Posted by Michael Wonder on 01 Dec 2025
Cullinan Therapeutics receives FDA fast track designation for CLN-049, a novel FLT3xCD3 T cell engager, in relapsed/refractory acute myeloid leukemia
1 December 2025 - Cullinan Therapeutics today announced that the US FDA has granted fast track designation to CLN-049 for the treatment of relapsed/refractory acute myeloid leukaemia.
CLN-049 is a novel, investigational FLT3xCD3 bi-specific T cell engager. CLN-049 is designed to target FLT3-expressing leukaemia cells, offering a new immunotherapeutic approach for treating acute myeloid leukaemia and myelodysplastic syndrome.
