LymphomaWaldenström Macroglobulinemia (WM)DLBCL - Diffuse Large B Cell LymphomaPMBCLHGBCLFL LymphomaLymphoplasmacytic LymphomaFollicular Lymphoma (FL)
Investigational drug(s) / intervention(s)
MDX2003
MDX2003: MDX2003 intravenous infusion
Study summary
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Part A only- Identify the Maximum Tolerated Dose (MTD) for expansion for further development of MDX2003 — 28 days 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.
All Study Parts: Adverse Events (AEs) — Baseline until 90 days after the participant has the last dose of MDX2003 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.
Part B only- Assess the preliminary anti-lymphoma activity of MDX2003 — From date of enrollment until the end of treatment, up to approximately 6 months Objective response rate is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per Lugano Classification.
Trial sites (2)
Facility
City
Region
Status
Epworth HealthCare
Richmond
Victoria
Recruiting
Linear Clinical Research
Nedlands
Western Australia
Recruiting
More ModeX Therapeutics, An OPKO Health Company trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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