Gene-Modified T Cells, Vaccine Therapy, and Nivolumab in Treating Patients With Stage IV or Locally Advanced Solid Tumors Expressing NY-ESO-1 (NYM)
NY-ESO-1 TCR Engineered Adoptive Cell Transfer Therapy With Nivolumab PD-1 Blockade
UCLA / Jonsson Comprehensive Cancer Center researchers need patients with Stage IV or locally advanced solid tumors that test positive for NY-ESO-1 antigen, to trial a new triplicate therapy involving
- An autologous (to the self) immune T-cell transplant after the immune cells have been gene modified to attack NY-ESO-1-positive tumor cells
- A dendritic cell vaccine of the NY-ESO-1 protein that may help dendritic cells teach the immune system to target cancer cells expressing that protein, and further help the T cells attack cancer
- Nivolumab which may teach the immune system to recognize and kill cancer cells that express NY-ESO-1
The treatment will require leukapheresis to collect the T-cells for gene modification, chemotherapy before they are re-infused, and proleukin drugs to help the cells grow. Follow up, including lab and imaging assessments, may continue for up to 15 years.
- Be 16 years of age or older
- Have Stage IV or locally advanced cancers for which no alternative therapies with proven survival advantage are available
- Not have bone marrow involvement based on CT or PET scan at screening
THE STUDY INVOLVES:
- Screening to confirm acceptance to the study.
- Leukapheresis to collect the patient’s own stem cells, which will be gene-modified in the lab (no treatment during that period) to target cancer cells.
- Admission to the study center and a course of chemotherapy.
- Infusion of the gene-modified stem cells, followed by aldesleukin/proleukin to promote their growth for 7 days beginning on day 1 for a maximum of 14 doses.
- Vaccine administration to prompt anti-NY-ESO immune response days 1, 14, and 28.
- Receive aldesleukin Nivolumab administered: Treatment repeats every 2 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- Follow up, including lab and imaging assessments, may continue for up to 15 years.
LOCATIONS & CONTACTS:
Trials will take place at the University of California at Los Angeles (UCLA). Map.
Siwen Hu-Lieskovan | 310-794-4955
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Or go online: