This Study is Designed to Characterize the Safety, Tolerability, and Anti-tumor Activity of MDX2003 in Patients With Different Types of Lymphoma

NCT ID: NCT07249905

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2030-04-30

Brief Summary

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

Conditions

Lymphoma; Waldenström Macroglobulinemia (WM); DLBCL - Diffuse Large B Cell Lymphoma; PMBCL; HGBCL; FL Lymphoma; Lymphoplasmacytic Lymphoma; Follicular Lymphoma (FL)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation- Part A

Participants with B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion.

Group Type: EXPERIMENTAL

MDX2003

Intervention Type: DRUG

MDX2003 intravenous infusion

Indication Optimization- Part B

Participants with select B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion.

Group Type: EXPERIMENTAL

MDX2003

Intervention Type: DRUG

MDX2003 intravenous infusion

Interventions

MDX2003

MDX2003 intravenous infusion

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ModeX Therapeutics, An OPKO Health Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

ModeX Therapeutics, An OPKO Health Company

Role: CONTACT

info@modextx.com

+1 857-233-9936

Other Identifiers

MDX-2003-101

Identifier Type: -

Identifier Source: org_study_id