RecruitingPhase 1Phase 2NCT07249905

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

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

Sponsor

ModeX Therapeutics, An OPKO Health Company

Enrollment

180 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

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.

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.