Phase 1 Evaluation of Allo-RevCAR01-T-CD123 in CD123 Positive Hematologic Malignancies, Including Acute Myeloid Leukemia (AML)

The primary objective of this Phase 1 study is to evaluate the safety and tolerability of **Allo-RevCAR01-T-CD123** in patients with selected CD123 positive hematologic malignancies, specifically focusing on **Acute Myeloid Leukemia (AML)**. This is clinically relevant as AML is an aggressive form of cancer with limited treatment options, and understanding the safety profile of this novel therapy could inform future therapeutic strategies.

The clinical trial focuses on participants diagnosed with **Acute Myeloid Leukemia (AML)**. The study population includes both male and female subjects, encompassing an age range that includes both adults and older adults. The trial involves a vulnerable population, indicating that special considerations are in place for the participants' safety and well-being. However, the sponsor has not provided information regarding the total number of participants involved in the study. The selection process for the trial population and any specific lifestyle considerations, such as diet or physical activity, have not been disclosed. Key inclusion or exclusion criteria are also not specified in the available data.

The clinical trial is a **Phase 1** study designed to evaluate the safety and efficacy of Allo-RevCAR01-T-CD123 in patients diagnosed with **Acute Myeloid Leukemia (AML)**. The trial employs a randomized, double-blind, and controlled design to ensure the reliability and validity of the results. The estimated duration of the trial spans from July 1, 2023, to April 30, 2027, allowing for comprehensive data collection and analysis over this period.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a thorough review of the participant's medical history and baseline assessments. Following successful inclusion, participants will attend regular follow-up visits, which are scheduled to monitor the treatment's effects and any adverse events. These visits will include clinical evaluations, laboratory tests, and other necessary assessments to ensure participant safety and data integrity. The end-of-study visit will mark the conclusion of the participant's involvement, where final evaluations will be conducted to gather comprehensive data on the treatment's impact.

The expected length of participant involvement in the trial is contingent upon individual response to the treatment and adherence to the study protocol. Conditions that may lead to early termination from the study include the occurrence of significant adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The trial is structured to maintain the highest ethical standards and prioritize participant safety throughout its duration.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the **experimental medication**, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific information, additional relevant details about drug administration, dosing schedules, and participant compliance monitoring are also not included. The absence of data on the **experimental medication** and non-experimental treatments limits the ability to provide a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, with an estimated recruitment start date of July 1, 2023, and an estimated end date of April 30, 2027. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, the trial will likely involve systematic data collection and analysis to determine the treatment's impact. The methods for measuring and analyzing efficacy will adhere to standard clinical trial protocols, ensuring the reliability and validity of the results. The trial's duration and phase indicate an early-stage investigation, focusing on initial assessments of the treatment's effects.