LymphomaPhase 1/2NCT07249905
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
A Phase 1/2 study testing MDX2003 in people with Lymphoma and Waldenström Macroglobulinemia (WM), run by ModeX Therapeutics, An OPKO Health Company at 7 sites in 3 countries.
Trial summary
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Waldenström Macroglobulinemia (WM), DLBCL - Diffuse Large B Cell Lymphoma
- What is being tested?
- MDX2003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 13 Apr 2026to Apr 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
Israel4 sites, 4 recruiting
- Recruiting
Rambam Medical Center
Haifa
ModeX Therapeutics, +1 857-233-9936, info@modextx.com
Shimrit Ringelstein
- Recruiting
Hadassah Medical Center
Jerusalem, 91120
ModeX Therapeutics, +1 857-233-9936, info@modextx.com
Shlomzion Aumann
- Recruiting
Rabin Medical Center - Beilinson Hospital
Petah Tikva
ModeX Therapeutics, +1 857-233-9936, info@modextx.com
Ronit Gurion
- Recruiting
Tel-Aviv Sourasky Medical Center
Tel Aviv
ModeX Therapeutics, +1 857-233-9936, info@modextx.com
Irit Avivi
Australia2 sites, 2 recruiting
- Recruiting
Linear Clinical Research
Nedlands, Western Australia, 6009
ModeX Therapeutics, +1 857-233-9936, info@modextx.com
Dr. Chan Cheah
- Recruiting
Epworth HealthCare
Richmond, Victoria, 3121
ModeX Therapeutics, +1 857-233-9936, info@modextx.com
Dr. Costas Yannakou
Spain1 site, 1 recruiting
- Recruiting
Virgen del Rocío University Hospital
Seville, 41013
ModeX Therapeutics, +1 857-233-9936, info@modextx.com
Fatima de la Cruz Vicente
About this study
Official title: A Phase 1/2 Clinical Study Evaluating MDX2003 in Participants With Relapsed, Progressive, or Refractory B-Cell Malignancies
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma
- Conditions
- Lymphoma, Waldenström Macroglobulinemia (WM), DLBCL - Diffuse Large B Cell Lymphoma, PMBCL, HGBCL, FL Lymphoma
- Being tested
- MDX2003
- Medical subject headings
- Lymphoma, Waldenstrom Macroglobulinemia, Dendritic Cell Sarcoma, Interdigitating, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDX2003Drug
MDX2003 intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation- Part A | Experimental | Participants with B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion. Receives: Drug: MDX2003 |
| Indication Optimization- Part B | Experimental | Participants with select B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion. Receives: Drug: MDX2003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A only- Identify the Maximum Tolerated Dose (MTD) for expansion for further development of MDX2003
Maximum Tolerated Dose is determined following the evaluation of MDX2003 safety, including the incidences of dose-limiting toxicities (DLTs), MDX2003 anti-tumor activity, and MDX2003 pharmacokinetics/pharmacodynamics.
Measured: 28 days
All Study Parts: Adverse Events (AEs)
Incidence and severity of adverse events (AEs) and serious AEs (SAEs), including changes in clinical laboratory parameters, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria, including changes in clinical laboratory parameters.
Measured: Baseline until 90 days after the participant has the last dose of MDX2003
Part B only- Assess the preliminary anti-lymphoma activity of MDX2003
Objective response rate is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per Lugano Classification.
Measured: From date of enrollment until the end of treatment, up to approximately 6 months
Secondary outcomes (7)
All Study Parts: Measure of terminal half-life (t1/2) of MDX2003
Characterize pharmacokinetic (PK) parameter t1/2 after intravenous infusion of MDX2003.
Measured: 6 months
All Study Parts: Measure of area under the serum concentration-time curve (AUC) of MDX2003
Characterize pharmacokinetic (PK) parameter AUC after intravenous infusion of MDX2003.
Measured: 6 months
All Study Parts: Measure of time to maximum concentration (Tmax) of MDX2003
Characterize pharmacokinetic (PK) parameter Tmax after intravenous infusion of MDX2003.
Measured: 6 months
All Study Parts: Measure of maximum serum concentration (Cmax) of MDX2003
Characterize pharmacokinetic (PK) parameter Cmax after intravenous infusion of MDX2003.
Measured: 6 months
All Study Parts: Measure of volume of distribution (Vd) of MDX2003
Characterize pharmacokinetic (PK) parameter Vd after intravenous infusion of MDX2003.
Measured: 6 months
All Study Parts: Measure of system clearance of MDX2003
Characterize pharmacokinetic (PK) parameter of system clearance after intravenous infusion of MDX2003.
Measured: 6 months
All Study Parts: Evaluation of MDX2003 immunogenicity
The presence and persistence of anti-MDX2003 antibodies.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start13 Apr 2026
- Primary completionJan 2028 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ModeX Therapeutics, An OPKO Health Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249905
- Sponsor's protocol ID
- MDX-2003-101
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Clinical Study Evaluating MDX2003 in Participants With Relapsed, Progressive, or Refractory B-Cell Malignancies
- ClinicalTrials.gov ID
- NCT07249905
- Acronym / sponsor ID
- MDX-2003-101
- Conditions
- Lymphoma, Waldenström Macroglobulinemia (WM), DLBCL - Diffuse Large B Cell Lymphoma, PMBCL, HGBCL, FL Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- ModeX Therapeutics, An OPKO Health CompanyIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation- Part A | Experimental | Drug: MDX2003Participants with B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion. |
| Indication Optimization- Part B | Experimental | Drug: MDX2003Participants with select B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDX2003MDX2003 intravenous infusion | Drug | Dose Escalation- Part A, Indication Optimization- Part B |
Primary outcome
Part A only- Identify the Maximum Tolerated Dose (MTD) for expansion for further development of MDX2003
Time frame: 28 days
Maximum Tolerated Dose is determined following the evaluation of MDX2003 safety, including the incidences of dose-limiting toxicities (DLTs), MDX2003 anti-tumor activity, and MDX2003 pharmacokinetics/pharmacodynamics.
All Study Parts: Adverse Events (AEs)
Time frame: Baseline until 90 days after the participant has the last dose of MDX2003
Incidence and severity of adverse events (AEs) and serious AEs (SAEs), including changes in clinical laboratory parameters, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria, including changes in clinical laboratory parameters.
Part B only- Assess the preliminary anti-lymphoma activity of MDX2003
Time frame: From date of enrollment until the end of treatment, up to approximately 6 months
Objective response rate is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per Lugano Classification.
7 secondary outcomes
All Study Parts: Measure of terminal half-life (t1/2) of MDX2003
Time frame: 6 months
All Study Parts: Measure of area under the serum concentration-time curve (AUC) of MDX2003
Time frame: 6 months
All Study Parts: Measure of time to maximum concentration (Tmax) of MDX2003
Time frame: 6 months
All Study Parts: Measure of maximum serum concentration (Cmax) of MDX2003
Time frame: 6 months
All Study Parts: Measure of volume of distribution (Vd) of MDX2003
Time frame: 6 months
All Study Parts: Measure of system clearance of MDX2003
Time frame: 6 months
All Study Parts: Evaluation of MDX2003 immunogenicity
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MDX2003 in people with Lymphoma and Waldenström Macroglobulinemia (WM), run by ModeX Therapeutics, An OPKO Health Company at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Israel, Australia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ModeX Therapeutics, An OPKO Health Company (+1 857-233-9936, info@modextx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A only- Identify the Maximum Tolerated Dose (MTD) for expansion for further development of MDX2003 (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.