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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: Recruiting Phase 1 study of Recurrent Glioblastoma and Refractory Glioblastoma, sponsored by City of Hope Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will assess dose limiting toxicity and all toxicities. Toxicity is the primary endpoint and will be assessed using the National Cancer Institute (NCI)'s Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Rates and associated 95% Clopper and Pearson binomial confidence limits (95% confidence interval \[CI\]) will be estimated for participants' experiencing dose limiting toxicity (DLT) during neoadjuvant treatment period (DLT period 1), during adjuvant treatment period (DLT period
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-12-02 |
| Est. Completion | 2026-05-26 |
| Phase | Phase 1 |
What NCT04003649 shows while recruiting
NCT04003649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 68-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (12% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Recurrent Glioblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04003649's enrollment target sits among peer trials
60 19th of 62 higher than 43 of 62 other Recurrent Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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