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Home»Lung cancer» Looking for patients with advanced squamous cell non-small-cell lung cancer or head and neck squamous cell carcinoma to test a new type of immunotherapy
Clinical Trial
Looking for patients with advanced squamous cell non-small-cell lung cancer or head and neck squamous cell carcinoma to test a new type of immunotherapy
This phase 1 trial is examining the safety and effectiveness of a new type of immunotherapy. The treatment involves genetically enhancing patients’ own immune cells to better fight advanced non-small-cell lung cancer (NSCLC) or head and neck cancer. The main outcome to be measured will be the highest safe dose of the treatment. This study is being conducted in Houston, Texas.
The details
One issue in cancer treatment is that treatments attack both cancer cells and healthy cells. The immune system generally attacks abnormal cells in the body. In cancer patients, the immune cells are no longer able to control the abnormal (cancer) cells. Immunotherapy boosts the body’s natural defenses to fight the cancer. IMA20 is a new type of treatment which extracts the patient’s own T cells (immune cells) and inserts a gene into the cells which will help them recognize and kill tumor cells. The genetically altered cells are then infused back into the body. As gene therapy is a new type of treatment, long term side effects are not known.
This trial will determine the highest safe dose of IMA20 and measure the long term side effects of the treatment. The main outcome will be measured by reporting any side effects for up to 15 years following treatment.
Who are they looking for?
This trial is recruiting 16 patients who need to be ineligible for other types of treatment including surgery and radiation. Both men and woman should be willing to use contraception during the treatment. Patients should also have adequate organ and marrow function, including kidney, heart, and lung function. In addition, a tumor accessible for biopsy will be necessary.
Patients will be excluded if they have any immunodeficiency, autoimmune disease or infection such as HIV, hepatitis B, hepatitis C, pneumonitis or gastrointestinal disorders. Patients should not have had prior organ or stem cell transplants. Participants should not have had severe immune related side effects from immune checkpoint inhibitors that required corticosteroids for longer than 12 weeks. Patients who have had chemotherapy, surgery or radiation within 3 weeks before the trial will not be eligible. Pregnant woman will be excluded as will patients with a history of other cancers in the last 3 years.
How will it work
Following initial screening for eligible patients, patients will have blood extracted and a tumor biopsy will be taken. The researchers will then isolate the T cells from the blood and use a virus to insert the new gene into the T cells. This gene will help the cells make a protein that recognizes specific tumor proteins.
Before the cells are infused back into the patient, the patient will be treated with chemotherapy. Two days after the last chemotherapy dose, the cells will be infused back into the patient. Four doses of IMA20 will be evaluated in the study. After infusion, the patient will be treated with a low dose of chemotherapy twice daily. The effectiveness of the treatment and any side effects will be recorded. Patients will then be monitored for up to 15 years after treatment.
