DLBCL - Diffuse Large B Cell Lymphoma, FL Lymphoma, Follicular Lymphoma (FL), HGBCL, Lymphoma, Lymphoplasmacytic Lymphoma, PMBCL, Waldenström Macroglobulinemia (WM)
Conditions
Brief summary
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma
Interventions
DRUGMDX2003
MDX2003 intravenous infusion
Sponsors
ModeX Therapeutics, An OPKO Health Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A only- Identify the Maximum Tolerated Dose (MTD) for expansion for further development of MDX2003 | 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) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All Study Parts: Measure of terminal half-life (t1/2) of MDX2003 | 6 months | Characterize pharmacokinetic (PK) parameter t1/2 after intravenous infusion of MDX2003. |
| All Study Parts: Measure of area under the serum concentration-time curve (AUC) of MDX2003 | 6 months | Characterize pharmacokinetic (PK) parameter AUC after intravenous infusion of MDX2003. |
| All Study Parts: Measure of time to maximum concentration (Tmax) of MDX2003 | 6 months | Characterize pharmacokinetic (PK) parameter Tmax after intravenous infusion of MDX2003. |
| All Study Parts: Measure of maximum serum concentration (Cmax) of MDX2003 | 6 months | Characterize pharmacokinetic (PK) parameter Cmax after intravenous infusion of MDX2003. |
| All Study Parts: Measure of volume of distribution (Vd) of MDX2003 | 6 months | Characterize pharmacokinetic (PK) parameter Vd after intravenous infusion of MDX2003. |
| All Study Parts: Measure of system clearance of MDX2003 | 6 months | Characterize pharmacokinetic (PK) parameter of system clearance after intravenous infusion of MDX2003. |
| All Study Parts: Evaluation of MDX2003 immunogenicity | 6 months | The presence and persistence of anti-MDX2003 antibodies. |
Countries
Australia
Contacts
CONTACTModeX Therapeutics, An OPKO Health Company
Outcome results
None listed