Clinical Trial TitleDescartes-11 in relapsed or refractory multiple myeloma.
Clinical Trial Protocol Description:
Multiple myeloma is a cancer that begins in plasma cells, a type of white blood cell. With multiple myeloma, plasma cells grow out of control in the bone marrow and form tumors in the areas of solid bone. The growth of these bone tumors weakens the solid bones. It also makes it harder for the bone marrow to make healthy blood cells and platelets.
Chimeric Antigen Receptor (CAR) T-cell therapy is a type of immunotherapy that uses specially altered T cells (a type of immune system cell), to more specifically target cancer cells. The immune system is made up of specific cells and organs that protect the body from infection and cancer. Among these are T cells, which hunt down and destroy abnormal cells, including cancer cells. Sometimes, cancer cells find ways to evade the immune system; so, the immune system needs to be retrained to recognize and attack cancer cells. CAR T-cell therapy is one innovative approach to program the immune system to attack cancer.
Blood from a vein in a patient’s arm flows through a tube to an apheresis machine which removes the white blood cells, including the T cells and sends the rest of the blood back to the patient. Then, the gene for a special receptor called a chimeric antigen receptor (CAR) is inserted into the T cells in a laboratory. Millions of the CAR T cells are grown in the laboratory and then given to the patient by infusion following chemotherapy. The CAR T cells multiply in the patient's blood and are able to bind to an antigen on the cancer cells and kill them.
The main purpose of this study is to evaluate the safety of an investigational cell-based therapy called Descartes-11. This will be the first time Descartes-11 has been tried in patients with multiple myeloma, although a similar investigational cell-based therapy has been tried before in patients with multiple myeloma.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have disease that has grown or been resistant to at least 2 lines of treatment or you could not tolerate the other 2 therapies.
- Are 18 years of age or older.
- Have adequate vital organ function.
You will be excluded from the study if any of the following criteria apply to you:
- Have any active or uncontrolled infection.
- Have HIV, hepatitis B or hepatitis C.
- Have active cardiac arrhythmias, active obstructive or restrictive pulmonary disease
- Have had a venous thromboembolic event, such as a pulmonary embolism or deep vein thrombosis.
- Have inadequate bone marrow function.
This is a partial list of inclusion and exclusion criteria.