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

Recruiting now · Phase 1/Phase 2

Conditions studied: Lymphoma, Waldenström Macroglobulinemia (WM), DLBCL - Diffuse Large B Cell Lymphoma, PMBCL, HGBCL, FL Lymphoma, Lymphoplasmacytic Lymphoma, Follicular Lymphoma (FL)

In brief

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

Key facts

Study ID

NCT07249905

Run by

ModeX Therapeutics, An OPKO Health Company

People needed

180

Starts

2026-04-13

Expected to finish

2030-04-01

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Epworth HealthCare — Richmond, Victoria, Australia (enrolling)
• Linear Clinical Research — Nedlands, Western Australia, Australia (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.