Clinical trial · Interventional
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
A Phase 1/2 Clinical Study Evaluating MDX2003 in Participants With Relapsed, Progressive, or Refractory B-Cell Malignancies
NCT07249905CI-TRIAL-00110181recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DLBCL - Diffuse Large B Cell Lymphoma | — | UNRESOLVED | — |
| FL Lymphoma | — | UNRESOLVED | — |
| Follicular Lymphoma (FL) | Follicular Lymphoma | ONTOLOGY_EXACT | 0.85 |
| HGBCL | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoplasmacytic Lymphoma | Lymphoplasmacytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
| PMBCL | — | UNRESOLVED | — |
| Waldenström Macroglobulinemia (WM) | Waldenstrom Macroglobulinemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MDX2003 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation- Part A
- description
- Participants with B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion.
- interventionNames
- Drug: MDX2003
- type
- EXPERIMENTAL
- label
- Indication Optimization- Part B
- description
- Participants with select B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion.
- interventionNames
- Drug: MDX2003
Primary outcomes (3)
- measure
- Part A only- Identify the Maximum Tolerated Dose (MTD) for expansion for further development of MDX2003
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.