Full Title
A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Subjects with Active Idiopathic Inflammatory Myopathy or Active Juvenile Idiopathic Inflammatory Myopathy (WCG IRB)Purpose
Researchers are seeking the best dose of CABA-201 to treat people with active idiopathic inflammatory myopathy (IIM). The people in this study have IIM, juvenile idiopathic inflammatory myopathy (JIIM), or myositis. With JIIM and some subtypes of IIM, B cells make the body to attack different tissues, causing inflammation and muscle weakness.
CABA-201 is a chimeric antigen receptor (CAR) T cell therapy. With CAR T cell therapy, some of your own T cells (a type of white blood cell) are removed. They are genetically changed in a lab to find and remove B cells, including the B cells causing your disease.
Before you get CABA-201, you may receive fludarabine and cyclophosphamide. These chemotherapy drugs briefly weaken your immune system and help prepare your body to receive the CAR T cells. The treatments in this study are given intravenously (by vein).
Who Can Join
To join this study, there are a few conditions. You must:
- Have active IIM, JIIM, or myositis that is not getting better with treatment or is getting worse.
- Be age 18-75.
Contact
For more information and to see if you can join this study, please call Dr. Jae Park’s office at 888-675-2278 (CAR T line).