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Advanced Malignancies - Healing Genes
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Advanced Malignancies

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Gene and Vaccine Therapy in Treating Patients With Advanced Malignancies

Adoptive Transfer of NY-ESO-1 TCR Engineered Peripheral Blood Mononuclear Cells (PBMC) After a Nonmyeloablative Conditioning Regimen, With Administration of NY-ESO-1157-165 Pulsed Dendritic Cells and Interleukin-2, in Patients With Advanced Malignancies


Phase 2

DESCRIPTION:

Doctors at the University of California at Los Angeles (UCLA ), seek patients with severe advanced cancers that test positive for NY-ESO-1 antigen to trial a therapeutic gene therapy and vaccine combination. This therapy utilizes the patient’s own (autologous) stem cells, drawn from bone marrow and blood, which will be gene-modified in the lab to impart a gene for the NY-ESO-1 immune receptor, which will then recognize the cancer cells. After chemotherapy to reduce the existing immune system, these modified cells are re-infused to replace the immune system with new cells that have been taught to attack and kill the cancer cells and thereby improve immune system anti-tumor function.. Additionally, a vaccine made from NY-ESO proteins will be provided to mobilize the immune system against the tumor cells.

Follow up assesses the tumor’s response for 90 days and up to 6 years, and includes blood samples and PET scans at 40 days.


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
  • Life expectancy of > 3 months

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 to promote their growth. This period may last up to 14 days.
  5. Vaccine administration to prompt anti-NY-ESO immune response.
  6. Follow up to assess clinical response for 90 days and up to 6 years, and includes blood samples and PET scans at 40 days.
  7. After day 90, 3 additional doses of vaccine may be given.

LOCATIONS & CONTACTS:
Trials will take place at the University of California at Los Angeles (UCLA). Map.
 
Contact:
Arun Singh  |  310-829-5471  |  [email protected]
 
SPONSORS
Jonsson Comprehensive Cancer Center
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT01697527

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