Cullinan Therapeutics announced updated positive data from its Phase 1 dose escalation clinical trial of CLN-049 in patients with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The results demonstrated notable anti-leukemic activity and a favorable safety profile, particularly with an optimized two step-up dosing regimen.
Key Details
- Efficacy: At the 12 µg/kg target dose level with an optimized step-up regimen, the trial showed a 53% overall response rate (ORR) and a 26% composite complete remission (CRc) rate in 19 patients.
- Safety Profile: The implementation of a two step-up dosing regimen reduced the incidence of cytokine release syndrome (CRS) to 26% (from 36% with a single step-up) and limited its severity to Grade 1-2. It also mitigated liver transaminase elevations.
- Future Presentation: The updated data from the 87-patient trial will be presented at the 68th American Society of Hematology (ASH) Annual Meeting in December 2026. These results support the ongoing Phase 2 clinical trial of CLN-049.