A Phase I/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of the EMB-07 Combination Therapy in Patients With Aggressive B-Cell Non-Hodgkin Lymphoma

This is an open-label, multicenter, Phase I/II study designed to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of EMB-07 combination therapy in adult patients with aggressive B-cell non-Hodgkin lymphoma (B-NHL). The study consists two phases: Phase I of dose escalation and Phase II of dose expansion. Approximately 115 patients will be enrolled in this study (i.e., 5 cohorts of approximately 23 patients per cohort). Multiple EMB-07-based combination regimens will be evaluated in patients with relapsed/refractory (R/R) aggressive B-NHL (Cohort A) an

Trial Details

NCT ID
NCT07432022
Phase
PHASE1 / PHASE2
Sponsor
Shanghai EpimAb Biotherapeutics Co., Ltd.
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • EMB07
  • Rituximab/Gemcitabine/Oxaliplatin
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • Ability to understand and voluntarily sign the Informed Consent Form (ICF);
  • Patients aged ≥18 years;
  • Life expectancy \> 12 weeks;
  • ECOG performance status score: ≤1 point during the dose escalation phase, ≤2 points during the dose expansion phase.

For full eligibility, visit ClinicalTrials.gov.

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