Phase I Study of SIRPα-Directed Monoclonal Antibody BYON4228 Alone and with Rituximab in Relapsed/Refractory CD20+ B-cell Non-Hodgkin's Lymphoma

The primary objective of this study is to evaluate the **safety**, pharmacokinetics, pharmacodynamics, and efficacy of the SIRPα-directed monoclonal antibody BYON4228, both as a monotherapy and in combination with **rituximab**, in patients with relapsed/refractory CD20 positive B-cell Non-Hodgkin's Lymphoma (NHL). This is clinically relevant as it aims to address the therapeutic needs of patients with this specific subtype of NHL, who have limited treatment options due to the relapsed or refractory nature of their disease.

The clinical trial involves a total of **19 participants** diagnosed with **relapsed/refractory CD20 positive B-cell Non-Hodgkin's Lymphoma (NHL)**. The study population includes both male and female subjects, with an age range that spans from young adults to older adults. Participants were selected based on their diagnosis, and the trial includes a vulnerable population. The selection process did not specify any particular lifestyle considerations such as diet, physical activity, or habits. The sponsor did not provide detailed information regarding the main objective of the trial or specific inclusion criteria.

The clinical trial is designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of the **SIRPα-directed monoclonal antibody BYON4228** alone and in combination with **rituximab** in patients with **relapsed/refractory CD20 positive B-cell Non-Hodgkin's Lymphoma (NHL)**. This is a Phase 1, first-in-human, dose escalation and expansion study. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated duration of the trial is from February 20, 2023, to April 27, 2026.

Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be enrolled in the study and will attend regular follow-up visits to monitor safety, drug levels, and response to treatment. These visits will include comprehensive assessments such as physical examinations, laboratory tests, and imaging studies as required. The end-of-study visit will occur after the completion of the treatment period, where final evaluations will be conducted to assess the overall outcomes and any long-term effects of the treatment.

The expected length of participant involvement in the study will vary depending on the individual response to treatment and the specific cohort assignment. Participants may be withdrawn from the study early if they experience unacceptable toxicity, disease progression, or if they choose to withdraw consent. Additionally, any protocol violations or non-compliance with study procedures may also result in early termination from the study. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on the administration of other medicinal products or their role in the trial.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is not included in the available data. The documentation lacks specifics on the **product's authorization status**, pharmaceutical form, and the origin of the active substances.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating its primary focus on safety and dosage determination, with preliminary efficacy assessments. The estimated recruitment start date is February 20, 2023, and the trial is expected to conclude by April 27, 2026. Although specific efficacy endpoints are not detailed, typical Phase 1 trials may involve the collection of preliminary data on efficacy parameters such as **biomarker levels** or symptom improvement scores. These parameters are often measured using validated scales or laboratory tests at predetermined timepoints throughout the trial duration. The data collected will be analyzed to determine the potential efficacy of the investigational product, guiding further clinical development in subsequent trial phases.