A Phase I Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of a CD19/CD20 T-cell Engager in Patients with Systemic Lupus Erythematosus

The primary objective is to evaluate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of a CD19/CD20 T-cell engager in individuals diagnosed with systemic lupus erythematosus. This investigation aims to characterize the profile of the therapeutic agent within the context of B-cell driven autoimmune rheumatic disease.

This clinical trial involves a total of 27 patients. The study population consists of individuals diagnosed with systemic lupus erythematosus. The cohort includes both male and female participants. Based on the provided age range codes, the subjects fall within specific age categories. The sponsor did not provide additional information regarding lifestyle considerations or specific selection methodologies.

This Phase 3 clinical trial is designed to investigate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of a CD19/CD20 T-cell engager in individuals diagnosed with systemic lupus erythematosus. The study methodology involves a structured sequence of clinical assessments. The process begins with a screening visit to evaluate eligibility. Subsequent follow-up visits are conducted to monitor physiological responses and therapeutic effects, concluding with an end-of-study visit. The total duration of the trial is estimated to continue until December 31, 2027. Participation may be subject to early termination based on predefined clinical criteria or safety protocols.

Efficacy assessment in this Phase 3 clinical trial for systemic lupus erythematosus is not specified in the provided documentation.