MDX2003 for Adults With Relapsed or Hard-to-Treat B-Cell Lymphoma
Tests MDX2003 in adults whose B-cell lymphoma returned or did not respond.
Plain-language title generated from the registry record
Registry title: Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Key facts
- Where
- Seville, SpainSee the site
- Phase
- Phase 1/2
Where in Spain
- Virgen del Rocio University HospitalSeville, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ModeX Therapeutics, An OPKO Health Company
- Trial code
- NCT07249905
- Record updated
- 6 November 2026
- Original description
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphomaRead full original descriptionShow less
A Phase 1/2 Clinical Study Evaluating MDX2003 in Participants With Relapsed, Progressive, or Refractory B-Cell Malignancies
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma
Inclusion: 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: Unresolved toxicities from previous anticancer therapy; 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 or suspected history of hemophagocytic lymphohistiocytosis (HLH); 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 central nervous system (CNS) lymphoma or known CNS involvement with lymphoma.