Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma

Sponsor
ModeX Therapeutics, An OPKO Health Company
Study ID
NCT07249905
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • DLBCL - Diffuse Large B Cell Lymphoma
  • FL Lymphoma
  • Follicular Lymphoma (FL)
  • HGBCL
  • Lymphoma
  • Lymphoplasmacytic Lymphoma
  • PMBCL
  • Waldenström Macroglobulinemia (WM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MDX2003 — DRUG
    MDX2003 intravenous infusion

Study Details

This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma

Key Dates

First listed
Nov 25, 2025
Start date
Apr 13, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Apr 30, 2030

Study Design

Enrollment
180 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation- Part A
    Participants with B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion.
  • Experimental: Indication Optimization- Part B
    Participants with select B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion.

Primary Outcome Measure

Part A only- Identify the Maximum Tolerated Dose (MTD) for expansion for further development of MDX2003 [ Time Frame: 28 days ]

Central Contacts

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