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NCT04003649 · ClinicalTrials.gov registry record · Phase 1

IL13Ra2-CAR T Cells With or Without Nivolumab and Ipilimumab in Treating Patients With GBM

A Phase 1 study of Recurrent Glioblastoma and Refractory Glioblastoma, sponsored by City of Hope Medical Center.

Recruiting
Registry status
Phase 1
Development phase
60
Enrollment target
1
Study location

NCT04003649 is a Phase 1 study of Recurrent Glioblastoma and Refractory Glioblastoma that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 60 participants, below the 68-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (12% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04003649, a Phase 1 study of Recurrent Glioblastoma and Refractory Glioblastoma, is actively recruiting participants, sponsored by City of Hope Medical Center.

RECRUITING
Registry status
Phase 1
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

This phase I trial studies the side effects and how well IL13Ralpha2-CAR T cells work when given alone or together with nivolumab and ipilimumab in treating patients with glioblastoma that has come back (recurrent) or does not respond to treatment (refractory). Biological therapies, such as IL13Ralpha2-CAR T cells, use substances made from living organisms that may attack specific glioma cells and stop them from growing or kill them. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving IL13Ralpha2-CAR T cells and nivolumab together may work better in treating patients with glioblastoma.

Interventions

  • OTHER Quality-of-Life Assessment
  • OTHER Questionnaire Administration
  • BIOLOGICAL Nivolumab
  • BIOLOGICAL Ipilimumab
  • BIOLOGICAL IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells

Study Locations (1)

California

  • City of Hope Medical Center - Duarte

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2019-12-02
Est. Completion 2026-05-26
Phase Phase 1

Sponsor

City of Hope Medical Center

582 total trials

What the Registry Record Tells You About NCT04003649

The ClinicalTrials.gov registry entry for NCT04003649 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 68-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (12% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Recurrent Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.

NCT04003649 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT04003649 about?

NCT04003649 is a clinical study titled "IL13Ra2-CAR T Cells With or Without Nivolumab and Ipilimumab in Treating Patients With GBM". This phase I trial studies the side effects and how well IL13Ralpha2-CAR T cells work when given alone or together with nivolumab and ipilimumab in treating patients with glioblastoma that has come back (recurrent) or does not respond to treatment (refractory). Biological therapies, such as IL13Ralp...

What is the current status of trial NCT04003649?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2019-12-02. Estimated completion is 2026-05-26.

What conditions does trial NCT04003649 study?

This clinical trial studies the following conditions: Recurrent Glioblastoma, Refractory Glioblastoma.

What interventions are being tested in trial NCT04003649?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT04003649?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04003649 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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