The U.S. Food and Drug Administration (FDA) has cleared the third investigational new drug application for Cabaletta Bio’s 4-1BB–containing, fully human, CD19–chimeric antigen receptor T-cell therapy, CABA-201, in patients with systemic sclerosis, according to a report from Healio. Over the last 6 months, the FDA also cleared the company’s investigational new drug applications for testing the agent in patients with myositis and lupus. CABA-201 was designed to briefly eliminate the body’s B cells to allow for an immune system reset. Researchers will initiate a new open-label phase I/II trial to examine the efficacy of CABA-201 to slow or prevent the progression of systemic sclerosis in patients with severe skin and organ involvement. All of the patients who are enrolled in the trial will undergo a pretreatment conditioning regimen of fludarabine and cyclophosphamide and will then receive single infusion of 1 x 106 cells/kg of the novel agent.
October 12, 2023