Gene-Modified T Cells, Vaccine Therapy, and Ipilimumab in Treating Patients With Locally Advanced or Metastatic Malignancies - Trial NCT02070406
Access comprehensive clinical trial information for NCT02070406 through Pure Global AI's free database. This Phase 1 trial is sponsored by Jonsson Comprehensive Cancer Center and is currently Terminated. The study focuses on Unspecified Adult Solid Tumor, Protocol Specific. Target enrollment is 4 participants.
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Study Focus
Sponsor & Location
Jonsson Comprehensive Cancer Center
Timeline & Enrollment
Phase 1
Jul 17, 2014
Dec 18, 2018
Primary Outcome
Incidence of toxicity as defined using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0,Maximum tolerable dose (MTD) based on the number of subjects experiencing dose limiting toxicities (DLTs)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT02070406
Non-Device Trial