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NCT07249905

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

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)
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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 2 → 6 locations
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 1 of 7 entries
  2. Study sites: 1 to 2
    • Start date changed from estimate of Mar 2026 to Apr 13, 2026
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Study title shortened, about 6 words
    v2
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Part A only- Identify the Maximum Tolerated Dose (MTD) for expansion for further development of MDX2003
Timeframe: 28 days
All Study Parts: Adverse Events (AEs)
Timeframe: Baseline until 90 days after the participant has the last dose of MDX2003
Part B only- Assess the preliminary anti-lymphoma activity of MDX2003
Timeframe: From date of enrollment until the end of treatment, up to approximately 6 months

Secondary (7)

All Study Parts: Measure of terminal half-life (t1/2) of MDX2003
All Study Parts: Measure of area under the serum concentration-time curve (AUC) of MDX2003
All Study Parts: Measure of time to maximum concentration (Tmax) of MDX2003
All Study Parts: Measure of maximum serum concentration (Cmax) of MDX2003
All Study Parts: Measure of volume of distribution (Vd) of MDX2003
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All Study Parts: Measure of system clearance of MDX2003
All Study Parts: Evaluation of MDX2003 immunogenicity

Arms and interventions

Dose Escalation- Part AExperimental

Participants with B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion.

Indication Optimization- Part BExperimental

Participants with select B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion.

Drugs: MDX2003

Sites

6 sites in 2 countries

Israel 4, Australia 2