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Genetically modified t cells take on glioblastoma

NCT ID NCT06815432

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new type of immunotherapy for recurrent glioblastoma, an aggressive brain cancer. Researchers take a patient's own T cells and genetically engineer them to recognize and attack cancer cells that carry a protein called GPC3. The cells also include a safety switch that can be activated to stop them if needed. The study aims to find a safe dose and see if the treatment can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GPC3-CAR T cells with IL15 and iCasp9 safety switch
What this could lead to
If it works, this could point toward a new treatment option for recurrent glioblastoma, a brain cancer with few effective therapies.
What could go wrong
This is an early Phase 1 trial with only 27 participants, focused on safety. The treatment may not shrink tumors or improve survival, and there are risks of serious side effects like cytokine release syndrome.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 27 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2044

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Procurement Inclusion Criteria: * 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). 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 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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor St. Luke's Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

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