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Advanced Cancer - Healing Genes
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Advanced Cancer

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Genetically Engineered PBMC and PBSC Expressing NY-ESO-1 TCR After a Myeloablative Conditioning Regimen to Treat Patients With Advanced Cancer (NYESO SCT)

Adoptive Transfer of NY-ESO-1 TCR Engineered Peripheral Blood Mononuclear Cells (PBMC) and Peripheral Blood Stem Cells (PBSC) After a Myeloablative Conditioning Regimen, With Administration of Interleukin-2, in Patients With Advanced Malignancies


Phase 1

DESCRIPTION:
Doctors at the University of California in Los Angeles seek patients with severe advanced cancers to trial a therapeutic gene therapy. 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 targets cancer cells. After chemotherapy to reduce the existing immune system, these modified cells are re-infused, intended to replace the immune system with new immune cells that have been redirected to attack and kill the cancer cells and thereby improve immune system function against cancer.

Follow up includes blood collection for safety and immune monitoring on days 0, 1, 3, 5, 7, 14, 30, 60, 90, and 120, and also undergo PET scan/computed tomography (CT) on days 25 and 120. After completion of study treatment, patients are followed up every 2-3 months for 2 years, every 6 months for 5 years, and annually for 15 years.


PATIENT MUST:

  • Be 16 years of age or older
  • Have confirmed diagnosis of Stage IV or locally advanced unresectable cancers for which no alternative therapies are available
  • Meet lab criteria to confirm their cancer expresses the antigen to which the study plans to gene-modify cells to recognize

THE STUDY INVOLVES:

  1. Screening to confirm acceptance to the study.
  2. Drugs to stimulate the release of stem cells from the bone marrow into the blood.
  3. Blood draw to recover the patient’s own stem cells, which will be gene-modified in the lab (no treatment during that period).
  4. Admission to the study center and a course of chemotherapy.
  5. Infusion of the gene-modified stem and bone marrow cells over 2 days, followed by aldesleukin to promote their growth for 7 days.
  6. Blood collection for safety and immune monitoring on days 0, 1, 3, 5, 7, 14, 30, 60, 90, and 120. PET scan/CT with a tracer to illuminate the tumor on days 25 and 120.

LOCATIONS & CONTACTS:
The trial will take place at the UCLA / Jonsson Comprehensive Cancer Center in Los Angeles, CA. Map.

Contact:
Theodore Scott Nowicki, M.D., PhD  |  310-206-2090  |  [email protected]
Antonio Ribas, M.D.  |  310-206-3928  |  [email protected]
 
SPONSORS
Jonsson Comprehensive Cancer Center
California Institute for Regenerative Medicine (CIRM)
National Cancer Institute (NCI)
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT03240861

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