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Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma

NCT02208362 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-09-03

Study results available
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Summary

This phase I trial studies the side effects and best dose of genetically modified T-cell immunotherapy in treating patients with malignant glioma that has come back (recurrent) or has not responded to therapy (refractory). A T cell is a type of immune cell that can recognize and kill abnormal cells in the body. T cells are taken from the patient's blood and a modified gene is placed into them in the laboratory and this may help them recognize and kill glioma cells. Genetically modified T-cells may also help the body build an immune response against the tumor cells.

Conditions

  • Recurrent Glioblastoma
  • Recurrent Malignant Glioma
  • Recurrent WHO Grade II Glioma
  • Recurrent WHO Grade III Glioma
  • Refractory Glioblastoma
  • Refractory Malignant Glioma
  • Refractory WHO Grade II Glioma
  • Refractory WHO Grade III Glioma

Interventions

BIOLOGICAL

Arm 1: IL13Ra2-specific CAR Tcm cells

Given via intratumoral catheter

BIOLOGICAL

Arm 2: IL13Ra2-specific CAR Tcm cells

Given via intratumoral/intracavitary catheter

BIOLOGICAL

Arm 3: IL13Ra2-specific CAR Tcm cells

Given via intraventricular catheter

BIOLOGICAL

Arm 4: IL13Ra2-specific CAR Tcm cells

Given via intratumoral or intracavitary, and via intraventricular catheter

BIOLOGICAL

Arm 5: IL13Ra2-specific CAR Tn/mem cells

Given via intratumoral or intracavitary, and via intraventricular catheter

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Magnetic Resonance Imaging

Correlative studies

PROCEDURE

Magnetic Resonance Spectroscopic Imaging

Correlative studies

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Food and Drug Administration (FDA)

    collaborator FED

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Behnam Badie · City of Hope Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-18
Primary Completion
2021-02-08
Completion
2026-06-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02208362 on ClinicalTrials.gov