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Advanced Solid Tumors - Healing Genes
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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

DESCRIPTION:

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.


PATIENT MUST:

  • 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:

  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.

LOCATIONS & CONTACTS:
Trials will take place at the University of California at Los Angeles (UCLA). Map.

Contact:
Siwen Hu-Lieskovan   |   310-794-4955
 
SPONSORS
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT02775292

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