NEW YORK – Gracell Biotechnologies on Monday said it has launched an investigator-initiated trial of its autologous CAR T-cell therapy GC012F in patients in China with refractory systemic lupus erythematosus (SLE).
The company, located in San Diego and Shanghai and Suzhou, China, has developed GC012F to target both CD19 and B-cell maturation antigens and is using its FasTCAR platform for next-day manufacturing. The CAR T-cell therapy has already been studied in 50 patients with hematologic malignancies and shown a 93.1 percent overall response rate in relapsed and refractory multiple myeloma patients and a 100 percent overall response rate in newly diagnosed patients.
Gracell now wants to explore GC012F's activity in autoimmune diseases such as SLE, a condition affecting more than 3 million people globally in which the patient's own immune system turns on and attacks tissues. This can cause severe organ damage from which patients die. Currently immunosuppressants are used to treat SLE, but there's a need for better therapies.
According to Gracell Founder, Chairman, and CEO William Cao, the firm hopes to prepare an IND submission for GC012F seeking permission to conduct clinical trials involving SLE patients in the US as well as in China.