Genetically modified t cells take on glioblastoma
NCT ID NCT06815432
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 Hide 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)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Glioblastoma multiforme are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGHouston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug targets Sugar-Coated proteins on cancer cells
- Off-the-Shelf immune cells target solid tumors
- Can a modified herpes virus outsmart brain cancer?
- Could a parasite drug fight childhood brain tumors?
- Can mapping the Blood-Brain barrier in brain tumors unlock new clues?
- Can a pill that starves tumors of oxygen help fight advanced cancer?