ClinicalTrials.gov record NCT07249905

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

A Phase 1/2 Clinical Study Evaluating MDX2003 in Participants With Relapsed, Progressive, or Refractory B-Cell Malignancies

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
Age18 years old and older
SexAll
LocationAustralia
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 1/2 study tests MDX2003 given by intravenous infusion in people with relapsed, progressive, or refractory B‑cell malignancies. It includes a dose‑escalation part to find a dose for expansion and a dose‑expansion part to assess preliminary anti-lymphoma activity. The study collects safety, response, and drug‑behavior (pharmacokinetic and immunogenicity) data.

What it is studying. The study is testing MDX2003 given by IV infusion to characterize safety and tolerability, identify a maximum tolerated dose for expansion, measure how the drug behaves in the body (pharmacokinetics), assess immune responses to the drug, and estimate preliminary anti-lymphoma activity (objective response rate).

What the researchers hope to learn. Scientific goals: characterize safety and tolerability of MDX2003; identify the maximum tolerated dose for expansion; measure adverse events and serious adverse events; assess preliminary anti‑lymphoma activity (objective response rate per Lugano Classification); and characterize pharmacokinetic parameters (t1/2, AUC, Tmax, Cmax, volume of distribution, clearance) and immunogenicity (anti‑MDX2003 antibodies).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • MDX2003

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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.
  • All participants must have measurable disease via computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)-CT.
  • Documented CD19 or CD20 positivity of their B-cell neoplasm based on any representative pathology report from the past 3 months.
  • Adequate hematologic, hepatic and renal function.
  • All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Capable of giving signed informed consent.

Exclusion criteria

  • 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.
  • Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infection requiring intravenous treatment.
  • Participant has a history of allogenic tissue or solid organ transplant, with the exception of corneal transplants.
  • Known hypersensitivity to allopurinol or rasburicase.
  • Participant has a seizure disorder requiring therapy at the time of screening (such as steroids or anti-epileptics).
  • Participant is not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive the study drug MDX2003 by intravenous (IV) infusion in a dose‑finding part or an expansion part. They will attend regular clinic visits for treatment and follow‑up, with medical assessments and laboratory tests to monitor safety and side effects (safety is tracked from baseline until 90 days after the last dose). Imaging (CT, MRI, or PET‑CT) will be used to document and follow tumor response. Tests to measure drug levels and to check for anti‑drug antibodies are planned for up to six months.

How the study is structured. This is a non-randomized, open-label, single‑group Phase 1/2 interventional trial with two parts. Part A is dose escalation: participants receive IV infusions of MDX2003 to determine a tolerated dose for further study. Part B is dose expansion/indication optimization: participants with selected B‑cell malignancies receive MDX2003 at the chosen dose to assess preliminary activity. Safety and adverse events are monitored through treatment and for at least 90 days after the last dose; pharmacokinetic and immunogenicity measurements are collected for several months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in Australia. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Waldenström macroglobulinemia

Clinical trials63 trials listed for Waldenström macroglobulinemiaEvery trial the registry lists for Waldenström macroglobulinemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Waldenström macroglobulinemia researchLatest monthly update: September 2026. Includes: Upfront treatment outcomes. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Apr 13, 2026
Primary completion
January 2028 (estimated)
Study completion
April 2030 (estimated)
Target enrollment
180 participants (estimated)
Last updated on registry
May 4, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
ModeX Therapeutics, An OPKO Health Company

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (2)

Terms used on this page · explanations by MedicalUpdates.ai

relapsed
A condition that improved with treatment and has since returned or worsened.
prior lines
Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
ECOG
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
computed tomography
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
magnetic resonance imaging
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
positron emission tomography
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
prednisone
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
immunosuppressive
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials