Actively Recruiting
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Led by ModeX Therapeutics, An OPKO Health Company · Updated on 2026-05-04
180
Participants Needed
2
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma
CONDITIONS
Official 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.
- Participant has a confirmed diagnosis of large B-cell lymphoma (including DLBCL, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, etc.), follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, transformation of indolent B-cell lymphoma, or lymphoplasmacytic lymphoma including Waldenstrom macroglobulinemia.
- Participant has relapsed or progressed after at least two prior lines of therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Measurable disease confirmed by CT, MRI, or PET-CT.
- Documented CD19 or CD20 positivity of the B-cell neoplasm based on pathology report within the past 3 months.
- Adequate blood, liver, and kidney function.
- Use of contraception consistent with local regulations for men and women.
- Able to give signed informed consent.
You will not qualify if you...
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).
- Unresolved toxicities from previous cancer treatment.
- Primary central nervous system lymphoma or known CNS involvement with lymphoma.
- Active medical condition requiring chronic systemic steroids (>10 mg/day prednisone or equivalent over last 14 days) or immunosuppressive therapy within 6 months before first MDX2003 dose.
- Known HIV infection, active hepatitis B or C, or uncontrolled infections needing intravenous treatment.
- History of allogenic tissue or organ transplant (except corneal transplant).
- Known allergy to allopurinol or rasburicase.
- Seizure disorder requiring treatment at screening.
- Any condition judged by the investigator to make participation unsuitable.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here