Recruiting NCT07249905

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

Phase I / Phase II Interventional Lymphoma Waldenström Macroglobulinemia (WM) DLBCL - Diffuse Large B Cell Lymphoma PMBCL

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: MDX2003.
Who it may be relevant to: Registry conditions: Lymphoma, Waldenström Macroglobulinemia (WM), DLBCL - Diffuse Large B Cell Lymphoma, PMBCL. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Australia
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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

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

Part A only- Identify the Maximum Tolerated Dose (MTD) for expansion for further development of MDX2003 [Time frame: 28 days]
All Study Parts: Adverse Events (AEs) [Time frame: Baseline until 90 days after the participant has the last dose of MDX2003]
Part B only- Assess the preliminary anti-lymphoma activity of MDX2003 [Time frame: From date of enrollment until the end of treatment, up to approximately 6 months]

Secondary outcome measures (7)

All Study Parts: Measure of terminal half-life (t1/2) of MDX2003 [Time frame: 6 months]
All Study Parts: Measure of area under the serum concentration-time curve (AUC) of MDX2003 [Time frame: 6 months]
All Study Parts: Measure of time to maximum concentration (Tmax) of MDX2003 [Time frame: 6 months]
All Study Parts: Measure of maximum serum concentration (Cmax) of MDX2003 [Time frame: 6 months]
All Study Parts: Measure of volume of distribution (Vd) of MDX2003 [Time frame: 6 months]
All Study Parts: Measure of system clearance of MDX2003 [Time frame: 6 months]
All Study Parts: Evaluation of MDX2003 immunogenicity [Time frame: 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Australia · 2 centers

NCT: NCT07249905 · MDX-2003-101