BridgeMD
New treatment option for Lymphoma
Official title Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
ClinicalTrials.gov ID: NCT07249905
What this study is testing
What is MDX2003?
MDX2003 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infection requiring...
- Participant has a history of allogenic tissue or solid organ transplant, with the exception of corneal transplants.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Richmond, Victoria, Australia
- Nedlands, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Richmond, Victoria, Australia; Nedlands, Western Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.