In short
MDX2003 is an investigational drug substance being studied in a single clinical trial for people with relapsed or refractory B-cell malignancies. The trial is authorised in the EU and has a planned enrolment of 80 participants. It is a Phase 1/2 study evaluating safety, tolerability, and early signs of anti-lymphoma activity.
Key points
- MDX2003 is being tested in relapsed/refractory B-cell malignancies.
- The trial is in Phase 1/2 and is currently authorised.
- Up to 80 participants are planned to be enrolled.
- The study evaluates safety, tolerability, and preliminary anti-lymphoma activity.
- MDX2003 is given by intravenous infusion.
- The trial record is available in the EU Clinical Trials Information System (CTIS).
What is MDX2003?
MDX2003 is an investigational substance being studied in people with advanced B-cell malignancies, which are cancers affecting a type of white blood cell called B lymphocytes. It is not yet authorised as a medicine. The name MDX2003 is a development code used for this investigational drug.
How does MDX2003 work?
The trial record does not describe the mechanism of action of MDX2003 in detail. The study is designed to evaluate safety, tolerability, and preliminary anti-lymphoma activity, meaning researchers are assessing how the drug affects B-cell cancers and how the body responds to it.
Which conditions is MDX2003 being studied for?
- Relapsed/refractory B-cell malignancies — cancers of B lymphocytes that have either returned after treatment (relapsed) or have not responded to previous treatment (refractory).
How is MDX2003 given?
MDX2003 is given by intravenous infusion, meaning it is administered directly into a vein over a period of time.
What do the clinical trials show?
The clinical development of MDX2003 consists of one registered trial, which is authorised in the EU and has a planned enrolment of 80 participants. The study is divided into two parts. Part A focuses on safety and tolerability, with the goal of identifying recommended doses for further development. Part B assesses the preliminary anti-lymphoma activity of MDX2003.
The primary outcome measures differ between the two parts. In Part A, the main measure is the incidence and severity of adverse events and serious adverse events, including changes in clinical laboratory parameters, graded according to CTCAE v5.0 or ASTCT consensus grading criteria. Safety, efficacy, pharmacokinetics, and pharmacodynamics are also assessed. In Part B, the main measure is the objective response rate (ORR) according to the Lugano Classification, which is a standard way of assessing response to treatment in lymphoma.
The trial is interventional, meaning participants receive the investigational drug as part of the study. The condition studied is relapsed/refractory B-cell malignancies, and the study status is authorised.
What side effects are known?
The trial record does not provide a list of known side effects for MDX2003. The study itself is designed to collect information on adverse events and serious adverse events during the trial.