MDX2003 for adults with relapsed B‑cell lymphomas

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

This trial will test MDX2003 in adults with relapsed or refractory B‑cell lymphomas whose tumors are CD19 or CD20 positive to see if it is safe and can shrink tumors.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ModeX Therapeutics, An OPKO Health Company (industry)
• Drugs / interventions: prednisone
• Locations: 2 sites (Richmond, Victoria and 1 other locations)
• Trial ID: NCT07249905 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 program uses a dose‑escalation phase to find a tolerable dose of MDX2003 followed by dose‑expansion cohorts to look for anti‑tumor activity across different B‑cell lymphoma types. Eligible participants are adults with measurable, relapsed or progressive disease after at least two prior lines of therapy and must show CD19 or CD20 positivity. The study will monitor safety, tolerability, pharmacokinetics, and preliminary efficacy using standard imaging and response criteria. Patients must meet laboratory and performance status requirements and agree to contraception consistent with local regulations.

Who should consider this trial

Good fit: Adults (≥18) with relapsed or progressive B‑cell lymphomas after at least two prior therapies, measurable disease, ECOG 0–2, adequate organ function, and documented CD19 or CD20 positivity are the intended participants.

Not a fit: Patients without CD19/CD20 expression, those who have not received the required prior therapies, or those with poor organ function or performance status may not benefit or may be ineligible.

Why it matters

Potential benefit: If successful, MDX2003 could offer a new treatment option that shrinks tumors or delays progression in patients with relapsed B‑cell lymphomas.

How similar studies have performed: Other CD19/CD20‑targeted approaches such as monoclonal antibodies and CAR‑T therapies have shown clinical benefit in B‑cell lymphomas, but MDX2003 is a novel agent being tested in early‑phase trials.

Eligibility criteria

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.

Where this trial is running

Richmond, Victoria and 1 other locations

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

Study contacts

• Study coordinator: ModeX Therapeutics, An OPKO Health Company

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