CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

This trial is divided into 5 parts: Part A - Single Ascending Dose (SAD) - Patients will receive a single dose of CLN-049 via IV administration and be followed for safety for 28 days Part B - Multiple Ascending Dose (MAD) - Patients will receive CLN-049 every 7 days (q7d) after an initial Lead-In Dose via IV administration and be followed for safety for 28 days and will then enter long-term follow-up for up to 2 years Part C - Multiple Ascending Dose (MAD) - Patients will receive CLN-049 q7d via SC injection and be followed for safety for 28 days and will then enter long-term follow-up for up to 2 years Part D - a Phase 2 Dose Optimization and Expansion of IV administered CLN-049 - patients will be randomized 1:1 to one of two dose regimens derived from doses tested during Part B (MAD-IV). Following selection of the RP2D in Dose Optimization, additional patients will be enrolled at the RP2D in Expansion. Part E - a Phase 2 Dose Expansion of IV administered CLN-049 - an exploratory hypothesis-generating expansion cohort that will test CLN-049 at the RP2D (as determined in Part D Dose Optimization) in newly diagnosed, previously untreated AML patients with TP53 mutations. Enrollment in Part A concluded in May 2022. Enrollment in Part C concluded in July 2024.