MDX2003 for adults with relapsed B‑cell lymphomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Epworth HealthCare
  Richmond, Victoria, Australia Recruiting
• Linear Clinical Research
  Nedlands, Western Australia, Australia Recruiting
• Rambam Medical Center
  Haifa, Israel Recruiting
• Hadassah Medical Center
  Jerusalem, Israel Recruiting
• Rabin Medical Center - Beilinson Hospital
  Petah Tikva, Israel Recruiting
• Tel-Aviv Sourasky Medical Center
  Tel Aviv, Israel Recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.