T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Cancer
Phase II Study of Metastatic Cancer That Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Anti-NY ESO-1 Murine TCR-Gene Engineered Lymphocytes
Doctors at the National Institutes of Health Clinical Center in Bethesda, MD, seek patients with severe advanced cancers that express NY-ESO-1 antigen 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 that 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 6 and 12 weeks after cell infusion, then 3x every 3 months, then twice every 6 months.
- Be 15 to 70 years of age
- Have confirmation of diagnosis of metastatic cancer including melanoma by the NCI Laboratory of Pathology
- Meet lab criteria to confirm their cancer expresses the antigen to which the study plans to gene-modify cells to recognize
THE STUDY INVOLVES:
- Screening to confirm acceptance to the study.
- Blood draw to recover 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 and bone marrow cells over 2 days, followed by aldesleukin to promote their growth for 7 days.
- Blood collection for safety and immune monitoring 6 and 12 weeks after cell infusion, then 3x every 3 months, then twice every 6 months.
LOCATIONS & CONTACTS:
Trials will take place at the National Institutes of Health Clinical Center in Bethesda, MD. Map.