Cullinan Therapeutics (CGEM) announced new clinical data from its Phase 1 study of CLN-049, a novel, investigational FLT3xCD3 bispecific T cell engager, in patients with relapsed/refractory acute myeloid leukemia, AML, and myelodysplastic syndrome, MDS. Updated data will be presented at the 67th American Society of Hematology, ASH, Annual Meeting and Exposition, being held December 6-9 in Orlando, Florida, as an oral presentation on Monday, December 8. Title: Preliminary Anti-leukemia Activity from A Phase 1 Study of CLN-049, a Novel Anti-FLT3 x Anti-CD3 Bispecific T-Cell Engager, in Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome. Efficacy Results: Anti-leukemic activity was observed at target doses greater than or equal to6 undefined/kg, with a CRc rate of 30%, and ORR of 57%. At the highest target dose studied thus far of 12 undefined/kg, CRc rate was 31% and ORR was 69%. In 9/23 patients achieving bone marrow blasts less than5%, 33% patients were MRD negative by flow cytometry; relapse was not observed in MRD-negative patients, and 1 patient has remained on study for greater than6 months. Responses were observed in patients with AML regardless of baseline genetic risk.
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