Locoregional Administration of Genetically Engineered Cells (EGFR/IL13Rα2 Pool-CAR T Cells) for the Treatment of Recurrent or Progressive High-Grade Gliomas

{ "EGFR/IL13Rα2 Pool-CAR T Cells for Recurrent High-Grade Gliomas", "This study is testing a new treatment called EGFR/IL13Rα2 pool-CAR T cells for people with high-grade gliomas that have come back or are getting worse. These CAR T cells are made from your own immune cells (T cells) that are specially changed in a lab to find and attack cancer cells. The treatment is given directly into the brain using a thin tube. The main goals are to find out how safe this treatment is and what the best dose is. Researchers will also look at how well the treatment controls the cancer and how long people live. This study is for adults aged 18 and older with specific types of recurrent astrocytoma or glioblastoma. The study plans to enroll 24 participants, but its current recruitment status is unclear.", "design": "This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 24 participants.", "commitments": "You would undergo a biopsy, blood, tumor cavity fluid, and cerebrospinal fluid collection, an echocardiography test, and an FDG-PET scan. You would also receive the EGFR/IL13Rα2 pool-CAR T-cells.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be monitored for adverse events for up to 15 years and for maximum tolerated dose for up to 5 years after treatment.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Locoregional Administration of Genetically Engineered Cells (EGFR/IL13Rα2 Pool-CAR T Cells) for the Treatment of Recurrent or Progressive High-Grade Gliomas

Recruiting

PHASE1Ages 18+InterventionalTreatment

City of Hope Medical Center

~24 participants

Updated 2026-08-12 on ClinicalTrials.gov

What's tested:Autologous Anti-EGFR/Anti-IL13Ralpha2 CAR T-cellsBiopsy ProcedureBiospecimen CollectionEchocardiography TestFDG-Positron Emission TomographyIntracranial Catheter Placement

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Incidence of adverse events

Measured over Up to 15 years

+1 more outcome measured

Conditions

Recurrent Astrocytoma, IDH-Mutant, Grade 4

Recurrent Glioblastoma, IDH-Wildtype

Where it's being run

1 sites across 1 states

California1

Study leadership

Behnam Badie · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Behnam Badie

[email protected]

626-218-7293

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Documented informed consent of the participant and/or legally authorized representative.

Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with Study PI approval.

Age 18 years and older.

KPS ≥ 70%, ECOG ≤ 2 (Appendix A).

Life expectancy ≥ 4 weeks.

Participant has a prior histologically confirmed diagnosis of a glioblastoma (IDH-wildtype) or grade 4 IDH-mutant astrocytoma, or has a prior histologically confirmed diagnosis of a grade 2 or 3 astrocytoma and now has radiographic progression consistent with grade 4 IDH-mutant astrocytoma.

Relapsed disease: radiographic evidence of recurrence/progression of measurable disease after standard therapy (such as temozolomide with or without Optune device), and ≥ 12 weeks after completion of front-line radiation therapy.

COH Clinical Pathology assessment at the initial tumor presentation or recurrent disease (reference Appendix B):

IL13Rα2+ expression by IHC \> 20, and

EGFR gene-altered by NGS or FISH analysis

No known contraindications to leukapheresis, steroids, imaging studies, or tocilizumab.

WBC \> 2000 /dl (or ANC ≥ 1,000/mm3)

Platelets ≥ 75,000/mm3

Hemoglobin \> 9g/dL

Total bilirubin ≤ 1.5x ULN

AST ≤ 2.5x ULN

ALT ≤ 2.5x ULN

Serum creatinine ≤1.6 mg/dL

O2 saturation ≥ 95% on room air.

Seronegative for HIV Ag/Ab combo, HCV, and active HBV

Women of childbearing potential (WOCBP): negative urine or serum pregnancy test.

Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of CAR T cells.

Exclusion

Owing to higher frequency of wound-related complications, participants who require active bevacizumab therapy at the time of enrollment are excluded.

Participant has not yet recovered from toxicities of prior therapy.

Participant has received any live vaccine within 30 days prior to enrollment.

Uncontrolled seizure activity and/or clinically evident progressive encephalopathy.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.

Clinically significant uncontrolled illness.

Active autoimmune disease requiring systemic immunosuppressive therapy

Active infection requiring IV antibiotics (for example, minor scalp infection is not exclusion).

Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection.

Other active malignancy.

Females only: Pregnant or breastfeeding.

Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures.

Prospective participants who, in the opinion of the Investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).

What this trial measures

Incidence of adverse eventsUp to 15 years
Toxicity will be assessed using the Common Terminology Criteria for Adverse Events version 5.0, Cytokine Release Syndrome/Neurotoxicity grading by the American Society for Transplantation and Cellular Therapy Consensus Criteria, Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome grading system, and Tumor Inflammation-Associated Neurotoxicity grading system.
Maximum tolerated dose (MTD)Up to 5 years
The MTD will be determined based on dose limiting toxicities (DLTs), toxicities observed in later cycles (5+), and the activity data. Rate and associated 90% Clopper and Pearson binomial confidence limits (90% confidence intervals \[CI\]) will be estimated for participants experiencing DLTs at the MTD schedule. Tables will be created to summarize all toxicities and side effects by dose, time post treatment, organ, severity, attributions, and arm.

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