Investigation of HDP-102 in Patients with Relapsed/Refractory B-cell Malignancies

The primary objective of this study is to evaluate the efficacy and safety of the investigational medicine **HDP-102** in patients with **relapsed/refractory B-cell malignancies**. This is clinically relevant as these malignancies often present treatment challenges due to their resistance to standard therapies, necessitating the development of new therapeutic options. The study aims to provide insights into the potential of HDP-102 to improve patient outcomes in this difficult-to-treat population.

The clinical trial involves a total of **16 participants** diagnosed with **relapsed/refractory B-cell malignancies**. The study population includes both male and female subjects, with an age range encompassing **adolescents and adults**. Participants were selected based on specific criteria, although the principal inclusion criteria were not provided. The trial includes a vulnerable population, indicating that special considerations may be necessary for their participation. Lifestyle factors such as diet, physical activity, or habits were not specified. The selection process aimed to ensure a representative sample of the affected population, although detailed selection criteria were not disclosed by the sponsor.

The clinical trial is designed to evaluate an investigational medicine, HDP-102, in patients with **relapsed/refractory B-cell malignancies**. This study is structured as a Phase 1 trial, which is typically the initial phase in clinical research aimed at assessing the safety, tolerability, and pharmacokinetics of a new drug. The trial will employ a randomized, double-blind, controlled design to ensure unbiased results and to compare the investigational drug against a control. The estimated recruitment start date is April 15, 2025, with the trial expected to conclude by April 30, 2028, indicating a total duration of approximately three years.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. This visit will involve a comprehensive assessment, including medical history, physical examination, and laboratory tests. Following successful screening, participants will be randomized into treatment groups. Subsequent follow-up visits will be scheduled at regular intervals to monitor the participants' health, assess the drug's effects, and collect data on safety and efficacy. These visits will include physical examinations, laboratory tests, and possibly imaging studies, depending on the study protocol. The end-of-study visit will mark the conclusion of a participant's involvement, during which final assessments will be conducted to gather comprehensive data on the investigational drug's impact.

The expected length of participant involvement will vary depending on individual response and the study's progression, but it is anticipated to last throughout the trial's duration unless early termination criteria are met. Conditions that may lead to early termination from the study include adverse reactions, withdrawal of consent, or any significant protocol deviations. Participants will be closely monitored throughout the trial to ensure their safety and well-being, with all procedures conducted in accordance with ethical guidelines and regulatory requirements.

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. Consequently, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not included. The absence of this data precludes a comprehensive description of the treatments used in the study.

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 April 15, 2025, and an estimated end date of April 30, 2028. Although specific efficacy parameters or endpoints are not detailed, Phase 1 trials typically focus on assessing safety, tolerability, and pharmacokinetics, which may indirectly inform efficacy. The trial will adhere to a predefined schedule for measuring and collecting data, though specific timepoints and methods are not provided. The analysis of efficacy will be conducted using standard clinical trial methodologies appropriate for the trial phase. The trial will ensure that all assessments are conducted using validated tools and instruments, although these are not specified in the available data.