Recruiting nowPhase 1/2Ages 18 Years and up
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Sponsor: ModeX Therapeutics, An OPKO Health Company · NCT07249905 on ClinicalTrials.gov ↗
Conditions studied
LymphomaWaldenström Macroglobulinemia (WM)DLBCL - Diffuse Large B Cell LymphomaPMBCLHGBCLFL LymphomaLymphoplasmacytic LymphomaFollicular Lymphoma (FL)
What it tests
- MDX2003drug
Where it's running2 sites
2 international sites
- Recruiting now
Epworth HealthCare
Richmond, Victoria, Australia 3121
- ModeX Therapeutics(contact)+1 857-233-9936[email protected]
- Dr. Costas Yannakou(principal investigator)
- Recruiting now
Linear Clinical Research
Nedlands, Western Australia, Australia 6009
- ModeX Therapeutics(contact)+1 857-233-9936[email protected]
- Dr. Chan Cheah(principal investigator)
See the official eligibility language
Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.
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.
Updated 2026-05-04 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.