A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With Relapsed or Refractory B-Cell Malignancies

What this Trial Is About

Researchers are evaluating AZD5492, an experimental T cell-engaging antibody targeting CD20, in participants with relapsed or refractory B-cell malignancies. This Phase I/II study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD5492 in adults who have undergone at least two prior treatments for their B-cell cancer. The study is sponsored by AstraZeneca and focuses on mature B-cell neoplasms including various lymphomas and chronic lymphocytic leukemia. Participants will receive AZD5492 as monotherapy, administered subcutaneously. The study includes a dose escalation and dose expansion approach to find the appropriate dose. Treatment safety and tolerability will be closely monitored from the first dose through up to 90 days after the last dose, with follow-up for response and survival outcomes continuing up to two years after treatment. During the study, participants will undergo regular safety assessments, including monitoring for dose-limiting toxicities and treatment-related adverse events. Pharmacokinetic measurements will track drug levels and clearance, while immunogenicity will be evaluated. Researchers will also assess overall and complete response rates, duration of response, progression-free survival, and overall survival. The total study participation involves initial treatment cycles and extended follow-up to capture long-term outcomes and safety data.

A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies.