Advanced Solid Tumors - Healing Genes

Advanced Solid Tumors

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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

Phase 2


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


  1. Screening to confirm acceptance to the study.
  2. 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.
  3. Admission to the study center and a course of chemotherapy.
  4. 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.
  5. Vaccine administration to prompt anti-NY-ESO immune response days 1, 14, and 28.
  6. Receive aldesleukin Nivolumab administered: Treatment repeats every 2 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
  7. Follow up, including lab and imaging assessments, may continue for up to 15 years.

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)
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