Actively Recruiting
A Phase 1/2 Study Evaluating MDX2003 in Adults With Relapsed or Refractory B-Cell Lymphoma
Led by ModeX Therapeutics, An OPKO Health Company · Updated on 2026-05-04
180
Participants Needed
2
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and anti-tumor activity of MDX2003 in patients with various types of lymphoma. This phase 1/2 study focuses on participants with relapsed, progressive, or refractory B-cell malignancies, including several lymphoma subtypes such as diffuse large B-cell lymphoma, follicular lymphoma, and Waldenstrom macroglobulinemia. The study aims to identify the appropriate dose and assess early signs of treatment effectiveness in this population. Participants will receive MDX2003 through intravenous infusion. The study is divided into two parts: Part A involves dose escalation to determine the maximum tolerated dose, while Part B focuses on dose expansion to optimize treatment for selected lymphoma types. Treatment schedules and dosing details will be guided by safety and response assessments during the trial. During the study, participants will undergo regular evaluations including imaging scans like CT, MRI, or PET-CT to measure disease status, and laboratory tests to monitor blood, liver, and kidney function. Researchers will track adverse events from the start of treatment until 90 days after the last dose, as well as pharmacokinetic measures of MDX2003 over six months. The primary outcomes include establishing the safe dose and observing preliminary anti-lymphoma effects, with total participation lasting up to about six months or longer depending on study part.
CONDITIONS
Brief Title
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older.
- Confirmed diagnosis of large B-cell lymphoma (including DLBCL, HGBCL, PMBCL), follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, transformation of indolent B-cell lymphoma, or lymphoplasmacytic lymphoma including Waldenstrom macroglobulinemia.
- Relapsed or progressed after at least two prior lines of therapy.
- ECOG performance status of 0 to 2.
- Measurable disease by CT, MRI, or PET-CT imaging.
- Documented CD19 or CD20 positivity based on pathology within the past 3 months.
- Adequate blood, liver, and kidney function.
- Use of contraception consistent with local regulations during the study.
- Ability to provide signed informed consent.
You will not qualify if you...
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).
- Unresolved toxicities from previous anticancer treatments.
- Primary central nervous system lymphoma or known CNS involvement.
- Active medical conditions requiring chronic systemic steroids (>10 mg/day prednisone or equivalent) or immunosuppressive therapy within 6 months before first dose.
- Known HIV infection, active hepatitis B or C, or uncontrolled infections requiring intravenous treatment.
- History of allogenic tissue or solid organ transplant, except corneal transplants.
- Known allergy to allopurinol or rasburicase.
- Seizure disorder requiring treatment at screening.
- Any condition judged by the investigator to make participation unsuitable for medical or clinical reasons.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 6 months
Participants receive MDX2003 as an intravenous infusion to treat B-cell lymphoma.
Duration - 90 days after the last dose
Participants are monitored for adverse events and treatment effects after the last dose of MDX2003.
Approximately 1 to 2 visits
Trial Site Locations
Total: 2 locations
1
Epworth HealthCare
Richmond, Victoria, Australia, 3121
Actively Recruiting
2
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
M
ModeX Therapeutics, An OPKO Health Company
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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