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RecruitingLast updated: 11 May 2026

Evaluating a medicine called MDX2003 in people with relapsed, progressive, or refractory B-cell malignanciesA Phase 1/2 Clinical Study Evaluating MDX2003 in Participants With Relapsed, Progressive, or Refractory B-Cell Malignancies

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Clinical summary

Summary

This study is designed to understand how safe and tolerable a medicine called MDX2003 is, as well as assess its anti-cancer effect. 

You may be eligible for this study if you have relapsed, progressive, or refractory B-cell cancers. This includes:

  • Diffuse large B-cell lymphoma (DLBCL)
  • high-grade B-cell lymphoma (HGBCL)
  • primary mediastinal B-cell lymphoma (PMBCL)
  • Follicular lymphoma (FL)
  • Mantle cell lymphoma (MCL)
  • Marginal zone lymphoma (MZL)
  • Transformation of indolent B-cell lymphoma
  • Lymphoplasmacytic lymphoma
  • Waldenstrom macroglobulinemia

MDX2003 will be given as an intravenous (IV) infusion.

Conditions

This trial is treating people with B-cell malignancies

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

ModeX Therapeutics, An OPKO Health Company

Scientific Title

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

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