipated

Primary completion date

Dec 5, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

27 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 15.GPC3-CAR T cells

GPC3-CAR and IL15 will be administered to patients with GPC3-positive glioblastoma.

Interventions

15.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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ganesh Rao, MD

(713) 798-4696grao@bcm.edu

Ramy Sweidan

(832) 824-4723Ramy.Sweidan@bcm.edu

Locations

Baylor St. Luke's Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ganesh Rao, MD

(713) 798-4696grao@bcm.edu

More Information

Sponsor

Baylor College of Medicine

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Keywords

  • GPC3-positive tumors
  • GPC3-CAR T cells
  • Glioblastoma
  • Brain Tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.