Phase 1 Open-Label Dose Escalation and Expansion Study of CLN-049 in Acute Myeloid Leukemia with Measurable Residual Disease

The primary objective of this study is to evaluate the safety and tolerability of **CLN-049** in patients with **Acute Myeloid Leukemia (AML)** who have measurable residual disease (MRD). This is clinically relevant as it aims to determine the potential of CLN-049 to manage MRD, which is a critical factor in the prognosis and treatment outcomes of AML. The study is designed as a Phase 1, open-label, dose escalation and dose expansion trial, focusing on the initial assessment of the therapeutic profile of CLN-049 in this specific patient population.

The clinical trial involves participants diagnosed with **Acute Myeloid Leukemia (AML) with Measurable Residual Disease (MRD)**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. The trial population is noted to include vulnerable groups, although specific details regarding the selection process or lifestyle considerations such as diet and physical activity are not provided. The sponsor has not disclosed the total number of participants involved in the study. Key inclusion or exclusion criteria have not been specified in the available data.

The clinical trial is designed to evaluate the safety and efficacy of CLN-049 in patients with **Acute Myeloid Leukemia (AML)** who have measurable residual disease (MRD). This is a Phase 1, open-label, dose escalation and dose expansion study. The trial is expected to commence on January 15, 2024, and conclude by January 5, 2026. The study will involve a series of visits, beginning with an inclusion visit where participants will be screened for eligibility based on specific criteria. Following successful screening, participants will be enrolled in the study and will undergo a series of follow-up visits to monitor their response to the treatment and any potential adverse effects. The trial will conclude with an end-of-study visit to assess the overall outcomes and gather final data.

Participants are expected to be involved in the study for the duration of the trial, which may vary depending on individual response to the treatment and the specific protocol of the dose escalation and expansion phases. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or any other medical reasons deemed necessary by the investigators. The study aims to provide valuable insights into the potential therapeutic benefits of CLN-049 for patients with AML and MRD, contributing to the advancement of treatment options for this condition.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these treatments can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be offered regarding these aspects of the clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on January 15, 2024, with an estimated completion date of January 5, 2026. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters are not specified. The trial will adhere to rigorous standards typical of Phase 3 studies, ensuring that the data collected is robust and reliable. The trial's design and execution will follow established protocols to ensure the validity and reliability of the efficacy assessments.