Refractory Lupus Nephritis Clinical Trial
Official title:
A Phase 1b, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of TAK-007, an Allogeneic Anti-CD19 Chimeric Antigen Receptor Natural Killer Cell (CD19 CAR-NK) Therapy, in Adult Subjects With Refractory Lupus Nephritis
The main aim of the study is to learn how well adults with refractory lupus nephritis (LN) tolerate TAK-007 and to check for side effects (adverse events). Other aims are to learn how effective treatment with TAK-007 is in adults with refractory LN, what effects TAK-007 has on the human body, and whether participants will produce antibodies against TAK-007.
The drug being tested in this study is called TAK-007. TAK-007 is being tested to treat people with refractory LN. This study will look at the safety and tolerability of TAK-007. The study will enroll approximately 20 patients. Participants will receive a single dose of TAK-007, which is an anti-CD19 chimeric antigen receptor natural killer cell (CD19 CAR-NK) therapy. Participants will be treated with 3 days of intravenous (IV) lymphodepleting chemotherapy (LDC) and then after a gap of at least 2 days, a single IV dose of TAK-007 on Day 1. This multi-center trial will be conducted in the United States. The overall time to participate in this study is approximately 24 months. ;