Fate Therapeutics announces FDA clearance of FT839 IND application

Fate Therapeutics announced that the FDA has cleared its investigational new drug, or IND, application for FT839, the company's next-generation, off-the-shelf CAR T-cell product candidate engineered to co-target CD19 and CD38. With IND clearance, the company plans to advance FT839 into a basket clinical trial intended to evaluate the product candidate across a range of autoimmune diseases when administered in combination with standard-of-care therapy and without dependence on conditioning chemotherapy. Enrollment in the Phase 1/2 study is expected to commence in the second half of 2026.