Phase 12 Study of MDX2003 Treatment in Adults with Relapsed or Refractory B-Cell Lymphomas

What this Trial Is About

Researchers are evaluating the safety, tolerability, and anti-tumor activity of MDX2003 in patients with various types of lymphoma. This phase 12 study focuses on participants with relapsed, progressive, or refractory B-cell malignancies, including several lymphoma subtypes such as diffuse large B-cell lymphoma, follicular lymphoma, and Waldenstrom macroglobulinemia. The study aims to identify the appropriate dose and assess early signs of treatment effectiveness in this population. Participants will receive MDX2003 through intravenous infusion. The study is divided into two parts Part A involves dose escalation to determine the maximum tolerated dose, while Part B focuses on dose expansion to optimize treatment for selected lymphoma types. Treatment schedules and dosing details will be guided by safety and response assessments during the trial. During the study, participants will undergo regular evaluations including imaging scans like CT, MRI, or PET-CT to measure disease status, and laboratory tests to monitor blood, liver, and kidney function. Researchers will track adverse events from the start of treatment until 90 days after the last dose, as well as pharmacokinetic measures of MDX2003 over six months. The primary outcomes include establishing the safe dose and observing preliminary anti-lymphoma effects, with total participation lasting up to about six months or longer depending on study part.

Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma