This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma
Participant must be ≥ 18 years of age.
Participant has a confirmed diagnosis of large B-cell lymphoma (including DLBCL, high-grade B-cell lymphoma [HGBCL], primary mediastinal B-cell lymphoma [PMBCL], etc), FL, MCL, marginal zone lymphoma, transformation of indolent B-cell lymphoma, or lymphoplasmacytic lymphoma, including Waldenstrom macroglobulinemia.
Participant has relapsed or progressed on at least 2 prior lines of therapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).
Unresolved toxicities from previous anticancer therapy.
Primary central nervous system (CNS) lymphoma or known CNS involvement with lymphoma.
Active medical condition requiring chronic systemic steroid use (>10 mg/day prednisone or equivalent of >140 mg over the last 14 days) or immunosuppressive therapy, within 6 months prior to the first dose of MDX2003.
Single group
MDX2003
DrugMDX2003 intravenous infusion
Part A only- Identify the Maximum Tolerated Dose (MTD) for expansion for further development of MDX2003
Maximum Tolerated Dose is determined following the evaluation of MDX2003 safety, including the incidences of dose-limiting toxicities (DLTs), MDX2003 anti-tumor activity, and MDX2003 pharmacokinetics/pharmacodynamics.
All Study Parts: Adverse Events (AEs)
Incidence and severity of adverse events (AEs) and serious AEs (SAEs), including changes in clinical laboratory parameters, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria, including changes in clinical laboratory parameters.
Part B only- Assess the preliminary anti-lymphoma activity of MDX2003
Objective response rate is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per Lugano Classification.
All Study Parts: Measure of terminal half-life (t1/2) of MDX2003
Characterize pharmacokinetic (PK) parameter t1/2 after intravenous infusion of MDX2003.
All Study Parts: Measure of area under the serum concentration-time curve (AUC) of MDX2003
Characterize pharmacokinetic (PK) parameter AUC after intravenous infusion of MDX2003.
All Study Parts: Measure of time to maximum concentration (Tmax) of MDX2003
Characterize pharmacokinetic (PK) parameter Tmax after intravenous infusion of MDX2003.
All Study Parts: Measure of maximum serum concentration (Cmax) of MDX2003
Characterize pharmacokinetic (PK) parameter Cmax after intravenous infusion of MDX2003.
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