NCT07249905 Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
| NCT ID | NCT07249905 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | ModeX Therapeutics, An OPKO Health Company |
| Condition | Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2026-04-13 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 180 participants in total. It began in 2026-04-13 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07249905 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07249905 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07249905 currently recruiting?
Yes, NCT07249905 is actively recruiting participants. Contact the research team at info@modextx.com for enrollment information.
Where is the NCT07249905 trial being conducted?
This trial is being conducted at Richmond, Australia, Nedlands, Australia.
Who is sponsoring the NCT07249905 clinical trial?
NCT07249905 is sponsored by ModeX Therapeutics, An OPKO Health Company. The trial plans to enroll 180 participants.