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NCT02070406 · ClinicalTrials.gov registry record · Phase 1
Gene-Modified T Cells, Vaccine Therapy, and Ipilimumab in Treating Patients With Locally Advanced or Metastatic Malignancies
A Phase 1 study, sponsored by Jonsson Comprehensive Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT02070406 is a Phase 1 study that was terminated before completion, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 4 participants.
The verdict
NCT02070406, a Phase 1 study, was terminated before completion, sponsored by Jonsson Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
This pilot phase I trial studies the side effects of taking ipilimumab after gene-modified T cells and vaccine therapy when treating patients with advanced cancer that has spread to other areas of the body and has not responded to standard therapies. This trial also will determine the best dose of Ipilimumab to use in this combination treatment. T cells are a special type of white blood cell (immune cell) that have the ability to kill cancer cells. T cells are taken from the blood and modified in the laboratory to recognize a specific protein expressed on cancer cells, called NY-ESO-1. This may allow the T cells to target and kill cancer cells that express that protein. Dendritic cells are another type of blood cell that can teach other cells in the body to look for cancer cells and attack them. Giving a dendritic cell vaccine with the NY-ESO-1 protein may help dendritic cells teach the immune system to target cancer cells expressing that protein, and further help the T cells attack cancer. Ipilimumab is a monoclonal antibody, a type of drug manufactured in the laboratory that is similar to antibodies made in the human body that fight off infection. Ipilimumab blocks a protein that turns down the immune system, so blocking this protein may make the immune system more active. This may increase the ability of immune cells to kill cancer cells and improve the effectiveness of the T cell transplant. Giving gene-modified T-cells, a dendritic cell vaccine, and ipilimumab together may teach the immune system to recognize and kill cancer cells that have the NY-ESO-1 protein.
Interventions
- DRUG cyclophosphamide
- DRUG fludarabine phosphate
- BIOLOGICAL aldesleukin
- BIOLOGICAL NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL
- BIOLOGICAL dendritic cell vaccine therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-07-17 |
| Est. Completion | 2018-12-18 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02070406
The ClinicalTrials.gov registry entry for NCT02070406 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jonsson Comprehensive Cancer Center, which has 321 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT02070406 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02070406 about?
NCT02070406 is a clinical study titled "Gene-Modified T Cells, Vaccine Therapy, and Ipilimumab in Treating Patients With Locally Advanced or Metastatic Malignancies". This pilot phase I trial studies the side effects of taking ipilimumab after gene-modified T cells and vaccine therapy when treating patients with advanced cancer that has spread to other areas of the body and has not responded to standard therapies. This trial also will determine the best dose of I...
What is the current status of trial NCT02070406?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2014-07-17. Estimated completion is 2018-12-18.
What interventions are being tested in trial NCT02070406?
The interventions under investigation include: cyclophosphamide (DRUG), fludarabine phosphate (DRUG), aldesleukin (BIOLOGICAL), NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL (BIOLOGICAL), dendritic cell vaccine therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT02070406?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
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