FDA Approves Phase 1 Trial of CNTY-101 for People with Systemic Lupus Erythematosus
The U.S. Food and Drug Administration has cleared (when a clinical study sponsor receives approval to administer an investigational drug or biological product to humans) the investigational therapy, CNTY-101, for treatment of systemic lupus erythematosus (SLE). Researchers will initiate Phase 1 study next year on people with standard to severe SLE that have not responded to at least two standard immunosuppressive treatments.
CNTY-101 includes an allogenic chimeric antigen receptors (CAR) therapy created by scientists or engineers that use immune cells from healthy people and is designed to destroy B cells (immune system cells involved in the production of autoantibodies and lupus disease activity). CNTY-101 is made of modified immune NK cells (or lymphocytes) which help destroy infected and diseased cells in the body. It is the first therapy engineered with six gene edits. In the trial, participants will undergo chemotherapy treatments to erase the person’s immune cells, then, for three weeks, they will receive one or two doses of CNTY-101.
Initial Phase 1 data are expected by year-end 2024. Continue to follow the Lupus Foundation of America for updates on lupus drug developments and clinical trials. Learn more about treatments being studied for lupus.
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