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

NCT07249905 | Recruiting Phase 1

• 1 other identifier: MDX-2003-101
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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

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

Outcome Measures

Primary Outcomes (3)

• Part A only- Identify the Maximum Tolerated Dose (MTD) for expansion for further development of MDX2003

  Maximum Tolerated Dose is determined following the evaluation of MDX2003 safety, including the incidences of dose-limiting toxicities (DLTs), MDX2003 anti-tumor activity, and MDX2003 pharmacokinetics/pharmacodynamics.

  28 days

• All Study Parts: Adverse Events (AEs)

  Incidence and severity of adverse events (AEs) and serious AEs (SAEs), including changes in clinical laboratory parameters, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria, including changes in clinical laboratory parameters.

  Baseline until 90 days after the participant has the last dose of MDX2003

• Part B only- Assess the preliminary anti-lymphoma activity of MDX2003

  Objective response rate is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per Lugano Classification.

  From date of enrollment until the end of treatment, up to approximately 6 months

Secondary Outcomes (7)

• All Study Parts: Measure of terminal half-life (t1/2) of MDX2003

  6 months

• All Study Parts: Measure of area under the serum concentration-time curve (AUC) of MDX2003

  6 months

• All Study Parts: Measure of time to maximum concentration (Tmax) of MDX2003

  6 months

• All Study Parts: Measure of maximum serum concentration (Cmax) of MDX2003

  6 months

• All Study Parts: Measure of volume of distribution (Vd) of MDX2003

  6 months

Study Arms (2)

Dose Escalation- Part A

EXPERIMENTAL

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

Drug: MDX2003

Indication Optimization- Part B

EXPERIMENTAL

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

Drug: MDX2003

Interventions

MDX2003 DRUG

MDX2003 intravenous infusion

Dose Escalation- Part A; Indication Optimization- Part B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• ModeX Therapeutics, An OPKO Health Company: lead

Study Sites (2)

Epworth HealthCare

Richmond, Victoria, 3121, Australia

RECRUITING

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

RECRUITING

MeSH Terms

Conditions

Lymphoma; Waldenstrom Macroglobulinemia; Dendritic Cell Sarcoma, Interdigitating; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Histiocytic Disorders, Malignant; Histiocytosis; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell

Central Study Contacts

ModeX Therapeutics, An OPKO Health Company

CONTACT

+1 857-233-9936; info@modextx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: April 13, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): April 1, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)