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Recruiting nowPhase 1/2Ages 18 Years and up

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

Sponsor: ModeX Therapeutics, An OPKO Health Company · NCT07249905 on ClinicalTrials.gov ↗

Conditions studied

LymphomaWaldenström Macroglobulinemia (WM)DLBCL - Diffuse Large B Cell LymphomaPMBCLHGBCLFL LymphomaLymphoplasmacytic LymphomaFollicular Lymphoma (FL)

What it tests

  • MDX2003drug

Where it's running2 sites

2 international sites
  • Epworth HealthCare

    Richmond, Victoria, Australia 3121

    Recruiting now
  • Linear Clinical Research

    Nedlands, Western Australia, Australia 6009

    Recruiting now
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

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.

Updated 2026-05-04 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.