Recruiting
Phase 1

EGFR/IL13Rα2 Pool-CAR T Cells

Sponsor:

City of Hope Medical Center

Code:

NCT07544992

Conditions

Recurrent Astrocytoma, IDH-Mutant, Grade 4

Recurrent Glioblastoma, IDH-Wildtype

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Autologous Anti-EGFR/Anti-IL13Ralpha2 CAR T-cells

Biopsy Procedure

Biospecimen Collection

Echocardiography Test

FDG-Positron Emission Tomography

Study Details

Brief summary:

This phase I trial studies the side effects and best dose of EGFR/IL13Rα2 pool-chimeric antigen receptor (CAR) T cells when given through a thin, flexible tube into the brain (locoregional administration) in treating patients with high-grade gliomas that have come back after a period of improvement (recurrent) or that are growing, spreading, or getting worse (progressive). EGFR/IL13Rα2 pool-CAR T cells are a type of CAR T cell therapy. CAR T cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's tumor cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers.

Conditions

Recurrent Astrocytoma, IDH-Mutant, Grade 4

Recurrent Glioblastoma, IDH-Wildtype

Study ID

NCT07544992

Start date

May 26, 2026

Status verified date

Aug, 2026

Completion date

Nov 4, 2031

Anticipated

Primary completion date

Nov 4, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Main Inclusion Criteria

  • 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.

Main Exclusion Criteria

  • 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).

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (EGFR/IL13Rα2 pool-CAR T cell therapy)

Patients undergo leukapheresis followed by surgical resection, biopsy, and ICT and/or ICV catheter placement 1-3 weeks prior to cycle 1, day 0. Patients then receive EGFR/IL13Rα2 pool-CAR T cells via ICT and/or ICV catheter over 5 minutes on day 1 of each cycle. Cycles repeat every 7 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive additional cycles of EGFR/IL13Rα2 pool-CAR T cells per PI and patient discretion and/or undergo additional leukapheresis as needed on study. Patients also undergo ECHO during screening, as well as FDG-PET, MRI, and blood, TCF, and CSF sample collection throughout the study.

Interventions

Autologous Anti-EGFR/Anti-IL13Ralpha2 CAR T-cells

Given via ICT and/or ICV catheter

Biopsy Procedure

Undergo biopsy

Biospecimen Collection

Undergo blood, TCF, and CSF sample collection

Echocardiography Test

Undergo ECHO

FDG-Positron Emission Tomography

Undergo FDG-PET

Intracranial Catheter Placement

Undergo ICT and/or ICV catheter placement

Leukapheresis

Undergo leukapheresis

Magnetic Resonance Imaging

Undergo MRI

Resection

Undergo surgical resection

Primary outcome measure

  • Incidence of adverse events [ Time Frame: Up to 15 years ]
  • Maximum tolerated dose (MTD) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Behnam Badie

626-218-7293bbadie@coh.org

Principal Investigator:

Behnam Badie

More Information

Sponsor

City of Hope Medical Center

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-08-12.