NCT02070406

Gene-Modified T Cells, Vaccine Therapy, and Ipilimumab in Treating Patients With Locally Advanced or Metastatic Malignancies

NY-ESO-1 TCR Engineered Adoptive Cell Transfer Therapy With CTLA4 Blockade
Jonsson Comprehensive Cancer Center·Phase 1·ClinicalTrials.gov·drugTerminated
View on ClinicalTrials.gov
Study focus
Drug/Device/Intervention
cyclophosphamide
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Jonsson Comprehensive Cancer Center
Location
Los Angeles, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Jul 17, 2014
End date
Dec 18, 2018
Enrollment
4 participants
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
Carcinoma in situ, unspecifiedMalignant neoplasm, without specification of siteMalignant neoplasm, primary site unspecifiedCarcinoma in situ of other and unspecified genital organsMalignant neoplasm: Connective and soft tissue, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT02070406
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.