What is the study therapy?
The study therapy, called CLR 131, is an intravenous infusion administered up to 4 times over 3 months through an IV, and each infusion takes about 20 minutes. The study therapy is designed to use radiation to target the cancer in your body. Unlike other radiation therapies you may have heard of, the study therapy is designed to limit exposure of your healthy, normal tissue to radiation.
Blood diseases like Waldenstrom Macroglobulinemia (WM) have been shown to be highly responsive to radiation therapies. Over 100 adult and pediatric cancer patients have been dosed in previous clinical studies with the study therapy, including WM patients. These include previous efficacy and safety studies where the CLR 131 has been shown to be safe and have activity in WM and other diseases. This has given the study team more information about how the study therapy works, how safe it is, and how it might help people with multiple types of cancer.
The study therapy uses a radioactive version of iodine, which the thyroid absorbs easily. Because of this, participants will take an approved drug during the study therapy cycles to protect their thyroids from radiation absorption.
What is an investigational therapy?
The study therapy, CLR 131, is an investigational study therapy. An investigational study therapy is one that has not been approved by the US Food and Drug Administration (FDA) or any other regulatory agency.