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Recruiting Phase 1/2 NCT07249905

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

Phase 1/2 – combined early trial
Conditions: Lymphoma Waldenström Macroglobulinemia (WM) DLBCL - Diffuse Large B Cell Lymphoma PMBCL HGBCL FL Lymphoma Lymphoplasmacytic Lymphoma Follicular Lymphoma (FL)

Sponsor: ModeX Therapeutics, An OPKO Health Company

trial.available_in: БГ
Overview
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma
Who can participate
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.
Locations 1
Australia (1)
Linear Clinical Research
Nedlands , Western Australia
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.03.2026
Completion date
01.04.2030
Registry ID
NCT07249905
Source
anzctr
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