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NCT01822652 · ClinicalTrials.gov registry record · Phase 1
3rd Generation GD-2 Chimeric Antigen Receptor and ICaspase Suicide Safety Switch, Neuroblastoma, GRAIN
A Phase 1 study of Neuroblastoma, sponsored by Baylor College of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 2
- Study locations
NCT01822652 is a Phase 1 study of Neuroblastoma that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 11 participants, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT01822652, a Phase 1 study of Neuroblastoma, is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 2
- Study locations
Study Summary
Subjects that have relapsed or refractory neuroblastoma are invited to take part in this gene transfer research study. We have found from previous research that we can put a new gene called a chimeric antigen receptor (CAR) into T cells that will make them recognize neuroblastoma cells and kill them. In a previous clinical trial, we used a CAR that recognizes GD2, a protein found on almost all neuroblastoma cells (GD2-CAR). We put this gene into T cells and gave them back to patients that had neuroblastoma. The infusions were safe and in patients with disease at the time of their infusion, the time to progression was longer if we could find GD2 T cells in their blood for more than 6 weeks. Because of this, we think that if T cells are able to last longer, they may have a better chance of killing neuroblastoma tumor cells. Therefore, in this study we will add new genes to the GD2 T cells that can cause the cells to live longer. These new genes are called CD28 and OX40. The purpose of this study will be to determine the highest dose of iC9-GD2-CD28-OX40 (iC9-GD2) T cells that can safely be given to patients with relapsed/refractory neuroblastoma. In other clinical studies using T cells, some investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. This is called lymphodepletion and we think that it will allow the T cells we infuse to expand and stay longer in the body, and potentially kill cancer cells more effectively. The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and fludarabine. Additionally, to effectively kill the tumor cells, it is important that the T cells are able to survive and expand in the tumor. Recent studies have shown that solid tumors release a substance (PD1) that can inhibit T cells after they arrive into the tumor tissue. In an attempt to overcome the effect of PD1 in neuroblastoma we
Conditions Studied
Interventions
- DRUG Cytoxan
- DRUG Fludara
- GENETIC iC9-GD2 T Cells - frozen
- GENETIC iC9-GD2 T Cells - fresh
- DRUG Keytruda
Study Locations (2)
Texas
- Houston Methodist Hospital - Houston
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2013-08 |
| Est. Completion | 2030-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01822652
The ClinicalTrials.gov registry entry for NCT01822652 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (95% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 5 interventions - of which Cytoxan is the first listed.
NCT01822652 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT01822652 about?
NCT01822652 is a clinical study titled "3rd Generation GD-2 Chimeric Antigen Receptor and ICaspase Suicide Safety Switch, Neuroblastoma, GRAIN". Subjects that have relapsed or refractory neuroblastoma are invited to take part in this gene transfer research study. We have found from previous research that we can put a new gene called a chimeric antigen receptor (CAR) into T cells that will make them recognize neuroblastoma cells and kill the...
What is the current status of trial NCT01822652?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2013-08. Estimated completion is 2030-10.
What conditions does trial NCT01822652 study?
This clinical trial studies the following conditions: Neuroblastoma.
What interventions are being tested in trial NCT01822652?
The interventions under investigation include: Cytoxan (DRUG), Fludara (DRUG), iC9-GD2 T Cells - frozen (GENETIC), iC9-GD2 T Cells - fresh (GENETIC), Keytruda (DRUG).
Who is sponsoring clinical trial NCT01822652?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01822652 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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