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

April 30, 2026 updated by: ModeX Therapeutics, An OPKO Health Company

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: ModeX Therapeutics, An OPKO Health Company
  • Phone Number: +1 857-233-9936
  • Email: info@modextx.com

Study Locations

  • Australia
    • Victoria
      • Richmond, Victoria, Australia, 3121
        • Recruiting
        • Epworth Healthcare
        • Contact:
        • Principal Investigator:
          • Dr. Costas Yannakou
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Linear Clinical Research
        • Contact:
        • Principal Investigator:
          • Dr. Chan Cheah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation- Part A
Participants with B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion.
Drug: MDX2003
MDX2003 intravenous infusion
Experimental: Indication Optimization- Part B
Participants with select B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion.
Drug: MDX2003
MDX2003 intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A only- Identify the Maximum Tolerated Dose (MTD) for expansion for further development of MDX2003
Time Frame: 28 days
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.
28 days
All Study Parts: Adverse Events (AEs)
Time Frame: Baseline until 90 days after the participant has the last dose of MDX2003
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.
Baseline until 90 days after the participant has the last dose of MDX2003
Part B only- Assess the preliminary anti-lymphoma activity of MDX2003
Time Frame: From date of enrollment until the end of treatment, up to approximately 6 months
Objective response rate is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per Lugano Classification.
From date of enrollment until the end of treatment, up to approximately 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All Study Parts: Measure of terminal half-life (t1/2) of MDX2003
Time Frame: 6 months
Characterize pharmacokinetic (PK) parameter t1/2 after intravenous infusion of MDX2003.
6 months
All Study Parts: Measure of area under the serum concentration-time curve (AUC) of MDX2003
Time Frame: 6 months
Characterize pharmacokinetic (PK) parameter AUC after intravenous infusion of MDX2003.
6 months
All Study Parts: Measure of time to maximum concentration (Tmax) of MDX2003
Time Frame: 6 months
Characterize pharmacokinetic (PK) parameter Tmax after intravenous infusion of MDX2003.
6 months
All Study Parts: Measure of maximum serum concentration (Cmax) of MDX2003
Time Frame: 6 months
Characterize pharmacokinetic (PK) parameter Cmax after intravenous infusion of MDX2003.
6 months
All Study Parts: Measure of volume of distribution (Vd) of MDX2003
Time Frame: 6 months
Characterize pharmacokinetic (PK) parameter Vd after intravenous infusion of MDX2003.
6 months
All Study Parts: Measure of system clearance of MDX2003
Time Frame: 6 months
Characterize pharmacokinetic (PK) parameter of system clearance after intravenous infusion of MDX2003.
6 months
All Study Parts: Evaluation of MDX2003 immunogenicity
Time Frame: 6 months
The presence and persistence of anti-MDX2003 antibodies.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModeX Therapeutics, An OPKO Health Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDX-2003-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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