This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
MDX2003 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.
Time frame: 28 days
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.
Time frame: Baseline until 90 days after the participant has the last dose of MDX2003
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.
Time frame: From date of enrollment until the end of treatment, up to approximately 6 months
All Study Parts: Measure of terminal half-life (t1/2) of MDX2003
Characterize pharmacokinetic (PK) parameter t1/2 after intravenous infusion of MDX2003.
Time frame: 6 months
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.
Time frame: 6 months
All Study Parts: Measure of time to maximum concentration (Tmax) of MDX2003
Characterize pharmacokinetic (PK) parameter Tmax after intravenous infusion of MDX2003.
Time frame: 6 months
All Study Parts: Measure of maximum serum concentration (Cmax) of MDX2003
Characterize pharmacokinetic (PK) parameter Cmax after intravenous infusion of MDX2003.
Time frame: 6 months
All Study Parts: Measure of volume of distribution (Vd) of MDX2003
Characterize pharmacokinetic (PK) parameter Vd after intravenous infusion of MDX2003.
Time frame: 6 months
All Study Parts: Measure of system clearance of MDX2003
Characterize pharmacokinetic (PK) parameter of system clearance after intravenous infusion of MDX2003.
Time frame: 6 months
All Study Parts: Evaluation of MDX2003 immunogenicity
The presence and persistence of anti-MDX2003 antibodies.
Time frame: 6 months
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