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GPC-3 CAR T Cells for Recurrent Glioblastoma

This study is testing a new way to fight recurrent glioblastoma (a type of brain cancer) using your own immune cells. Researchers will collect your blood to create special GPC3-CAR T cells. These T cells are designed to find and kill cancer cells that have a specific marker called GPC3. You will receive a single dose of these GPC3-CAR T cells directly into the tumor area during a planned surgery. The main goal is to see how safe this treatment is by looking for any serious side effects in the first four weeks. To join, you must have GPC3-positive recurrent glioblastoma and be between 21 and 70 years old. The study plans to enroll 27 participants, but its current status is unclear.

Study design
This is an interventional study that will evaluate four different dosing schedules of GPC3-CAR T cells. It plans to enroll 27 participants.
What's involved
You will have blood collected to grow T cells. You will receive a single dose of GPC3-CAR T cells during a scheduled surgical resection, potentially with Tylenol and Benadryl beforehand. A small device called an Ommaya reservoir will also be placed during surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures dose-limiting toxicity at 4 weeks after treatment.

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NCT06815432

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

Recruiting
PHASE1Ages 21–70InterventionalTreatment
Baylor College of Medicine
~27 participants
Updated 2026-01-28 on ClinicalTrials.gov
What's tested:15.GPC3-CAR T cells

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Patients with Dose Limiting Toxicity
Measured over 4 weeks

Conditions

Glioblastoma Multiforme of Brain

Explore related trials

GlioblastomaGlypican-3

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Ganesh Rao, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Who to contact

Ganesh Rao, MD
[email protected]
(713) 798-4696
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of GPC3-positive recurrent glioblastoma with previous resection planned for repeat resection.
Age ≥18 years
Karnofsky score ≥60%
Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
GPC3 expression (as determined by immunohistochemistry) with an extent score of ≥ Grade 2 (\>25% positive tumor cells) and an intensity score of ≥ 2 (scale 0-4).
Age ≥ 18 years
Diagnosis of 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.

Exclusion

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
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)

What this trial measures

  • Number of Patients with Dose Limiting Toxicity4 weeks

    A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the 15.GPC3-CAR T cells. Specifically those which are Grade 5; hematologic dose-limiting toxicity is any Grade 4 non-hematologic toxicity that fails to return to Grade 2 within 72 hours; Grade 4 allergic reaction to CAR T cell administration; Grade 4 \\reactions due to CRS and neurotoxicity are rarely seen with the use of CAR-based immunotherapy. Grade 3 cytokine release syndrome (CRS) infusion reactions and neurologic toxicity will only be reported to the FDA if they fail to return to Grade 1 within 72 hours. Grade 4 CRS and neurologic toxicities will be reported to the FDA in an expedited fashion.