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Recruiting Phase 1, Phase 2 NCT07249905

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

Trial Parameters

Condition Lymphoma
Sponsor ModeX Therapeutics, An OPKO Health Company
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 180
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-03
Completion 2028-01
Interventions
MDX2003

Brief Summary

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

Eligibility Criteria

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 fo

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