What type of study is this?

This is a Pre-Registered Trial study.

What question did this study set out to answer?

The research aims to evaluate the safety and efficacy of CLN-049 in patients with relapsed/refractory AML and MDS.

December 8, 2025Blood

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The research aims to evaluate the safety and efficacy of CLN-049 in patients with relapsed/refractory AML and MDS.
40 patients aged ≥ 18 years with R/R AML or MDS were enrolled.
CLN-049 was administered intravenously in a multiple ascending dose design.
Efficacy endpoints included complete response rates and overall response rates.
95% of patients experienced treatment-emergent adverse events.
At doses ≥ 6 µg/kg, CR rate was 9% and ORR was 57% among efficacy evaluable patients.
Responses were observed in patients with AML regardless of baseline genetic risk.

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Phase 1 trial reports anti-leukemic activity of CLN-049 in relapsed/refractory AML and MDS, suggesting its potential for treatment.

Vale et al. (2025) studied this question.

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