A Phase 1 Open-label Preliminary Pharmacokinetics (PK) and Safety Study of CLN-049 (An fms-like tyrosine kinase 3 [FLT3] x cluster of differentiation 3 [CD3] bispecific T cell engager) in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML)

Brief description of study

The purpose of the study is to determine the safety and tolerability of intravenous (IV) administered CLN-049. CLN-049 is a novel BITE therapy that target FLT3. We want to characterize select pharmacokinetic (PK) parameters associated with IV-administered CLN-049 and we also want to evaluate the immunogenicity of CLN-049 and assess potential impact on PK exposure.The study drug CLN-049 is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.


Clinical Study Identifier: s20-01861
ClinicalTrials.gov Identifier: NCT05143996
Principal Investigator: Mohammad Maher Abdul Hay.
Other Investigators: Shella Saint Fleur-Lominy, Kenny Tai, Jun Han Choi.


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