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A Phase I Clinical Trial of Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin (NCT02414269)

Summary

To take part in this study you must have metastatic (stage IV) breast cancer that has spread to the pleura.

This study is investigating the safety and effect (good or bad) of using a new type of CAR-T immunotherapy. CAR-T is a personalized immunotherapy made from a patient's white blood cells. The blood cells are removed from the patient and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. The cells are then infused back into the patient in the hospital. The pleura is the thin layer of tissue that covers the lungs and lines the interior wall of the chest cavity. This CAR-T therapy is designed to target proteins found on cancer cells in the pleura. The CAR-T therapy is given along with acetaminophen and diphenhydramine. These drugs are used to prevent infusion-related reactions.

Phase I Study of Adoptive Immunotherapy for Advanced ROR1+ Malignancies With Defined Subsets of Autologous T Cells Engineered to Express a ROR1-Specific Chimeric Antigen Receptor (NCT02706392)

Summary

To take part in this study you must have metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has not responded to other treatment options and that tests positive for ROR1.

This study is assessing the safety, effects (good and bad) and best dose of an experimental CAR-T immunotherapy that targets cancer cells that test positive for ROR1. CAR-T is a personalized immunotherapy made from a patient's white blood cells. The blood cells are removed from the patient and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. The cells are then infused back into the patient in the hospital. The CAR-T therapy being used in this study trains the immune system to attack ROR1-positive tumor cells. It is given along with the chemotherapy drugs fludarabine phosphate and cyclophosphamide. These drugs are given to deplete lymph cells. This study is also enrolling patients with other types of ROR1-positive metastatic tumors.

A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to Patients With CD70 Expressing Cancers (NCT02830724)

Summary

To take part in this study you must have metastatic (stage IV) breast cancer that tests positive for CD70 and you must have already been treated with a standard therapy. This study is investigating the safety and effects (good or bad) of using a new type of CAR-T immunotherapy. CAR-T is a personalized immunotherapy made from a patient's white blood cells. The blood cells are removed from the patient and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. The cells are then infused back into the patient in the hospital. The CAR-T therapy used in this study is designed to get the immune system to see and kill cancer cells that are CD70+. Along with the CAR-T immunotherapy, you will receive the chemotherapy drugs fludarabine and cyclophosphamide. These drugs are given to deplete the lymph cells. You will also receive aldesleukin, a drug that stimulates the growth and development of T cells.
This is a Phase I-II trial

A Phase I Clinical Trial to Evaluate the Safety and Tolerability of Mesothelin-Specific Chimeric Antigen Receptor-Positive T Cells in Patients With Metastatic Mesothelin-Expressing Breast Cancer (CAR-T therapy)(NCT02792114)

Summary

The immune system has two types of white blood cells, B cells and T cells. This study is testing the safety and best dose of an immunotherapy made from your own T cells. Mesothelin is a protein commonly found in breast cancer cells. The mesothelin-targeted T-cell therapy used in this study gets into the cancer cells by attaching itself to these proteins. To take part in this study, you must have HER2-negative metastatic breast cancer and your cancer cells must produce mesothelin proteins. In addition, your doctors must have already used at least one chemotherapy drug to treat your metastatic breast cancer.