Phase 2 study

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 2
Sponsor ModeX Therapeutics, An OPKO Health Company
Registry number NCT07249905
Started 13 April 2026 Today 16 October 2026 Estimated completion 1 January 2028

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Epworth HealthCare Richmond VIC Recruiting
Linear Clinical Research Nedlands WA Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 180

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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.

Dates on the record

Started 13 April 2026
Estimated completion 1 January 2028
Registry last updated 4 May 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 4 May 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.