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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorModeX Therapeutics, An OPKO Health Company

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • MDX2003

Treatment groups

180 Participants
are divided into 2 treatment groups